Stockwinners Market Radar for November 09, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

PRAX

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20:07 EST FDA places Praxis Precision Medicines' PRAX-114 IND on full clinical hold - Praxis Precision Medicine announced that it has received a response from the FDA on the Investigational New Drug, or IND, submission for PRAX-114 for the treatment of major depressive disorder. In October 2020, Praxis submitted the IND for PRAX-114 in connection with the initiation of its randomized, placebo-controlled Phase 2/3 clinical trial for PRAX-114 in MDD, as previously discussed with the FDA at a pre-IND meeting earlier this year. At the end of the 30-day IND review period, the FDA notified the company that the IND has been placed on full clinical hold. The FDA has not provided any reason for the clinical hold. The company has subsequently been in communication with the FDA, which advised that comments have not been finalized. The company expects to receive final comments from the FDA within 30 days and intends to work closely with the agency to understand and resolve key issues.
LOW HDS

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19:49 EST Lowe's says not in discussions with HD Supply, no plans to pursue transaction - Lowe's (LOW) states: "While it is the company's practice to not comment on rumors or speculation, we believe it is important to note that Lowe's is not in discussions with HD Supply (HDS) and we have no plans to pursue a transaction with them."
GLD

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19:46 EST SPDR Gold Shares holdings fall from 1,252.42MT to 1,249.79MT - This is the lowest level of holdings since September 18th.
SUPN

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19:00 EST Supernus trading resumes
PII

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18:36 EST Polaris CEO: Demand has been incredibly strong - In an interview on CNBC's Mad Money, Scott Wine said, "Our suppliers are working their tails off." He noted it's not fair to think the company's suppliers could ramp up production 50% in a short period of time. Wine felt that retail would have been stronger this quarter if suppliers could keep pace with demand.
SUPN

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18:33 EST Supernus Pharmaceuticals backs FY20 net product sales view $500M-$525M - Backs FY20 R&D expense view roughly $75M. Raises FY20 operating earnings view to $155M-$170M from $145M-$160M.
SUPN

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18:32 EST Supernus receives RTF letter from FDA regarding SPN-830 NDA - Supernus Pharmaceuticals said it received a Refusal to File letter from the FDA regarding its NDA for SPN-830 for the continuous treatment of motor fluctuations in Parkinson's disease. In its review of the NDA, which was submitted in September 2020, the FDA determined that the NDA was not sufficiently complete to permit a substantive review. In the letter, the FDA requested certain documents and reports to be submitted in support of the application. The company plans to seek guidance from the FDA, including a Type A meeting, to discuss the contents of the RTF letter and clarify the steps required for the resubmission of the NDA for SPN-830.
SUPN

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18:31 EST Supernus says FDA issues CRL regarding SPN-812 NDA - Supernus Pharmaceuticals announced regulatory updates for SPN-812 for the treatment of attention-deficit hyperactivity disorder in pediatric patients 6 to 17 years of age, and SPN-830 for the continuous treatment of motor fluctuations in Parkinson's disease. The U.S. Food and Drug Administration has issued a Complete Response Letter regarding the New Drug Application for SPN-812 for the treatment of ADHD in pediatric patients 6 to 17 years of age. The FDA issued a CRL to indicate that the review cycle for the application is complete and that the application is not ready for approval in its present form. The primary issue cited in the SPN-812 CRL relates to the Company's in-house laboratory that conducts analytical testing, which recently moved to a new location. The Company plans to discuss with the FDA the contents of the CRL and clarify to the FDA that the application does not rely solely on this facility for product release. We plan to discuss with the agency the steps required for the resubmission of the NDA for SPN-812. Importantly, no clinical safety or efficacy issues were identified during the review.
LLY

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18:23 EST Eli Lilly's COVID-19 antibody bamlanivimab receives FDA EUA - The U.S. FDA issued an emergency use authorization for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions. The EUA was issued to Eli Lilly and Company. Reference Link
SUPN

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18:20 EST Supernus trading halted, news pending
SOR

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18:01 EST Source Capital declares special distribution of 64c per share - Payable on December 15 to shareholders of record on November 27.
ASUR

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18:00 EST Asure Software CFO Jay Powers resigns, John Pence succeeds - John Pence was named CFO effective immediately, replacing Jay Powers. Pence has 28 years of leadership experience in accounting, finance, and operations at a variety of both publicly-traded and privately-held technology companies that served both large and small businesses. Most recently, he served as CFO of a HR benefits provider and helped direct an exit for the company's investors. CFO Jay Powers resigned due to family health reasons. The company has not yet confirmed Powers' last day, which will be dependent upon our need for transition support.
MWA

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17:55 EST Mueller Water sees FY21 CapEx $80M-$90M
POWI

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17:55 EST Power Integrations CEO sells 50K shares of common stock - In a regulatory filing, Power Integrations disclosed that its CEO Balu Balakrishnan sold 50K shares of common stock on November 5th in a total transaction size of $3.26M. The holding represents about 8% of his total owned.
PZN

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17:54 EST Pzena Investment reports AUM of $33.4B as of October 31
WPM

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17:44 EST Wheaton Precious Metals raises quarterly dividend 20% to 12c per share - The fourth quarterly cash dividend for 2020 of gross 12c will be paid to holders of record of Wheaton Precious Metals common shares as of the close of business on November 25 and will be distributed on or about December 10, with an ex-dividend trading date anticipated to be December 8.
GD

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17:44 EST General Dynamics awarded $138.55M Navy contract - General Dynamics was awarded a $138.55M firm-fixed-price contract for the execution of the USS New York FY21 docking selected restricted availability, or DSRA. This availability will include a combination of maintenance, modernization and repair of the USS New York. This is a Chief of Naval Operations scheduled DSRA. The purpose is to maintain, modernize, and repair the USS New York. This is a "long-term" docking availability and was solicited on a coast-wide basis without limiting the place of performance to the vessel's homeport. NASSCO will provide the facilities and human resources capable of completing, coordinating, and integrating multiple areas of ship maintenance, repair, and modernization for USS New York. This contract includes options which, if exercised, would bring the cumulative value of this contract to $161.34M. Work will be performed in Norfolk, Virginia and is expected to be completed by June 2022. FY21 operation and maintenance and FY19 other procurement funding in the amount of $138.55M will be obligated at time of award and will expire at the end of the current fiscal year. This contract was competitively procured using full and open competition via the Federal Business Opportunities website; two competitive proposals were received in response to Solicitation No. N00024-20-R-4417. The Naval Sea Systems Command is the contracting activity.
LMT

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17:36 EST Lockheed Martin awarded $258.31M Air Force ESS contract - Lockheed Martin has been awarded a $258.31M firm-fixed-price contract for evolved strategic satellite communication, or ESS, contract. This contract will develop a prototype payload and conclude in a hardware and software in-the-loop, end-to-end demonstration. Work will be performed in Denver, Colorado, and is expected to be completed June 2025. This contract is the result of a sole-source acquisition. FY20 research, development, test and evaluation funds in the amount of $29.45M are being obligated at the time of award. Space and Missile Systems Center is the contracting activity.
BA

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17:34 EST Boeing awarded $657.2M Air Force contract action modification - Boeing has been awarded a $657.2M undefinitized contract action modification to a contract for the F-15Q Qatar program. The contract modification provides a comprehensive sparing program and contractor logistics support for the sustainment of the F-15QA aircraft. Logistical support for training devices and administrative costs are also included in this modification. Work will be performed in Al-Udeid Air Base, Qatar. Foreign Military Sales funds in the amount of $55.7M are being obligated at the time of award. Total cumulative face value of the contract is $8.04B. Air Force Life Cycle Management Center is the contracting activity.
BYND...

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17:32 EST Beyond Meat says worked very hard to develop McDonald's McPlant burger - Beyond Meat (BYND) says really values customer relationships. Says in regards to McPlant that it is McDonald's (MCD) show and their investor day. Says news on Beyond Burger with McPlant would have taken away from their investor day. Says could not be more excited about launching Beyond Burger 3.0. Says 7,000 CVS Health (CVS) locations to offer Beyond Burger and 5,000 locations to offer Beyond Meatballs.
WPRT

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17:23 EST Westport expects stronger sales in Q4 - The COVID-19 global pandemic continued to have an adverse impact on the business. During the Q3 the Company saw a recovery in its business compared to the Q2 however the extent, duration and impact of COVID-19 is uncertain. The majority of production is from three facilities located in Northern Italy and one in the Netherlands, and sales from these facilities are primarily to Western and Eastern Europe, which are areas that have been significantly impacted by the virus and continue to be challenged to contain the virus and keep the economy operating. Following a COVID19-related temporary shutdown of its facilities in mid-March, the Company's European HPDI launch partner reopened its production facilities in late April and has seen a return to pre-COVID-19 sales volume levels for the HPDI 2.0 product in the Q3, with stronger sales expected in the Q4. The Company's light-duty OEM and DOEM businesses are dependent on new vehicle sales with gaseous fuel systems. Sales revenue in these businesses declined significantly during the Q2 due to the impact of the COVID-19 pandemic, but saw increased revenue in the Q3. It is expected that the Company's heavy-duty business will be less impacted than the IAM and light-duty OEM businesses due to on-going need for freight transportation and the growing demand for climate-friendly products. Demand for essential goods remains and consumer delivery of these goods has increased, resulting in more stable demand and sales of medium and heavy-duty trucks.
BYND

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17:21 EST Beyond Meat falls 29% to $107.28 after Q3 results miss estimates
BYND MCD

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17:18 EST Beyond Meat says brand deserves to be shown on McDonald's menu - Beyond Meat (BYND) says not ok for brand to not show up on McDonald's (MCD) menu. Says brand deserves to be on the menu. Says nearly all QSR partnerships have done that and benefitted. Says can't speak for McDonalds on how they will move forward.
STAY

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17:17 EST Extended Stay America sees FY20 CapEx $170M-$190M - Sees FY20 net income 31M-$45Mand Adjusted EBITDA $363M-$373M.
GLPG

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17:15 EST Galapagos, OncoArendi in collaboration and license pact for OATD-01 - Galapagos and OncoArendi Therapeutics announced that they have signed an exclusive collaboration and license agreement for the global development and commercialization of OncoArendi's OATD-01. OATD-01 is a Phase 2-ready chitotriosidase/acidic mammalian chitinase inhibitor for the treatment of idiopathic pulmonary fibrosis and other diseases with a fibrotic component. Lung diseases like IPF are associated with an increased chitinase activity, which strongly correlates with disease stage, progression and prognosis. Chitinases, predominantly CHIT1, are involved in macrophage activation. Inhibition of chitinase activity translates into a potential therapeutic benefit, as shown in a range of preclinical models. OATD-01 has shown robust anti-fibrotic activity in multiple animal models, when compared with the standard of care.
BYND MCD

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17:14 EST Beyond Meat says relationship with McDonald's is strong - Beyond Meat (BYND) says seeing velocity increase. Says brand is outpacing category growth. Says experienced meaningful deceleration in Q3 causing lower than expected results. Says near term volatility will likely remain elevated. Says 2020 guidance remains suspended. Says food service remains highly challenged. Says inconsistent consumer buying patterns have continued into Q4. Says relationship with McDonalds (MCD) is strong. Says respects their decision to refer to the McPlant in a generic way. Comments taken from Q3 earnings conference call.
NBIX

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17:08 EST Neurocrine falls 13% to $89.55 after reporting mixed Q3 results
AFMD

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17:04 EST Affimed N.V., Roivant enter licensing, collaboration agreement for Ice molecules - Affimed N.V. and Roivant Sciences announced that they have entered into a licensing and strategic collaboration agreement to develop and commercialize novel Ice molecules in oncology. The collaboration grants Roivant a license to the preclinical molecule AFM32. The collaboration will also leverage Affimed's proprietary Redirected Optimized Cell Killing, or ROCK, platform to generate Ice molecules against targets not included in Affimed's current pipeline. Under the terms of the agreement, Affimed will receive $60M in upfront consideration, comprised of $40M in cash and pre-paid R&D funding, and $20M of newly issued shares in Roivant. Affimed could receive further short-term proceeds in the form of option fees contingent on the commencement of additional programs contemplated under the agreement. The company is eligible to receive up to an additional $2B in milestones over time upon achievement of specified development, regulatory and commercial milestones, as well as tiered royalties on net sales. Pursuant to the agreement, Affimed will be primarily responsible for driving the discovery and research phases of molecule development through filing of the IND. Roivant will be responsible for clinical development and commercialization worldwide, and Affimed retains an option for co-promotion.
SFT

Hot Stocks

17:02 EST Shift announces launch of first region in Texas - Shift announced the launch of its first region in Texas. The company has brought its car-selling service to the Austin used car market. Beginning Monday, Nov. 9, consumers can start selling their cars to Shift directly.
HYMLF...

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17:01 EST Hyundai selects NVIDIA DRIVE platform for future Hyundai, Kia, Genesis models - Nvidia (NVDA) and Hyundai Motor (HYMTF) announced that the automaker's entire lineup of Hyundai, Kia and Genesis models will come standard with NVIDIA DRIVE in-vehicle infotainment systems starting in 2022. From entry-level to premium vehicles, these fleets will feature a rich, software-defined AI user experience that is perpetually updateable. Recent breakthroughs in AI and accelerated computing have opened the door for next-generation cars and trucks to benefit from new functionality, capabilities and enhanced safety features that can be added after the car is purchased. With a centralized, software-defined computing architecture, future vehicles can always have the latest AI cockpit features. Paul Choo, senior vice president of the Electronics Tech Unit at Hyundai Motor Group, said: "At Hyundai Motor Group, we're committed to delivering greater value, safety, functionality and enjoyment over the lifetime of the car. The NVIDIA DRIVE platform is proven - it is scalable, energy-efficient and has the performance to support our next generation of software-defined vehicles."
SIEN

Hot Stocks

17:00 EST Sientra names Ron Menezes CEO, Jeffrey Nugent to retire - Sientra announced that Ron Menezes, former President and General Manager for Almirall , will join Sientra as President and Chief Executive Officer of Sientra, effective November 10. Jeffrey Nugent, the Company's Chairman and Chief Executive Officer since 2015, also announced his retirement from his current responsibilities. He will remain with Sientra through the end of the year in an advisory role to support Mr. Menezes in the transition and to ensure continuity in carrying out the Company's long-term vision. Caroline Van Hove, current Sientra Director, will expand her position on Sientra's Board of Directors and succeed Mr. Nugent as Executive Chair. Mr. Nugent said, "It has been an honor to serve as Chairman and Chief Executive Officer of Sientra over the last five years. In that time, our team has overcome a succession of strategic and executional challenges that, ultimately, made us into a stronger category leader and a more competitive, credible provider and partner to Sientra's core plastic surgery customers. As I look to focus on the other passions in my life, I am excited to work with Ron over the next two months to further position Sientra for long-term success."
NKLA GM

Hot Stocks

16:45 EST Nikola says 'continuing its discussions with General Motors' - On September 8, Nikola (NKLA) announced a strategic partnership agreement with General Motors (GM) which contemplates General Motors receiving equity stake in Nikola in exchange for various in-kind services. The transaction has not closed, and Nikola is continuing its discussions with General Motors. Nikola will provide further updates when appropriate or required.
NKLA

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16:44 EST Nikola says remaining four Nikola Tre prototypes to be finished by year end - During the third quarter, Nikola and IVECO began assembling the first five Nikola Tre BEV prototypes at IVECO's industrial complex in Ulm, Germany, and recently completed the assembly of the first Nikola Tre. The first truck is undergoing systems commissioning, including charging and discharging the high voltage batteries. It has also been put onto the chassis dyno and is undergoing torque command calibration to the e-axles on the test track to prepare for validation testing in the first quarter of 2021. Nikola and IVECO are working diligently to complete the remaining four Nikola Tre prototypes and Nikola anticipates these vehicles will be finished by the end of 2020. The second batch of prototype assembly is expected to begin in the first quarter of 2021.
BYND

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16:43 EST Beyond Meat reports Q3 adj. gross profit $27.3M - Gross profit was $25.5M, or gross margin of 27% of net revenues. Adjusted gross profit was $27.3M, or adjusted gross margin of 28.9% of net revenues, reflecting exclusion of expenses attributable to COVID-19. The company said, "Due to the COVID-19 pandemic, the Company continues to experience a meaningful slowdown in its foodservice business as stay-at-home advisories and restrictions on foodservice locations' operating capacity have resulted in closures or significantly curtailed operations of many of its foodservice customers. At the same time, the surge in demand from retail customers that characterized the early stages of the pandemic as consumers shifted towards more at-home consumption has moderated as panic-buying generally has subsided. This ongoing evolution in consumer demand patterns across retail and foodservice channels has added a higher degree of uncertainty to the Company's ability to forecast demand beyond a limited timeframe. In light of these factors and given the uncertainty regarding the ultimate duration, magnitude and effects of the COVID-19 pandemic, management remains unable to predict the continuing impact of COVID-19 on its business for the balance of the year with reasonable certainty. As such, the Company's 2020 outlook, previously provided on February 27, 2020, remains suspended until further notice."
NKLA

Hot Stocks

16:42 EST Nikola CEO says 'made significant progress on key milestones' in Q3 - "In the third quarter of 2020, Nikola made significant progress on key milestones," said Mark Russell, Nikola's CEO. "We delivered on our commitment to assemble the first Nikola Tre BEV prototypes and are continuing to work with customers on the prospective and previously announced BEV truck orders. I look forward to building on our momentum as we execute our strategy and lay the groundwork to become an integrated zero-emissions transportation solutions leader."
AL

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16:41 EST Air Lease authorizes share buyback of up to $100M - "To successfully emerge from the downturn and prosper in the years beyond, airlines will need new aircraft, like those in our fleet; concurrently, fewer financing options are available to airlines, which presents ALC with additional business opportunities. We believe in our future, and accordingly, our board of directors authorized a share repurchase program of up to $100 million, as well as an increase in our quarterly common stock dividend to $0.16 per share, which represents the 8th increase and 32nd consecutive dividend payment in ALC's history," said Steven F. Udvar-Hazy, Executive Chairman of the Board.
ELY

Hot Stocks

16:41 EST Callaway Golf CEO says 'Q3's trends have thus far continued into Q4' - "The world is embracing golf in a way that has led to a record quarter for the industry and our company," commented Chip Brewer, President and CEO of the company. "Our golf business is now experiencing unprecedented demand and our soft goods business is recovering significantly more quickly than we expected; our third quarter results reflect this momentum. Our recent investments into our e-commerce capabilities have proven particularly valuable, showing strong growth across all of our business segments this year including 108% growth in e-commerce for our apparel brands in Q3." Brewer continued, "Although we expect some level of continued volatility due to the ongoing pandemic, Q3's trends have thus far continued into Q4 and, perhaps more importantly, we also now appreciate even more that all of our businesses are likely to be favored in both the realities of the current world and likely consumer trends post-pandemic. All of our business segments, as well as the Topgolf business, support an outdoor, active and healthy way of life that is compatible with a world of social distancing. These are key factors that will likely be important for consumers over the next several months and will also likely continue post-pandemic."
BT RNG

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16:40 EST RingCentral, BT extend business communications partnership - BT (BT) and RingCentral (RNG) announced an expanded partnership to accelerate the adoption of cloud-based communications and support the digital transformation of businesses across the UK. Cloud Work provided by RingCentral will be a lead Unified Communications as a Service and Contact Center as a Service offering for BT with small, medium and large sized UK enterprises, as well as public sector customers. "As businesses continue to navigate through the complexities of Covid-19, our extended partnership with RingCentral reinforces a commitment and shared vision of bringing innovative communications solutions to our customers so they can thrive now, and put the right building blocks in place for a successful post-pandemic workplace," said Ashish Gupta, Chief Operating Officer, BT's Enterprise Unit. "Every organization is adopting new remote and digital ways of working, with varying degrees of complexity. By collaborating with partners like RingCentral, we're focused on removing this complexity for our customers to enable a successful digital transformation journey." "Today people need to work and collaborate productively from everywhere, and that's what we focus on enabling at RingCentral," said Anand Eswaran, President and Chief Operating Officer, RingCentral. "We're delighted to extend our partnership with BT to make our solution available to a broader set of BT's customers and deliver additional productivity, quality, and cloud economies of scale through tighter integration with BT's leading fixed and wireless network."
HTZGQ

Hot Stocks

16:39 EST Hertz CEO says 'our U.S. Chapter 11 process is progressing well' - "Our U.S. Chapter 11 process is progressing well. Recent, new funding and commitments of more than $6.0 billion allow us to continue taking steps to best position our business as a rental-car and fleet-leasing leader through the pandemic and for the future," said Paul Stone, Hertz Global's President and CEO. In the third quarter, the company made sequential progress as month-to-month revenue improvement, disciplined cost controls and prudent working capital management enabled it to maintain its liquidity position, despite the pandemic challenges impacting the travel sector. "Since Labor Day, U.S. rental volume has trended better, reflecting pent-up leisure demand and market-specific rate adjustments. As a result, our domestic revenue improved 14 points sequentially from July to September. And, October revenue has held steady at September's level," Stone said. Throughout the third quarter, Hertz Global aggressively sold fleet into a record-high U.S. residual market, taking average operating fleet down 34% through its retail, wholesale and dealer-direct channels. As of the end of October, the company's U.S. fleet level is well positioned to match current demand. Hertz Global's average international fleet, down 51% in the third quarter year over year, also is now sized appropriately for the current rental environment. Based on the significant reduction in direct operating and selling, general and administrative expenses to date, the company is increasing its annualized global cost savings target to $3B, up from $2.5B. In addition to the $1.1B in liquidity at September 30, the company recently closed on $1.65B of debtor-in-possession financing which provides support for ongoing operations, vehicle procurement and key investments in the business. The company has also secured commitments for $4B of fleet financing which, if approved by the court, will enable the company to meet its forecasted U.S. fleet needs through 2021. In October, the company closed on a fleet financing facility of up to $400M for its Donlen leasing and fleet management operations.
GVA

Hot Stocks

16:36 EST Granite Construction reports Q3 committed and awarded projects at $4.2B - CEO Kyle Larkin says: "While we can all acknowledge that 2020 has been a difficult year on many fronts, our people will lead the Company through these tough times. Despite the COVID-19 pandemic and California wildfires, our work levels remain steady with minimal project impact, and our business continues to adapt. As of September 30, 2020, total company committed and awarded projects stood at $4.2 billion, and Granite's liquidity has improved over the course of the year. We are focused on completing our restated financials and filing with the SEC so we can once again direct all of our efforts on being the best builders and materials producers in the industry."
MRK

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16:35 EST Merck to discontinue KEYNOTE-598 Phase 3 trial of KEYTRUDA+Yervoy in NSCLC - The company states: "Merck announced that it will be stopping KEYNOTE-598, a Phase 3 trial investigating KEYTRUDA, Merck's anti-PD-1 therapy, in combination with ipilimumab, or Yervoy, compared with KEYTRUDA monotherapy, for the first-line treatment of patients with metastatic non-small cell lung cancer, or NSCLC whose tumors express PD-L1 with no EGFR or ALK genomic tumor aberrations. Merck is discontinuing the study following the recommendation of an independent Data Monitoring Committee, which determined the benefit/risk profile of the combination did not support continuing the trial. At an interim analysis, the combination of KEYTRUDA and ipilimumab showed no incremental benefit in overall survival or progression-free survival, the study's dual primary endpoints, compared with KEYTRUDA alone and crossed futility boundaries. No new safety signals for KEYTRUDA monotherapy were observed, however the combination of KEYTRUDA and ipilimumab was associated with a higher incidence of grade 3-5 adverse events, serious AEs, and AEs leading to discontinuation or death, compared with KEYTRUDA monotherapy. Merck will inform study investigators of the recommendation from the DMC and the DMC is advising that patients in the study discontinue treatment with ipilimumab/placebo. Data from this study will be submitted for presentation at an upcoming scientific congress and communicated to regulatory agencies."
ELTK

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16:33 EST Eltek provides dates and terms of rights offering - Eltek provided the key dates and terms of its rights offering. A registration statement relating to the rights offering has been filed with the SEC and was declared effective today. Under the terms of the rights offering, Eltek is distributing to its holders of ordinary shares as of the record date of November 9, at no charge, one non-transferable subscription rights for each three ordinary shares held or deemed held on the record date. Each right entitles the holder to purchase one ordinary share, at a subscription price of $3.90 per ordinary share. The subscription rights are non-transferable and may only be exercised during the subscription period of November 9, 2020 through 5:00 PM ET on December 2.
CVEO

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16:31 EST Civeo announces 1-for-12 reverse share split - Civeo Corporation announced that its Board of Directors has approved the implementation of a 1-for-12 reverse share split of the Company's common shares. The Company's shareholders previously approved a proposal authorizing the Board of Directors to implement the reverse share split at the 2020 annual meeting. The 1-for-12 reverse share split will be effective as of 5:00 p.m. Eastern Time on November 19, 2020, and the Company's Common Shares will begin trading on a split-adjusted basis at the market opening on November 20, 2020. Civeo's Common Shares will continue to trade on the NYSE under the symbol "CVEO."
BBDC

Hot Stocks

16:29 EST Barings BDC raises dividend to 17c from 16c - Barings BDC announced that the Company's Board of Directors declared a quarterly cash dividend of 17c per share. Eric Lloyd, CEO, stated, "I am pleased to announce that the Barings BDC Board of Directors approved a dividend increase to 17c per share for the Q4, up from 16c per share in the Q3."
ARNA

Hot Stocks

16:26 EST Arena Pharmaceuticals advancing etrasimod Into Phase 3 program - Arena Pharmaceuticals announced topline results from the Phase 2b ADVISE clinical trial evaluating etrasimod, a highly selective, once-daily, oral sphingosine 1-phosphate receptor modulator, for the treatment of moderate-to-severe atopic dermatitis. "Today is an important day for Arena as we achieved our key objectives for the ADVISE trial which were to evaluate safety and efficacy of etrasimod in a dermatologic population, and to inform dose and design decisions for a pivotal Phase 3 program. We believe the clinical benefits of etrasimod in this trial were impressive, especially given the challenges of conducting a Phase 2 trial with a novel MOA in atopic dermatitis," stated Chris Cabell, MD, MHS, FACC, Executive Vice President, Head of Research and Development, and Chief Medical Officer at Arena. "We look forward to advancing etrasimod into a Phase 3 program in atopic dermatitis. We would like to thank the patients, trial coordinators and investigators who participated in this important trial." In the ADVISE trial, the participants were representative of a moderate patient population (82.9% baseline vIGA 3) which constitutes upward of 40% of the AD market1. In the primary analysis, nearly one-third of participants in the 2 mg etrasimod group achieved clear or almost clear skin, as defined by the validated Investigator Global Assessment- the FDA endpoint for Phase 3 registration. Importantly, the vIGA improvement was statistically significant vs. placebo at 12 weeks. Across the Eczema Area and Severity Index, EASI-75 and peak change in pruritis, etrasimod 2 mg demonstrated early and statistically significant effect at week 4. Etrasimod did not meet the Ph 2b primary endpoint of EASI change from baseline at week 12 as compared to placebo. Overall, the 12-week study showed no plateau of effect, and the safety profile was consistent with previous trials of etrasimod including low first dose heart rate effect with no titration, and no serious adverse events across the groups. In the etrasimod groups, there were no cases of venous thromboembolic events, opportunistic or serious infections, macular edema, conjunctivitis, acne or herpes zoster. Additionally, none of the other adverse events commonly associated with first-generation S1P receptor modulators were seen in this trial. Between weeks 4-8, the trial was impacted by unwarranted dose interruption (not related to drug safety) in 19% of the etrasimod 2 mg group. Adjusting for this dose interruption - a post-hoc Completer Analysis with participants receiving full therapeutic exposure - etrasimod 2 mg showed statistically significant effect on the EASI score compared to placebo (weeks 4 and 12), EASI-75 at week 4, vIGA at week 12 and pruritis through week 8. Importantly, the analysis of the participant cohort with dose interruption showed diminished clinical effect upon withdrawal and a recapture of effect upon reinstatement of study drug consistent with the pharmacodynamics of etrasimod. Based on the compelling profile in this moderate AD population, etrasimod will be proceeding into a Phase 3 registrational program.
NCLH

Hot Stocks

16:26 EST Norwegian Cruise Line says continues to be demand for future cruise vacations - The company said, "While booking volumes since the emergence of the COVID-19 global pandemic remain below historical levels, there continues to be demand for future cruise vacations, particularly beginning for sailings operating in the second half of 2021 and beyond, despite limited marketing efforts. Our overall cumulative booked position for the first half of 2021 remains below historical ranges as expected due to the current uncertain environment, however, for the second half of 2021 it is in line with historical ranges. Pricing for full year 2021 is in line with pre-pandemic levels, even after including the dilutive impact of future cruise credits. Pent up future demand for cruising is further demonstrated by record booking achievements in September and October including Oceania Cruises' Labor Day upgrade sale which was the most successful holiday promotion in the line's history, a new World Cruise opening day booking record for Regent Seven Seas Cruises' 2023 World Cruise and a new all-time largest single booking day in Regent's history with the launch of its 2022-2023 Voyage Collection. To provide additional flexibility to its guests, the Company has also extended its modified final payment schedule for all voyages through April 30, 2021 which requires final payment 60 days prior to embarkation versus the standard 120 days. As of September 30, 2020, the Company had $1.2 billion of advance ticket sales, including the long-term portion of advance ticket sales, which includes approximately $0.85 billion of future cruise credits."
XPER...

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16:24 EST Xperi, Comcast enter into long-term patent license agreement - TiVo, a subsidiary of Xperi (XPER), and Comcast (CMCSA) announed that they have entered into a 15-year patent license agreement. The agreement is effective as of the expiration of Comcast's prior agreement in 2016, providing broad coverage under TiVo's patent portfolios into 2031. The agreement also resolves all of the outstanding litigation between the companies. The terms of the agreement are consistent with TiVo's well-established licensing program for the Pay-TV market. The agreement provides for an initial payment upon execution and ongoing payments through the remainder of the agreement.
ARNA

Hot Stocks

16:24 EST Arena sees FY20 cash used in operating activitires $345M-$355M - Cash used in operating activities for the FY20 is expected to be $345M-$355M, down compared to our previous guidance of $400M-$430M. Arena continues to achieve key milestones while 2020 full-year operating expenses decrease due to clinical trial efficiency and continued focus on optimizing spend
FCPT

Hot Stocks

16:23 EST Four Corners Property Trust raises quarterly dividend by 4.1% to 31.75c / share - The dividend is payable on January 15, 2021 to shareholders of record as of January 4, 2021.
OXY

Hot Stocks

16:23 EST Occidental Petroleum sees Q4 production 5% below Q3 - The company sees Q4 production of ~1,160 Mboed, or 5% below Q3.
FITB

Hot Stocks

16:21 EST Fifth Third names Jamie Leonard CFO - Fifth Third Bancorp announced the appointment of Jamie Leonard as chief financial officer, effective immediately. The company also announced the appointment of Bob Shaffer as chief risk officer, to succeed Leonard, and Peg Jula as chief human resources officer, succeeding Shaffer. "Jamie has played a critical role in our risk management and treasury activities, and we are fortunate to have someone with his experience and skills who can seamlessly step into the chief financial officer role at Fifth Third," said Greg D. Carmichael, Fifth Third's chairman and chief executive officer. "Jamie's vast knowledge of our financial performance is unrivaled, as is his astute ability to identify and manage risk. These attributes will continue to serve our shareholders, customers, employees and communities extremely well."
SPG

Hot Stocks

16:20 EST Simon Property says all U.S. retail properties currently open - David Simon, Chairman, CEO and President, said: "I am pleased with the solid profitability and substantial improvement in cash flow from operations we generated in the third quarter. As we continue to navigate through the pandemic and the resulting economic conditions, the well-being of our employees, shoppers and communities we serve remains at the forefront. Despite COVID-19, we are encouraged by the increases we are seeing in shopper traffic, retailer sales and tenant rent collections across our portfolio. We continue to improve our company through innovative investment opportunities which, when combined with our A-rated balance sheet, sets us apart and allows us to re-define the future." The company added: "All of the company's U.S. retail properties are currently open, welcoming shoppers to this year's extended holiday shopping season. During the quarter, seven retail properties in California were temporarily closed on July 15 due to a restrictive governmental order. Six of the properties reopened August 31 and the seventh reopened on October 7, after the easing of governmental restrictions in Los Angeles. As of November 6, 2020, the company has collected from its U.S. retail portfolio, 72% of its net billed rents for the second quarter. Further, the company has realized higher net billed rent collections for the third quarter, with a collection rate of 85% as of November 6, 2020."
ADBE

Hot Stocks

16:18 EST Adobe to acquire Workfront for $1.5B - Adobe announced it has entered into a definitive agreement to acquire Workfront, the "leading work management platform for marketers", for $1.5B, subject to customary purchase price adjustments. The company states: "Workfront has deep leadership in orchestrating marketing workflows. Workfront's platform is agile and uniquely architected for the enterprise, with extensive integration capabilities that can be easily configured to meet the varied needs of companies of all sizes. Adobe and Workfront are longstanding partners with strong product synergies and a growing base of over 1,000 shared customers. Workfront is equipped with APIs that enable a seamless connection to Adobe Creative Cloud and Adobe Experience Cloud. Shared Adobe and Workfront customers include Deloitte, Under Armour, Nordstrom, Prudential Financial, T-Mobile, and The Home Depot. Upon close, Workfront CEO Alex Shootman will continue to lead the Workfront team, reporting to Anil Chakravarthy, executive vice president and general manager, Digital Experience Business and Worldwide Field Operations. The transaction, which is expected to close during the first quarter of Adobe's 2021 fiscal year, is subject to regulatory approval and customary closing conditions. Until the transaction closes, each company will continue to operate independently."
WES

Hot Stocks

16:17 EST Western Midstream sees FY21 CapEx $275M-$375M
VUZI

Hot Stocks

16:16 EST Vuzix expects to deliver continued smart glasses revenue growth in Q4 - "The COVID-19 Pandemic has become a catalyst for much broader acceptance of enterprise smart glasses, resulting in shorter evaluation periods and increased customer adoption," said the company. "The healthcare, field service and manufacturing sectors, which were all important growth contributors in our third quarter, continue to show strength and we expect these segments to remain robust growth drivers for the Company over the remainder of 2020 and beyond. To this point, our Q4 is off to a great start with October sales of smart glasses being the highest single month of such sales we've ever recorded. As a result, today we believe we are in a strong position to deliver continued smart glasses revenue growth in our Q4. We are equally optimistic about our OEM and Engineering Services business as we are now working on deliverables against five active programs. These programs collectively represent more than $700,000 of contractual commitments, a substantial portion of which we expect to realize as revenue during our Q4. Additionally, we anticipate advancing some of these programs towards supply and production agreements of our customized waveguide-based HMDs and HD display engine products in the near future".
WES

Hot Stocks

16:16 EST Western Midstream sees FY21 adjusted EBITDA $1.825B-$1.925B
WES

Hot Stocks

16:16 EST Western Midstream announces $250M buyback program - The board of directors of the Partnership's general partner has authorized the Partnership to commence a buyback program of up to $250M of the Partnership's common units through December 31, 2021.
SSTI

Hot Stocks

16:16 EST ShotSpotter acquires CrimeCenter Software for $22M in cash, stock - ShotSpotter announced it has signed a definitive agreement to acquire Leeds, doing business as CrimeCenter Software. The acquisition will expand ShotSpotter's suite of law enforcement solutions with the CrimeCenter line of investigative case management software. Leeds' primary business is supplying a major metropolitan police department on the East Coast with CrimeCenter and a variety of IT-related professional services. Leeds has more than 30 employees and is based in Newark, New Jersey. Under the terms of the agreement, ShotSpotter will pay approximately $22 million in cash and stock, which includes a potential earnout of up to $5 million. The deal is expected to close in November and is subject to customary closing conditions. Upon closing, Leeds will become a wholly owned subsidiary of ShotSpotter. With the addition of CrimeCenter to its product lineup of patrol management and gunshot detection solutions, ShotSpotter will offer the only complete precision policing platform to enable intelligence-driven prevention, response to, and investigation of crime for local, state and federal agencies. The newly expanded ShotSpotter platform is expected to increase the company's total addressable market for law enforcement software in just the U.S. by more than 45 percent. "CrimeCenter is a perfect fit with our strategy to offer an integrated set of precision policing solutions to help drive down crime," said Ralph A. Clark, CEO and President of ShotSpotter. "Case management is a proven category, as every agency is required to document and investigate crimes and identify and arrest suspects. The CrimeCenter solution does it in a new and better way. We see it opening up new business opportunities beyond municipal law enforcement, including state and federal agencies."
RVNC

Hot Stocks

16:15 EST Revance's phase 2 trial for Daxibotulin does not meet primary efficacy endpoint - Revance Therapeutics announced results from its Phase 2 clinical trial of investigational drug candidate DaxibotulinumtoxinA for Injection for the management of plantar fasciitis. This Phase 2 prospective, randomized, double-blind, multi-center, placebo-controlled trial evaluated the safety and efficacy of two doses of DaxibotulinumtoxinA for Injection in reducing the signs and symptoms of plantar fasciitis. The trial enrolled 155 adult patients with unilateral plantar fasciitis, 18 to 65 years of age, at 17 study centers in the United States. Patients were randomized (1:1:1) to receive an injection of DAXI 80 U, DAXI 120 U or placebo. The study's primary efficacy endpoint was the change from baseline on the 10-point Numeric Pain Rating Scale score averaged over five days at Week 8. Patients were followed for up to 24 weeks post treatment to assess treatment response, tolerability and safety. In the trial, both doses of DaxibotulinumtoxinA for Injection resulted in significant, measurable pain relief after treatment that was numerically greater than placebo. However, neither dose met the primary efficacy endpoint of statistically significant improvement from baseline in the NPRS for foot pain at Week 8, compared to placebo. Subjects treated with DaxibotulinumtoxinA for Injection showed an average reduction from baseline of 3.29 on the NPRS (a 54.6% reduction) at 80U (p=0.2135 vs. placebo) and 3.25 on the NPRS (a 50.1% reduction) at 120U (p=0.2205 vs. placebo, p=0.9207 vs. 80U), compared to placebo subjects at 2.75 on the NPRS (a 45.1% reduction).
RAMP

Hot Stocks

16:15 EST LiveRamp extends share repurchase program through December 31, 2022 - LiveRamp announced that its board of directors authorized the extension of its share repurchase program through December 31, 2022. The company had approximately $326M of remaining capacity available under the program as of September 30, 2020. Under the program, LiveRamp is authorized to repurchase outstanding shares in open market or privately negotiated transactions depending on prevailing market conditions and other factors.
RVNC

Hot Stocks

16:13 EST Revance sees FY20 operating expenses $220M-$230M - The company states: "Revance expects GAAP operating expense to be $285 to $295 million and non-GAAP operating expense, which excludes costs of revenue, depreciation and amortization, stock-based compensation, and non-cash in-process research and development costs, to be in the range of $220 to $230 million. With multiple clinical programs underway, along with regulatory and pre-commercial manufacturing activities, Revance anticipates 2020 non-GAAP, non-HintMD related research and development expense to be $95 to $100 million. With current cash and equivalents, management projects that the company is funded into 2023."
RVNC

Hot Stocks

16:12 EST Revance reports Q3 EPS ($1.34), consensus ($1.03) - Reports Q3 revenue $3.8M, consensus $1.8M. CEO Mark Foley says: "The third quarter of 2020 marked a significant milestone in the company's history as Revance successfully transitioned to a fully integrated commercial enterprise. I am very pleased with the positive, early market feedback on our RHA(R) Collection of dermal fillers and HintMD fintech platform. We have assembled a portfolio of differentiated and unique assets for our aesthetics franchise and we believe we have the right commercial team and strategy for success."
SCOR

Hot Stocks

16:11 EST Comscore in 'advanced discussions' with investor regarding recapitalization - Comscore provided an update regarding its review of strategic alternatives announced last year. Comscore's board of directors and management, supported by its legal and financial advisors, have conducted a thorough and deliberate review process. Comscore confirmed that it is in advanced discussions with respect to a recapitalization transaction with an anchor investor. The transaction, if consummated, would result in a significant reduction in Comscore's outstanding indebtedness, enhancing its balance sheet and liquidity profile. In addition, the transaction would provide for enhanced commercial relationships to support Comscore's growth initiatives. Comscore and the other relevant parties are working to conclude negotiations. However, there can be no assurances regarding the timing of any action or transaction nor that the strategic review process will result in any particular outcome, including the transaction described above. The company does not intend to provide additional updates unless or until it determines that further disclosure is necessary.
AVEO

Hot Stocks

16:10 EST Aveo Pharmaceuticals sees funding for operations into 2022 - Aveo Pharmaceuticals believes that its $68.8M in cash, cash equivalents and marketable securities as of September 30, "along with anticipated partnership cost sharing reimbursements, royalties from EUSA's FOTIVDA sales and, if the pending marketing application for FOTIVDA is approved by the FDA, resulting product revenues upon commercial launch and the potential additional $20 million in credit under the Hercules loan, would allow the Company to fund planned operations into 2022."
NVAX

Hot Stocks

16:09 EST Novavax appoints Gregory Covino CFO - Novavax announced updates to its leadership team, including the appointment of Gregory Covino as executive VP and CFO. Executive VP John Trizzino, who previously served as CFO, will now become the Chief Commercial Officer while continuing in his role as Chief Business Officer.
NBIX

Hot Stocks

16:07 EST Neurocrine sees FY20 combined GAAP R&D and SG&A expenses $880M-$900M - Sees FY20 combined Non-GAAP R&D and SG&A expenses $590M-$610M. Previously, the Company expected combined GAAP R&D and SG&A expenses in the range of $850M-$900M and combined non-GAAP R&D and SG&A expenses in the range of $570M-$610M.
AVD

Hot Stocks

16:05 EST American Vanguard CEO 'encouraged' by prospects for Q4 - Eric Wintemute, Chairman and CEO of American Vanguard commented, "Based upon these trends and current sales activity, barring unforeseen weather or pandemic factors, we are encouraged by our prospects for the fourth quarter and into the 2021 season. While endeavoring to maximize our financial performance, we continue to pursue strategic initiatives in technology development, portfolio expansion and market access. Please listen in to our upcoming earnings call during which I will be devoting my time to our three-to-five-year outlook with a particular focus on new product development, our growing portfolio of green products and our SIMPAS prescription application technology."
ETM

Hot Stocks

16:02 EST Entercom acquires iGaming affiliate platform QL Gaming Group for $32M - Entercom Communications announced it has closed on the acquisition of sports data and iGaming affiliate platform QL Gaming Group in an all cash deal for approximately $32M. The acquisition brings unrivaled data, analytics and insight-driven content to Entercom's best-in-class sports broadcast stations, influential podcasts and RADIO.COM, the fastest growing digital audio platform in America. The QLGG technology portfolio includes sports betting data and analytical capabilities , daily fantasy sports, simulation-based sports outcome predictions and game forecasting, and comprehensive analytical coverage of the ATP and WTA Tours, each with respective subscriber base and licensing opportunities.
MRNS

Hot Stocks

15:59 EST Marinus Pharmaceuticals names Christy Shafer chief commercial officer - Marinus Pharmaceuticals announced that Christy Shafer has been appointed Chief Commercial Officer, reporting to Scott Braunstein, M.D., Chief Executive Officer of Marinus. "As we continue to build our senior team with formidable leaders, we believe Christy is the right person to drive our commercial strategy, and to prepare the company for its potential first launch of ganaxolone in the area of CDKL5 deficiency disorder," said Scott Braunstein M.D., Chief Executive Officer of Marinus. "With her combined rare disease and hospital directed expertise, Christy will provide pivotal leadership in steering our commercial strategy and execution." Ms. Shafer has spent almost 20 years in the biotech, pharma, and medical device spaces, with her most recent position being Business Director of Neurology at Alexion Pharmaceuticals.
GRA

Hot Stocks

15:28 EST W.R. Grace: 40 North's $60/share proposal 'significantly undervalues' company - W. R. Grace & Co. confirmed that it has received a proposal from 40 North Management, one of its shareholders, to acquire all outstanding common shares of the company for $60 per share in cash, subject to certain conditions. Grace has a portfolio of high-value, specialty businesses and while end markets have been significantly impacted by the pandemic, the fundamentals of its businesses remain strong and demand trends continue to improve. As the company has communicated, most recently on its third quarter 2020 earnings call, Grace has often pursued opportunities to maximize shareholder value. Consistent with its commitment to all shareholders, Grace's Board, working with management and its financial advisers, is carefully evaluating and thoroughly discussing its value creation opportunities. At the same time, Grace is focused on executing its long-term strategy and advancing its key investments to accelerate profitable growth, improve its competitive advantages and strengthen its portfolio. Given the company's strong prospects and its ongoing review of the alternative opportunities available, Grace's Board of Directors unanimously believes that 40 North's $60 per share proposal significantly undervalues the company and is not a basis for further discussion. The Grace Board remains open to all opportunities to maximize value for shareholders.
IVZ JHG

Hot Stocks

15:22 EST Peltz 'thrilled' to be on Invesco board, 'didn't say' it should merge with Janus - Asked whether he is pushing for Invesco (IVZ) to merge with Janus Henderson (JHG), Nelson Peltz answered "I didn't say that," adding that he hopes Invesco will be a leader as the sector consolidates, as he thinks it should. Speculation has mounted about a tie-up between Invesco and Janus since Trian Fund Management took stakes of nearly 10% in each company in October. Nelson Peltz, CEO of Trian Partners, made the comments while being interviewed on CNBC.
AUVI

Hot Stocks

15:22 EST Applied UV signs non-binging LOI to acquire Airocide System - Applied UV announced that in addition to its exclusive Joint Distribution and Licensing Agreement with Akida Holdings that was announced in a press release on September 8, it has signed a non-binding letter of intent to explore the possibility of acquiring certain key assets of Akida, including Akida's rights to the manufacture and sale of the Airocide System of patented, air purification technologies, which may aid in the reopening of the global economy with applications in the hospitality, hotel, healthcare, nursing homes, grocer, wine, commercial buildings and retail sectors, for up to a maximum of $12M, subject to Akida Holdings obtaining significant EBITDA increases over the next two years, along with a clawback and a two year lockup of restricted Applied UV stock. Akida has agreed to cooperate with Applied UV's due diligence process and not actively pursue parallel alternative sale or financing alternatives until the earlier of the execution of a definitive agreement and March 2, 2021.
ADAP

Hot Stocks

15:22 EST Adaptimmune says SURPASS data support continued development of ADP-A2M4CD8 - Adaptimmune Therapeutics presented data from the dose escalation cohorts of its Phase 1 SURPASS trial using ADP-A2M4CD8 in a poster at the Society for the Immunotherapy of Cancer Conference. In these cohorts of heavily pre-treated patients with advanced cancers, three were treated with target doses of 1 billion SPEAR T-cells, and three with target doses of 5 billion. Most adverse events were consistent with those typically experienced by cancer patients undergoing cytotoxic chemotherapy or cancer immunotherapy. "We have seen responses in two out of six patients treated in the safety cohorts of the SURPASS trial as well as antitumor activity in five of them. The responses and antitumor activity we have seen with our next-generation ADP-A2M4CD8 SPEAR T-cells, across a range of solid tumors, support our belief that this is a highly active product," said Ad Rawcliffe, Adaptimmune's Chief Executive Officer. "Based on these data, we will initiate the Phase 2 trial in gastroesophageal cancers in the first half of 2021 and look forward to identifying additional indications to take into late-stage development." There were two confirmed partial responses: one in a patient with esophagogastric junction cancer, previously reported, and one in a patient with head and neck cancer, reported as unconfirmed in May. The four other patients had best overall responses of stable disease. Overall, five out of six patients treated had initial tumor shrinkage. In vitro translational data using the manufactured products from patients in the SURPASS trial indicate that co-expression of the CD8alpha co-receptor on CD4+ ADP-A2M4 SPEAR T-cells enables them to kill MAGE-A4 expressing target cells with equal potency as CD8+ SPEAR T-cells targeting MAGE-A4. These data, combined with the responses and antitumor activity observed at low doses, indicate that ADPA2M4D8 may be a more potent product than the first-generation ADPA2M4 SPEAR T-cells.
CMCSA

Hot Stocks

15:18 EST Peltz says having 'constructive discussions' with management at Comcast - Nelson Peltz, CEO of Trian Partners, said while being interviewed on CNBC that his fund and management at Comcast are having "constructive discussions" and he will leave it at that for now as to not "muddy the waters" while talks are ongoing.
VREOF

Hot Stocks

15:13 EST Vireo Health secures $1.3M purchase option to expand capabilities in New York - Vireo Health announced that it has secured a purchase option that would enable the company to expand its cultivation and processing operations adjacent to the Vireo Bluebird Facility in Fulton County, New York. This purchase option agreement provides Vireo with the optionality to expand its cultivation and manufacturing capabilities in the state of New York. The option allows Vireo the flexibility to add up to an additional 96 acres of land adjacent to its existing facilities for a total purchase price of approximately $1.3M. "In 2015, Vireo was proud to harvest New York's first legal cannabis crop in over 100 years. Since then, Vireo has helped more than 20,000 New Yorkers receive safe and effective treatment with medical cannabis," said chairman and CEO, Kyle Kingsley. "With the potential for regulatory changes in the New York cannabis program in 2021, this option to expand our facility with 96 additional acres should create a major opportunity for Vireo in New York, which would immediately become one of the largest adult-use markets in the country."
BYND MCD

Hot Stocks

14:37 EST Beyond Meat confirms to The Fly co-creation of McDonald's 'McPlant' burger - Contacted by The Fly, a Beyond Meat (BYND) spokesperson said that the company and McDonald's (MCD) "co-created the plant-based patty, which will be available as part of their McPlant platform."
IZEA

Hot Stocks

14:01 EST IZEA awarded 'mid six-figure' contract with U.S. military branch - IZEA Worldwide announced that it has secured a mid six-figure contract with a branch of the U.S. military. The contract represents the largest award IZEA has received from a federal agency to date, following a string of successful influencer marketing campaigns for a variety of state and local government agencies. Earlier this year IZEA was awarded a campaign by the Commonwealth of Kentucky to drive awareness and education about the benefits of wearing a mask to reduce the spread of COVID-19. IZEA utilized influencers to combat common misperceptions about masks as well as address and overcome the ideological positions put forth by those who oppose wearing masks, an ongoing challenge for states across the country. "We are excited to see our federal government more aggressively investing in influencer marketing. It is a clear sign that influencer marketing is now mainstream and a key component of any marketing strategy," said Ted Murphy, IZEA's Chairman and CEO. "Our team is proud to support efforts to raise awareness for the military and we look forward to launching this initiative to educate and inform the public."
SYK

Hot Stocks

14:00 EST FDA identifies Stryker Neurovascular recall of Trevo retriever as Class I - Stryker Neurovascular is recalling the Trevo XP ProVue Retriever device because there is a risk the core wire may break or separate when the core wire is retracted during use, the FDA reported. If this occurs, the device could be left inside the patient's blood vessel or tissue. There have been 11 reports of injury or illness related to this device issue and one death, according to a post to the FDA website that lists the date the recall was initiated as September 21, 2020. "The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death," the FDA said. Reference Link
AXAS

Hot Stocks

14:00 EST Abraxas Petroleum regains compliance with Nasdaq continued listing standards - Abraxas Petroleum Corporation announced that on November 2, 2020 it received a confirmation letter from The NASDAQ Stock Market LLC that it has regained compliance with Nasdaq Listing Rule 5550(a)(2), which requires a minimum average closing price of $1.00 per share over a period of 10 consecutive trading days. The letter also confirms that Nasdaq is closing the non-compliance matter.
TXT

Hot Stocks

13:23 EST Textron trading resumes
TXT

Hot Stocks

13:09 EST Textron calls purported Xcalibur tender offer 'fictious' - Textron responded to a purported tender offer by Xcalibur Aerospace to acquire Textron's common stock. The company said, "Textron believes that the purported tender offer is fictitious and is being made in violation of U.S. securities laws, including relevant filing and disclosure requirements. Textron further notes that in the past two years Textron has received other purported indications of interest from Xcalibur, and each time Xcalibur has been unable to provide details of its financial wherewithal. As it has done previously, Textron has informed relevant authorities of this most recent fictitious offer. We urge investors to carefully scrutinize any communications from the purported offeror and to rely only on tender offer materials, if any, that are properly filed with the U.S. Securities and Exchange Commission. Unless and until a valid tender offer is made, Textron does not expect to comment further regarding the actions of the purported offeror. "
HUM

Hot Stocks

13:01 EST Northwell Health, Humana renew NY health care agreement - Northwell Health and Humana announced a five-year agreement that will bring new products and services to the community to improve health care in the New York metropolitan area. The agreement allows Northwell and Humana to work collaboratively to offer a Northwell retiree product for 2021 and look forward to collaborating on products in the future. Northwell and Humana will build upon successful clinical initiatives such as expanding Northwell's House Calls program, integrated with the health system's clinical call center and community paramedic services. "We're continuing to work to transform health care delivery for our most vulnerable home bound seniors by bringing critical services to the patient's home, while substantially reducing ER visits, admissions and costs," said Michael Dowling, President and CEO of Northwell Health.
TXT

Hot Stocks

12:43 EST Textron trading halted, news pending
CG VFC

Hot Stocks

12:23 EST VF acquires streetwear brand Supreme for base price of $2.1B - VF Corporation (VFC) and streetwear brand Supreme jointly announced earlier today that they have signed a definitive merger agreement. Current investors, The Carlyle Group (CG) and Goode Partners, are selling their stakes in the Supreme brand. Upon the terms and subject to the conditions, VF has agreed to pay an aggregate base purchase price of $2.1B and, subject to satisfaction of certain post-closing milestones, an additional payment of up to $300M. The Supreme brand is expected to be "modestly accretive" to VF's revenue and adjusted earnings in fiscal 2021. The brand is expected to contribute at least $500M of revenue and 20c of adjusted earnings per share in fiscal 2022.
GM

Hot Stocks

12:02 EST General Motors to add 3,000 engineers in electric vehicle push - Now through the first quarter of 2021, General Motors will hire 3,000 new employees across engineering, design and IT to help transform the future of product development and software as a service. GM will offer more remote opportunities than ever before as development of autonomous and electric vehicles and advanced platforms like the Ultium battery system continue at a fast pace. Recent virtual development innovations made by the company's engineering team have allowed GM to speed up the product timelines of upcoming EVs while keeping costs low. "As we evolve and grow our software expertise and services, it's important that we continue to recruit and add diverse talent," said GM President Mark Reuss. "This will clearly show that we're committed to further developing the software we need to lead in EVs, enhance the customer experience and become a software expertise-driven workforce." GM plans to advance its vision of zero crashes, zero emissions, zero congestion through the development and integration of its world-class software and services. Job openings for electrical system engineers; infotainment software engineers; developers for Java, Android, iOS and other platforms; controls engineers; and more will help to build on GM's current software foundation.
GM

Hot Stocks

12:02 EST General Motors to add 3,000 engineers in electric vehicle push
UNFI

Hot Stocks

12:01 EST United Natural Foods reaches labor agreements in New York, California - United Natural Foods announced that it has reached new long-term labor agreements with drivers at its Hudson Valley distribution center in Montgomery, New York and front-line workers in California at its distribution centers in Commerce, Stockton and Santa Fe Springs. UNFI associates in the Hudson Valley are represented by Teamsters Local 445 and those in Southern California are represented by Teamsters Locals 495, 630, 848 and 439. The new contracts include compromises and language updates that provide UNFI important operating flexibility to better serve its customers while providing its valued associates highly competitive wages, strong benefits and industry-leading safety and risk management support amidst the COVID-19 pandemic. Eric Dorne, UNFI's COO, commented: "We're pleased to fortify our distribution network and strengthen the nation's food supply chain ahead of the busy holiday season and winter months. Our new long-term labor agreements in the Hudson Valley and southern California put us on strong footing in the near-term and provide us with valuable flexibility to best serve our customers over the long-term. These are the foundational elements of the exceptional customer service we intend to deliver across the Pacific and Northeast regions in the years ahead. I also want to take this opportunity to thank all of our associates, partners and customers throughout the country for their collaboration and confidence amidst the pandemic."
NLS

Hot Stocks

12:00 EST Nautilus falls -18.9% - Nautilus is down -18.9%, or -$5.25 to $22.55.
FAZ

Hot Stocks

12:00 EST Direxion Financial Bear 3x falls -20.9% - Direxion Financial Bear 3x is down -20.9%, or -$2.67 to $10.08.
VAPO

Hot Stocks

12:00 EST Vapotherm falls -24.0% - Vapotherm is down -24.0%, or -$6.64 to $21.04.
VVI

Hot Stocks

12:00 EST Viad rises 37.8% - Viad is up 37.8%, or $7.10 to $25.90.
CNK

Hot Stocks

12:00 EST Cinemark rises 52.5% - Cinemark is up 52.5%, or $4.73 to $13.74.
AMC

Hot Stocks

12:00 EST AMC Entertainment rises 68.4% - AMC Entertainment is up 68.4%, or $1.70 to $4.19.
GRFS

Hot Stocks

12:00 EST Grifols acquires remaining 49% of Goetech for $60.2M - Grifols announced the acquisition of the remaining 49% share of Goetech, whose trade name is MedKeeper, in exchange for a total price of $60.2M. No additional financing will be required, the company said. Since 2018, Grifols has owned a 51% equity stake of the U.S.-based technology firm. Grifols s added that it continues to move forward "with its strategic plans to drive long-term sustainable growth in all of its divisions." It noted, "In the case of the Hospital Division, MedKeeper's attributes complement and strengthen Pharmatech, its core business line. The transaction also boosts the division's international expansion and footprint in the U.S. market."
PFE BNTX

Hot Stocks

11:50 EST EU plans to sign supply deal for up to 300M doses of Pfizer COVID-19 vaccine - European Commission president Ursula von der Leyen said that the commission intends to sign a contract with Pfizer (PFE) and BioNTech (BNTX) soon for up to 300M doses of its COVID-19 vaccine candidate following the "successful results" of the vaccine's latest clinical trial. "Let's keep protecting each other in the meantime," von der Leyen said via Twitter. Reference Link
MCD

Hot Stocks

11:32 EST McDonald's plans to open about 1,300 restaurants in 2021
MCD

Hot Stocks

11:32 EST McDonald's : Average U.S. check still up in teens percentage
LORL

Hot Stocks

11:11 EST Telesat, Government of Canada finalize C$600M agreement - Telesat and the Government of Canada announced the completion of their agreement to ensure affordable, high-speed broadband connectivity across all of Canada with Telesat's advanced, state-of-the-art Low Earth Orbit satellite constellation. Following a Memorandum of Understanding signed in July 2019, this C$600M agreement enables Internet and mobility service providers to acquire Telesat LEO capacity at substantially reduced rates to bring universal broadband connectivity to rural, Northern and Indigenous communities across Canada. Telesat will be eligible to receive amounts under the agreement over a ten year period once the Telesat LEO constellation enters service. Under the terms of the agreement, a dedicated pool of Telesat LEO rural connectivity capacity will be available to Service Providers at greatly reduced rates on a first come, first served basis to provide connectivity for eligible communities. With Telesat LEO's high performance network capacity, service providers will offer broadband services to their end users of at least 50/10 Mbps speeds with unlimited data, and mobility service providers will offer LTE services.
LEGN

Hot Stocks

11:09 EST Legend Biotech appoints Ying Huang as CEO - Legend Biotech Corporation announced that Ye Wang was appointed, effective November 6, 2020, as Chairwoman of the Board of Directors of Legend Biotech. The Board of Directors also named Dr. Ying Huang as CEO of Legend Biotech, effective November 6, 2020. Dr. Huang had been serving as interim CEO since September 21, 2020. Dr. Huang will continue to hold his position of Chief Financial Officer until such time as a successor CFO is identified.
SPNS

Hot Stocks

11:08 EST Sapiens acquires Tia Technology, terms not disclosed - Sapiens International Corporation announced that it has entered into a definitive agreement to acquire Tia Technology, a vendor of digital software solutions, from the global investment organization EQT Mid Market. The transaction is subject to customary closing conditions and is expected to be completed by end of this month. Headquartered in Denmark, Tia Technology has over 20 years of experience and nearly 70 customers globally, primarily in Denmark, Norway, Sweden, Finland, South Africa and the Baltics. The company offers comprehensive software solutions primarily for Property & Casualty insurers as well as Life and Pension, Health, and sfeveral innovative extension modules. Additionally, Tia offers a full scope of expert implementation, application management and hosting services, enabling insurers to execute their digital and business strategies. Sapiens will continue to develop and support Tia's products and serve its customers, who can now benefit from Sapiens' variety of offerings. In addition, Sapiens will leverage the insurance domain knowledge of Tia's 200 employees to further expand Sapiens P&C and L&P offerings in their respective regions in which it operates. Tia's 2019 full-year revenue was $30M with 14% non-GAAP normalized operational profit margin. The total consideration is $78M in cash on a fully diluted basis. At closing, Sapiens will hold no less than 95% of the company's shares and will have the right to acquire the remaining minority shares. The transaction is expected to be accretive to Sapiens from closing.
MCD

Hot Stocks

11:06 EST McDonald's sees 2021 free cash flow approaching 2019 levels
APVO

Hot Stocks

11:04 EST Aptevo Therapeutics adopts rights agreement - In a regulatory filing earlier, Aptevo Therapeutics disclosed that on November 8, the Board of Directors of the company approved and adopted a Rights Agreement, dated as of November 8 and the Board declared a dividend of one preferred share purchase right for each outstanding share of common stock of the company. The rights are distributable to stockholders of record as of the close of business on November 23, the company noted. "Generally, the Rights Agreement works by causing substantial dilution to any person or group that acquires beneficial ownership of ten percent or more of the Common Shares without the approval of the Board. As a result, the overall effect of the Rights Agreement and the issuance of the Rights may be to render more difficult or discourage a merger, tender or exchange offer or other business combination involving the Company that is not approved by the Board. The Rights Agreement is not intended to interfere with any merger, tender or exchange offer or other business combination approved by the Board. The Rights Agreement also does not prevent the Board from considering any offer that it considers to be in the best interest of its stockholders," the filing stated.
BYND MCD

Hot Stocks

10:50 EST Beyond Meat falls after McDonald's unveils plans for plant burger - Shares of Beyond Meat (BYND) are down after McDonald's (MCD) announced plans to develop its own line of plant-based burgers. Shares of Beyond Meat are down 5% to $184.40 in morning trading.
ZM

Hot Stocks

10:38 EST FTC says Zoom to implement 'robust information security program' under agreement - Zoom Video Communications will be required to implement a robust information security program to settle FTC allegations that the video conferencing provider engaged in a series of deceptive and unfair practices that undermined the security of its users, the FTC stated in a post on its website regarding an agreement containing a consent order. Reference Link
MCD

Hot Stocks

10:37 EST McDonald's may do line of plant-based options
MCD

Hot Stocks

10:37 EST McDonald's has developed McPlant, its own plant-based burger - Comments taken from the company's investor update.
JPM

Hot Stocks

10:18 EST JPMorgan CFO: Credit card customer retention 'looking really good'
JPM

Hot Stocks

10:18 EST JPMorgan sees credit card losses peaking in 2H21 - Comments taken from BofA Securities Future of Financials Virtual Conference 2020.
AMD...

Hot Stocks

10:16 EST Tesla considering AMD chips, Reddit user claims, citing 'reliable' leaker - A poster to the r/teslamotors blog on Reddit, "KeyboardGunner," said "a reliable AMD leaker," Patrick Schur, has claimed that Tesla (TSLA) "wants to use" AMD's (AMD) Navi 23 for their cars' infotainment systems. According to "KeyboardGunner" posting on the Reddit topic over the weekend: "With Elon Musk not so subtly hinting at wanting to bring The Witcher games and Minecraft to the cars and the overall push towards gaming on the infotainment, it makes sense that they would want to replace the weak Intel Atoms currently powering the infotainment system (MCU2). Navi 23 would be based on AMDs next generation of graphics technology (RDNA 2). Likely a full SoC." Reference Link
BX

Hot Stocks

10:15 EST Blackstone to acquire Therma Holdings, terms not disclosed - Blackstone announced that private equity funds managed by Blackstone Energy Partners have entered into a definitive agreement to acquire Therma Holdings, a portfolio company of Gemspring Capital. The acquisition of Therma continues Blackstone's support for the transition to cleaner, affordable energy. Therma is a leading specialty mechanical, electrical and controls services company focused on designing, building, and servicing complex systems in mission-critical facilities. Therma's 2,200 professionals and engineers deliver services that are core to improving and maintaining energy efficiency for leading companies across the technology, life sciences, healthcare and data center sectors. Private equity funds managed by Blackstone Energy Partners are also acquiring RE Tech Advisors, an energy and sustainability consulting firm. RE Tech will be integrated into Therma and the combined company will offer customers a comprehensive suite of sustainability, carbon reduction, and energy management services. RE Tech designs, administers, and tracks award-winning energy efficiency and environmental, social and governance programs for clients - which include leading real estate investors, owners, and governments. In total, their 45+ professionals have delivered more than $200 million of utility cost reductions by implementing approximately 10,000 energy efficiency measures across 3,000+ assets. RE Tech has been working with Blackstone on portfolio company projects since 2014. Completion of the transaction, which is expected to occur in the fourth quarter of 2020, is subject to regulatory approvals and customary closing conditions.
CUK

Hot Stocks

10:06 EST Carnival plc rises 41.3% - Carnival plc is up 41.3%, or $4.92 to $16.84.
PEB

Hot Stocks

10:06 EST Pebblebrook Hotel rises 47.9% - Pebblebrook Hotel is up 47.9%, or $5.96 to $18.40.
AMC

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10:00 EST AMC Entertainment rises 52.6% - AMC Entertainment is up 52.6%, or $1.31 to $3.80.
CSSE

Hot Stocks

09:59 EST Chicken Soup for the Soul's Crackle Plus contracts with Amagi - Chicken Soup for the Soul Entertainment announced the collaboration between Crackle Plus and Amagi to power the linear channel experience for Crackle, Popcornflix and other channels on a growing list of FAST platforms. At launch, Crackle and Popcornflix linear channels will be available on platforms like Plex and VIZIO Watch Free, with additional platforms and channels expected to be announced soon.
MKGI

Hot Stocks

09:58 EST Monaker Group completes direct integration with HomeToGo - Monaker Group and HomeToGo have completed a direct integration to search and book Monaker available Alternative Lodging Rental properties. Individual travelers using HomeToGo's powerful search engines now have seamless access through the MBE connection to all of Monaker's instantly bookable ALR properties located in prime locations around the world.
IEA

Hot Stocks

09:57 EST Infrastructure and Energy Alternatives appoints Michael Della Rocca to board - Infrastructure and Energy Alternatives announced the appointment of Mr. Michael Della Rocca to the Company's Board of Directors, effective immediately. Mr. Della Rocca has been designated a Class I director and meets the Nasdaq independence standards. He will serve as an independent director on the Bid Review Committee and Compensation Committee. Mr. Della Rocca's appointment increases the size of IEA's Board of Directors to eight members. Most recently, Mr. Della Rocca was as a partner at McKinsey & Company, retiring in 2020 after a six-year tenure with the firm.
HEXO

Hot Stocks

09:56 EST Hexo appoints Trent MacDonald as CFO - HEXO announced that Trent MacDonald's security clearance request under the Cannabis Act has been granted by Health Canada. As previously announced, Mr. MacDonald had been appointed to the Company's executive leadership team in the acting role of CFO, with his permanent role as CFO to commence upon the successful completion of Health Canada's security clearance process for key personnel. With his security clearance having been granted, Mr. MacDonald now moves into a permanent role as CFO.
DSX

Hot Stocks

09:55 EST Diana Shipping announces direct continuation of contract for m/v Medusa - Diana Shipping announced that, through a separate wholly-owned subsidiary, it has entered into a time charter contract with Cargill International S.A., Geneva, for one of its Kamsarmax dry bulk vessels, the m/v Medusa. The gross charter rate is US$11,000 per day, minus a 4.75% commission paid to third parties, for a period until minimum 10 January 2022 up to maximum 20 March 2022. The new charter period is expected to commence by mid-November 2020. The "Medusa" is a 82,194 dwt Kamsarmax dry bulk vessel built in 2010. This employment is anticipated to generate approximately $4.52 million of gross revenue for the minimum scheduled period of the time charter.
PSHG

Hot Stocks

09:53 EST Performance Shipping announces acceptance of signed offer letter from Piraeus - Performance Shipping announced that it has accepted an offer letter whereby it intends to enter into an agreement for a new amortizing term loan facility of up to $31.5 million with Piraeus Bank through three separate wholly-owned subsidiaries of the Company. This Facility is subject to the completion of customary closing conditions and the execution of a final loan agreement by the Company and its lenders. Proceeds from the Facility will be used to refinance an existing term loan facility for the M/T P. Fos and M/T P. Kikuma with Nordea Bank Abp, filial i Norge, through a first advance of up to $22.5 million and to partially finance the acquisition of a fifth Aframax tanker vessel through a second advance of up to $9.0 million. This Facility shall bear interest at the rate of LIBOR plus a margin of 2.85% per annum. Assuming that the Company draws down the entire amount available under both advances, the Facility will be repayable in sixteen quarterly installments of US$1.1 million, and concurrent with the sixteenth quarterly installment, within four years from the drawdown date, the Company will owe a balloon payment of $13.9 million. Separately, the Company has obtained approval from Nordea Bank Abp, filial i Norge to amend the existing credit facility, reducing the quarterly installments on the remaining $28.1 million term loan secured by the M/T Blue Moon and M/T Briolette.
TZA

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09:53 EST Small Cap Bear 3x falls -21.2% - Small Cap Bear 3x is down -21.2%, or -$2.65 to $9.87.
FAZ

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09:53 EST Direxion Financial Bear 3x falls -24.3% - Direxion Financial Bear 3x is down -24.3%, or -$3.10 to $9.65.
NLS

Hot Stocks

09:52 EST Nautilus falls -31.3% - Nautilus is down -31.3%, or -$8.70 to $19.10.
CNK

Hot Stocks

09:52 EST Cinemark rises 41.8% - Cinemark is up 41.8%, or $3.77 to $12.78.
ACB

Hot Stocks

09:52 EST Aurora Cannabis rises 41.7% - Aurora Cannabis is up 41.7%, or $4.08 to $13.87.
GLBS

Hot Stocks

09:49 EST Globus Maritime announces charter to M/V Galaxy Globe - Globus Maritime announced that it has secured new time charter employment for its recently acquired m/v Galaxy Globe. The vessel has been chartered to a Europe-based charterer. The charter commenced on November 8, 2020 and has a minimum 10 months or a maximum of 14 months, at the charterer's option, which is expected to generate gross revenue of approximately $3,200,00 assuming the charter continues for the minimum scheduled period and approximately $4,900,000 if the charter continues for the maximum period, in each case assuming no offhire days.
EDIT BAYRY

Hot Stocks

09:47 EST Editas Medicine appoints Lisa Michaels as CMO - Editas Medicine (EDIT) announced that it named Lisa Michaels, M.D., as the Company's EVP and CMO, effective immediately. Dr. Michaels will lead clinical research and drug development for the Company's pipeline of experimental medicines. Michaels joins Editas Medicine from Bayer Pharmaceuticals (BAYRY) where she spent more than 10 years in drug development, leading teams from early research and drug discovery through regulatory approval, commercial launch, and life cycle management. Most recently, she served as head of Bayer's Rare Diseases, Cell & Gene Therapy therapeutic area.
AMC

Hot Stocks

09:47 EST AMC Entertainment rises 67.1% - AMC Entertainment is up 67.1%, or $1.67 to $4.16.
CRSR

Hot Stocks

09:46 EST Elgato partners with Pipeline - Elgato announced a multi-year partnership with Pipeline, the leading training and mentorship platform for aspiring live streamers. Both CORSAIR and Elgato have a long history of building and refining the tools needed to be a successful creator, and adding Pipeline's unique education and community platform creates a set of services that will help any streamer kick-start their career. Under the terms of the partnership, Elgato and Pipeline are offering a Streamer Starter Kit that includes a twelve-month Pipeline membership and three Elgato products: the Wave:1 microphone, Stream Deck Mini broadcast controller, and the newly launched Ring Light. The partnership will also see the launch of the Pipeline x CORSAIR Streamer Scholarship Program, a first-of-its-kind support system which will help amateur content creators go full-time, with financial support as well as new studio gear from CORSAIR and Elgato.
CMPI

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09:45 EST Checkmate Pharmaceuticals presents updated data with CMP-001 - Checkmate Pharmaceuticals announced the presentation of new data from two ongoing clinical trials evaluating CMP-001, Checkmate's Toll-like receptor 9 agonist, in combination with the anti-PD-1 antibodies pembrolizumab or nivolumab, in patients with melanoma. Intratumoral injection of CMP-001, a Toll-like receptor 9 agonist, in combination with pembrolizumab reversed programmed death receptor 1 blockade resistance in advanced melanoma: In the SITC 2020 Virtual Press Conference, November 9, between 7:45am-9:00am ET, and in the Virtual Poster Hall, November 11-14, 2020 between 9:00am-5:00pm ET, Dr. Mohammed Milhem, Chief, Section of Oncology, and Clinical Professor of Internal Medicine, University of Iowa Healthcare, presents updated data from an ongoing Checkmate-sponsored clinical trial of CMP-001 in combination with pembrolizumab or as a monotherapy. Key highlights from these clinical data as of the data cut-off of September 30, 2020 include: CMP-001 in combination with pembrolizumab: In patients treated with CMP-001 PS20 0.01% in combination with pembrolizumab, the best ORR by RECIST v1.1 was 23.5%, including 7 complete responses and 16 partial responses, and 27.6% including patients with responses after initial progressive disease. The Kaplan Meier estimate for median duration of response across all patients was 19.9 months for both RECIST v1.1 responders and RECIST v1.1 responders plus post-progressive disease responders. The mean regression in injected and non-injected target lesions was similar in responding patients. Most treatment related adverse events were Grade 1 or 2 and included flu-like symptoms, including chills, fever, fatigue, nausea, vomiting, and headache, and injection site pain. The most common treatment-related Grade 3 or 4 adverse events were hypotension and hypertension. No Grade 5 treatment-related adverse events were reported. CMP-001 monotherapy . Of the 40 patients treated with CMP-001 monotherapy, 7 patients achieved a partial response by RECIST v1.1, and the median duration of response was 5.6 months. Most treatment-related adverse events were Grade 1 or 2 and included flu-like symptoms including chills, fever, nausea, fatigue, and headache. The only treatment-related Grade 3 adverse event in more than 1 patient was hypotension. No Grade 4 or 5 treatment-related adverse events were reported. Phase II Trial of Neoadjuvant Nivolumab and Intra-Tumoral CMP-001 in High-Risk Resectable Melanoma: In a Virtual Oral Presentation on Wednesday, November 11, 2020 at 5:30pm ET, Dr. Diwakar Davar, Assistant Professor of Medicine at the University of Pittsburgh School of Medicine, presents data from an investigator-sponsored trial evaluating neoadjuvant treatment with CMP-001 in combination with nivolumab in patients with Stage IIIB/C/D Melanoma. Key highlights from these clinical data included: 30 patients were evaluable for efficacy per protocol. Pathological responses were observed in 70% of patients, and the primary outcome measure of major pathological response rate was 60%. The response breakdown was as follows: Pathological Complete Response Pathological Major Response, Pathological Partial Response. The median RFS has not been reached. 1-year RFS was 89% in patients with major pathological response and 90% in patients with any pathological response. 31 patients were evaluable for safety per protocol. CMP-001 in combination with nivolumab was generally well-tolerated with an acute toxicity profile consisting predominantly of Grade 1/2 TRAEs. The only treatment-related Grade 3 adverse event in more than 1 patient was hypertension. No Grade 4/5 TRAEs were reported. There were no dose limiting toxicities or delays in surgery related to neoadjuvant treatment. Response was associated with evidence of intratumoral and peripheral immune activation. Intravenous CMP-001, a CpG-A Toll-like receptor 9 agonist delivered via a virus-like particle, causes tumor regression in syngeneic Hepa1-6 mouse models of hepatocellular carcinoma: In the Virtual Poster Hall, November 11-14, 2020 between 9:00am-5:00pm ET, Dr. Arthur M. Krieg, Founder and Chief Scientific Officer of Checkmate Pharmaceuticals, presents data from a preclinical study of CMP-001 plus PD-1 blocking antibody in mouse models of hepatocellular carcinoma. In orthotopic mouse models of HCC, the antitumor activity of intravenous CMP-001 was greater than PD-1 blockade and comparable to sorafenib. CMP-001 intravenous was more active than CMP-001 subcutaneous in this model, consistent with increased liver exposure with intravenous infusion. CMP-001 intravenous may be a promising treatment option to explore in future clinical research for patients with primary or metastatic liver cancers.
ABVC

Hot Stocks

09:37 EST American BriVision issues clinical study report for ABV-1505 Phase II trial - American BriVision issued a full clinical study report of its ABV-1505 Phase II Part I clinical trial conducted at the University of California, San Francisco for the treatment of adult Attention-Deficit Hyperactivity Disorder. Additionally, PDC-1421, the active pharmaceutical ingredient of ABV-1505, had been used recently in a Phase II clinical study conducted at Stanford University to successfully treat Major Depression Disorder. The Phase II Part I clinical study for treating ADHD found that the PDC-1421 Capsule was safe, well-tolerated and efficacious during its treatment and follow-up period with six adult patients. For the primary endpoints, the percentages of improvement in Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated-IV score from baseline through eight weeks of treatment were 83.3% in the Intention-To-Treat population and 80.0% in the Per-Protocol population. Both low and high doses of PDC-1421 Capsule met the primary end points by passing the required 40% population in ADHD-RS-IV test scores. Overall, the results from this study, which demonstrate the therapeutic value of PDC-1421, support further clinical development of ABV-1505 for the treatment of adult ADHD.
CRSR

Hot Stocks

09:35 EST Corsair Gaming acquires Gamer Sensei, terms not disclosed - Corsair Gaming announces it has acquired Gamer Sensei, the world's biggest esports coaching platform. Founded in 2016, Gamer Sensei connects gamers of all skill levels, from rookies to aspiring professionals, with experienced coaches who are more than just top gamers - they're great teachers. Ranging from professional gamers, both past and present, to gamers who have climbed the ranks to the very top of their games, Gamer Sensei coaches combine the skills to succeed at the highest level of games, with a patient, tailored and flexible approach to help you improve your in-game performance. Whether you're learning the ropes, climbing the ranks, or polishing your skills to the highest level, Gamer Sensei coaches provide personalized assessments and 1-on-1 coaching for more than 20 of today's most popular games, from League of Legends and DOTA 2 to Fortnite and Call of Duty: Warzone. Gamer Sensei is the largest esports coaching platform with more than 100,000 gamers coached so far, offering the widest choice in coaches and games for players looking to take their game to the next level. For aspiring coaches, Gamer Sensei offers a safe and stable platform to turn your passion into a profession, putting you in control of your available hours and coaching format.
SURF

Hot Stocks

09:34 EST Surface Oncology to present SRF388, SRF114 preclinical data - Surface Oncology announced that preclinical data on SRF388, a first in class IL-27 blocking antibody in clinical trials for patients with cancer, and SRF114, a CCR8-selective antibody, will be presented at the Society for Immunotherapy for Cancer's 35th Anniversary Annual Meeting, which will be held virtually on November 11-14, 2020. Details of Surface's SITC presentations: Presentation Title: Increased Serum Levels of EBI3 Are Associated with Poor Outcome in Hepatocellular Carcinoma Patients and SRF388, a First-in-Class IL-27 Blocking Antibody, Inhibits the Growth of Murine Liver Tumors" Summary: SRF388 is a monoclonal antibody designed to inhibit the immuno-suppressive cytokine IL-27.. Circulating levels of the EBI3 subunit of IL-27 are elevated in a subset of patients with HCC and inversely correlated with overall survival. SRF388 enhances proinflammatory cytokine production in combination with PD-1 blockade in vitro in activated peripheral blood mononuclear cells from healthy donors and patients with HCC. Furthermore, SRF388 demonstrates single-agent activity in vivo in a murine orthotopic model of HCC. Presentation Title: SRF114 is a Fully Human, CCR8-Selective IgG1 Antibody that Induces Destruction of Tumor Tregs Through ADCC: Summary: Targeting CCR8 with SRF114 causes depletion of intra-tumoral Tregs, important regulators of peripheral immune tolerance, through ADCC. SRF114 is highly selective for CCR8; no off-target binding was identified following extensive screening.
CAPR

Hot Stocks

09:33 EST Capricor Announces 'positive' preclinical data for COVID-19 vaccine candidate - Earlier, Capricor Therapeutics, in collaboration with researchers at Johns Hopkins University, announced that "positive" data from a preclinical study for a multivalent exosome-based mRNA vaccine for COVID-19 has been posted on the bioRxiv preprint server and will be submitted for publication. Dr. Linda Marban, Ph.D., CEO of Capricor, said, "Capricor's unique exosome-based mRNA delivery platform is a novel type of SARS-CoV-2 potential vaccine being developed to aid in the worldwide fight against this virus, which continues to plague the world. Exosomes are the body's own drug delivery vehicle, produced by all cells, abundant in all biofluids, and demonstrated to be safe by decades of transfusion and transplantation medicine. This study represents a major step forward for our joint effort to develop exosome-based therapeutics. Furthermore, it highlights the ability of our exosome-based RNA delivery platform to deliver multiple mRNAs, induce long-lasting immune responses to multiple SARS-CoV-2 proteins, and potentially elicit a broad-based, cellular immunity that extends beyond the Spike protein alone, which is the sole target of leading vaccine candidates."
LPTX

Hot Stocks

09:32 EST Leap Therapeutics presents DKN-01 data at AACR conference - Leap Therapeutics announced the presentation of clinical data from its Phase 2 clinical trial of DKN-01 in patients with recurrent epithelial endometrial cancers at the AACR Virtual Special Conference on Endometrial Cancer: New Biology Driving Research and Treatment being held November 9-10, 2020. DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 protein. DKN-01 demonstrated single agent activity in the EEC patients treated in the study, particularly in biomarker-selected subgroups relating to DKK1 biology. Patients with a Wnt signaling alteration had a higher overall response rate, greater objective disease control rate, and longer median overall survival compared to patients without a Wnt signaling alteration. Patients with Wnt activating mutations, a subgroup of the Wnt signaling alterations, had the longest progression-free survival and OS of the subgroups evaluated. Wnt activating mutations are associated with higher tumoral DKK1 expression, and DKK1-high patients treated with DKN-01 monotherapy experienced a higher ORR and ODCR and longer PFS compared to DKK1-low patients. "Pathways modulated by DKK1, such as the Wnt/Beta-catenin and PI3kinase/AKT pathways, are frequently mutated in patients with endometrial cancer, and high levels of DKK1 can both promote tumor growth and create an immunosuppressive tumor microenvironment. The DKN-01 results in endometrial cancer patients with Wnt activating mutations and high tumoral DKK1 expression continue to suggest that treatment with DKN-01 could provide clinically meaningful benefit to patients with advanced disease and few treatment options," said Rebecca Arend, M.D., Associate Professor, Gynecologic Oncology Division, University of Alabama at Birmingham, and Associate Scientist, O'Neal Comprehensive Cancer Center.
SRNE

Hot Stocks

09:31 EST Sorrento announces FDA IND filing for antibody against SARS-CoV-2 - Sorrento Therapeutics announced that it is filing an investigational new drug application, or IND, for intravenous COVI-AMG to treat COVID-19 patients with mild symptoms and to evaluate safety and pharmacokinetics in healthy volunteers. Sorrento has previously submitted an IND for COVI-GUARD, or STI-1499, the parent antibody for COVI-AMG. That submission was cleared by the FDA in September. "Sorrento has built on the knowledge from the prior IND requirements to file this new IND, including information and data about Sorrento's affinity maturation process that further enhanced the potency of this antibody," the company said. As Sorrento previously announced, in preclinical studies, STI-2020 demonstrated a 100% neutralizing effect and at a very low dose prevented SARS-CoV-2 from infecting healthy cells and causing COVID-19-like disease in golden Syrian hamsters.
EEVVF

Hot Stocks

09:30 EST NextLeaf Solutions signs cannabis extraction agreement with Eve & Co. - Nextleaf Solutions announced that its wholly-owned subsidiary Nextleaf Labs has entered into a Cannabis Extraction Agreement with Natural MedCo, a wholly-owned subsidiary of Eve & Co Incorporated. NMC is based in Strathroy, Ontario and operates over one million square feet of licensed production and distribution through provincial adult-use channels and international markets. Pursuant to the Agreement, NMC will provide cannabis biomass to be processed into distilled THC and CBD oils at Nextleaf's closed-loop extraction plant in Metro Vancouver. The resulting bulk THC and CBD oils will be sold by Nextleaf Labs through its Commercial Partners Program and the wholesale market, with the net proceeds of such sales to be shared by Nextleaf Labs and NMC. The initial term of the Agreement will end on the earlier of (a) 12 months, and (b) the date upon which 5,000 kilograms of cannabis biomass has been processed, and automatically renews thereafter for successive one-year terms. Nextleaf Solutions' investment in IP and its existing fixed asset base provides a robust platform to scale, and a clear competitive advantage to supply low-cost cannabinoid distillate produced at the Company's ultra-efficient cannabis oil refinery in British Columbia.
SRNE

Hot Stocks

09:30 EST Sorrento announces FDA IND filing for antibody against SARS-CoV-2
PEIX

Hot Stocks

09:29 EST Pacific Ethanol agrees to sell Idaho grain handline facilities - Pacific Ethanol announced that it has entered into an agreement with Liberty Basin, LLC to sell 134 acres, rail loop and grain handling assets at its Pacific Ethanol Magic Valley plant in Burley, Idaho for $10M in cash. Pacific Ethanol will retain the ethanol production facility and terminal on the remaining 25 acres and will enter into certain agreements with Liberty Basin, LLC for delivery of grain to the plant. The sale is expected to close on or before November 30, 2020, subject to customary closing conditions. "The sale of real estate and grain handling assets at our Magic Valley facility to Liberty Basin, LLC further demonstrates our commitment to strengthening our balance sheet through monetizing idled assets at a value accretive to shareholders and repurposing the production assets," said Mike Kandris, Pacific Ethanol's CEO. "Liberty Basin provides a great strategic alliance for managing grain delivery to the renewable fuel plant and to meet animal feed demand in the Idaho markets. Pacific Ethanol will continue to own the ethanol plant with the intent to upgrade product value prior to restarting production. "As we have said in our recently announced strategic realignment toward a business focus in specialty alcohols and essential ingredients, Pacific Ethanol will repurpose or sell its idled plants. This sale is a first step toward the objective to add value to our Magic Valley plant. We will continue with our strategic realignment plan and anticipate communicating additional transactions in the future."
CVU

Hot Stocks

09:28 EST CPI Aerostructures appoints Richard Caswell to board of directors - CPI Aerostructures announced that Richard Caswell has been appointed to its Board of Directors, effective November 4, 2020. He was also appointed Chairperson of the Audit and Finance Committee. Caswell is a finance and accounting executive who possesses extensive experience in financial management, including government contracting, financial planning and analysis, accounting, mergers & acquisitions and taxation. He retired after 22 years at United Technologies Corporation where he served, in his latest role, as Vice President of Finance and Chief Financial Officer for the Power, Controls and Sensing System segment of United Technologies Aerospace Services.
WSTG

Hot Stocks

09:25 EST Wayside Technology acquires CDF Group for $17.4M - Wayside Technology Group announced it has acquired CDF Group, a UK-based cloud, software and IT distributor and services provider. CDF primarily goes to market under two brands: Grey Matter, which is a value-added reseller providing cloud, software and technical services; and Sigma Software Distribution, which provides innovative software products to VARs throughout EMEA. "Sigma works closely with its vendors and VARs, distributing a high-caliber portfolio of software solutions across a variety of industries. Both Sigma and Grey Matter have deep expertise in Microsoft Azure, are Microsoft Gold Partners with 9 competencies and hold various direct agreements with Microsoft," the company said. Under the terms of the agreement, Wayside is acquiring CDF for approximately $17.4M, or GBP 13.3M, subject to working capital and other adjustments. For its fiscal year ended June 30, 2020, CDF reported approximately $8.9M, or GBP 6.9M, in gross profit and $2.0M, or GBP 1.6M, in EBITDA. The acquisition is expected to be accretive to EBITDA margin and net income and increase Wayside's annual gross billings by approximately 10%, prior to any revenue synergies, the company said.
ENTX

Hot Stocks

09:25 EST Entera Bio sees cash sufficient into 2Q21 - Entera expects to report efficacy results for the EB613 Phase 2 clinical trial including the full 3-month biomarker data in the first quarter of 2021, and the efficacy and safety results for the full trial in the second quarter of 2021. As of September 30, 2020, the Company had cash and cash equivalents of $7.1 million and believes its current cash position will be sufficient to fund its operations into the second quarter of 2021.
ENTX

Hot Stocks

09:24 EST Entera Bio completes enrollment in Phase 2 trial of Eb613 - Entera Bio announced the completion of enrollment in the ongoing Phase 2 clinical trial of EB613. EB613 is an orally delivered human parathyroid hormone (1-34), or PTH, positioned as the first potential oral bone building product to treat osteoporosis patients. The Phase 2 clinical trial of EB613 is a dose-ranging, placebo-controlled study in postmenopausal female subjects with osteoporosis, or low bone mineral density (BMD), and is being conducted at four leading medical centers in Israel. The trial was initially designed with three treatment groups including doses of 0.5mg, 1.0mg and 1.5mg. In July 2020, the Company amended the Phase 2 protocol based on a review of the 3-month interim biochemical marker and safety data from the first 80 subjects randomized. The two lower doses (0.5 mg and 1.0 mg) of EB613 were discontinued and a 2.5 mg dose of EB613 was added. The initial target enrollment was 160 subjects, with final enrollment of 161 subjects. In August 2020, the Company announced 6-month interim biomarker and BMD data from the first 50%, or 80 patients, enrolled in this trial. The data indicated EB613 has a meaningful and positive impact on lumbar spine BMD in a dose dependent manner. EB613 generated a mean placebo adjusted increase in lumbar spine BMD of 2.15% (p = 0.08) for the 14 patients in the 1.5 mg treatment arm, as compared to the 16 patients in the placebo arm. The placebo-adjusted increase was comprised of a mean BMD increase of 1.44% in the 1.5 mg treatment arm compared to a mean decrease of 0.71% in the placebo arm. An additional analysis of BMD changes in all EB613 treatment groups showed a significant dose-dependent trend in the percentage change in lumbar spine BMD.
CCI

Hot Stocks

09:23 EST Crown Castle names Chris Levendos as COO - Fiber, effective December 1 - Crown Castle International announced that, effective December 1, 2020, Chris Levendos has been appointed to lead Crown Castle's small cells and fiber solutions activities as Executive Vice President and COO - Fiber. Levendos joined Crown Castle in 2018 and is currently Vice President of Network Engineering and Operations, responsible for the oversight of the company's national fiber and small cell infrastructure network. As previously announced, James D. Young, Crown Castle's current Executive Vice President and COO - Fiber, is retiring from Crown Castle and will remain with the company through February 2021 in order to assist with various matters, including the transition of Levendos as his successor.
BIMI

Hot Stocks

09:23 EST BOQI International Medical enters MOU to acquire Chongqing Cogmer - BOQI International Medical announces the signing of a Memorandum of Understanding with Chongqing Cogmer Biology Technology Co. on October 28, 2020. Pursuant to the MOU, BOQI International Medical Inc. and Chongqing Cogmer Biology Technology Co., Ltd agreed to move forward on four stages of work, including completing all relevant assessment and audit of Cogmer Biology, completing on-site audit and evaluation of Cogmer Biology, signing a Stock Purchase Agreement based on the audit and evaluation result, and completing the relevant business procedures for the transaction. Chongqing Cogmer Biology Technology Co. Ltd is a modern technology company that provides comprehensive solutions for medical laboratories in hospitals and clinics. Cogmer Biology is mainly engaged in the sales of medical equipment and in vitro diagnostic reagents, including immunofluorescence analyzer, chemiluminescence immunoassay analyzer, automatic hematology analyzer, and fully automatic biochemistry analyzer. At present, Cogmer Biology has 100+ cooperative manufacturers, 200+ distribution partners, and 500+ direct customers.
MNPR

Hot Stocks

09:23 EST Monopar announces issuance of new patents for Validive - Monopar Therapeutics announced a series of recently issued patents for its Phase 2b/3 clinical-stage lead product candidate, Validive. These patents, including U.S. Patent No. 10,675,271, provide claims covering "Clonidine and/or clonidine derivatives for use in the prevention and/or treatment of adverse side effects of chemotherapy". "These recently issued patents broaden the patent protection for the use of Validive in cancer patients," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar. "Specifically, they provide protection into 2035 for the potential ability of Validive to prevent or treat common chemotherapy-associated side effects such as gastrointestinal disorders, respiratory disorders, fatigue and headache."
TRNO

Hot Stocks

09:23 EST Terreno Realty acquires Washington industrial property for $11.7M - Terreno Realty acquired an industrial property located in Bellevue, Washington for a purchase price of approximately $11.7M. The property consists of one industrial flex building containing approximately 39,000 square feet on 2.1 acres. The property is at 13150 SE 32nd Street, adjacent to the intersection of I-90 and I-405, provides one dock-high loading position and parking for 80 cars. The property is 100% leased to one tenant. The estimated stabilized cap rate of the property is 4.9%.
IGXT

Hot Stocks

09:22 EST IntelGenx announces publication of study evaluating Montelukast - IntelGenx announced that the peer-reviewed journal, International Journal of Clinical Pharmacy, has published a study on Montelukast's effect on neurological aging. IntelGenx is currently conducting a Phase 2a clinical study of Montelukast VersaFilm for the treatment of Alzheimer's disease, the company noted. "This study builds on a similar study conducted in 2017 that suggested that Montelukast could alleviate the cognitive decline associated with human aging," said Dr. Ludwig Aigner, a member of IntelGenx's Scientific Advisory Board. "We are very encouraged that the current study, which includes additional prescription database data and results from the Tromso Study, further supports Montelukast's potential to postpone mental aging."
GRA

Hot Stocks

09:21 EST W.R. Grace licenses UNIPOL PP Process Technology - W. R. Grace & Co. has licensed its UNIPOL PP Process Technology to PT Pertamina Rosneft Pengolahan dan Petrokimia, a joint venture between Indonesia's PT Pertamina and Russia's Rosneft Oil Company. The UNIPOL PP facility, located in Tuban, Indonesia, will include two lines, each designed to produce 580KTA for a total of 1160KTA of polypropylene. The agreement includes a long-term catalyst supply contract and a license for Grace's UNIPOL PP UNIPPAC Process Control Software. This tailored package, in conjunction with the UNIPOL PP process technology, guarantees the opportunity for PRPP and Grace to work closely together over the lifetime of the plant, resulting in a fully optimized solution.
NVAX

Hot Stocks

09:21 EST Novavax COVID-19 vaccine granted Fast Track designation by FDA - Novavax announced that the U.S. Food and Drug Administration has granted Fast Track Designation for NVX-CoV2373, the Company's COVID-19 vaccine candidate. Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax' nanoparticle technology and includes its proprietary MatrixM adjuvant. Novavax expects to begin its pivotal Phase 3 clinical trial in the United States and Mexico by the end of November. Data from the event-driven trial could support global authorization and approval, including in the U.S. The Company's ongoing Phase 3 clinical trial in the UK to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 is expected to be fully enrolled by the end of November. Depending on the overall COVID-19 attack rate, interim data in the UK trial, which is also event-driven, are expected as soon as early first quarter 2021.
EVC

Hot Stocks

09:20 EST Entravision appoints Juan Saldivar as Chief Digital, Strategy Officer - Entravision Communications announced the appointment of Juan Saldivar as its new Chief Digital, Strategy and Accountability Officer. In his new role, Mr. Saldivar will be responsible for overseeing Entravision's digital business units, corporate strategy and business development and overall business unit reporting and accountability.
LEAF

Hot Stocks

09:20 EST Leaf Group says group's efforts to force sale 'at odds with best interests' - Leaf Group issued a letter to its shareholders in response to a recent public letter from a group of Leaf Group shareholders, which stated in part: "It is clear that the proposal's provisions have one purpose: to force the near-term sale of the Company. The Investor Group has been pursuing a sale since it began its campaign in June 2020, and as we have said before, we believe that the Investor Group's continued efforts to force a sale are driven by a narrow and self-serving agenda that is directly at odds with the best interests of our broader investor base. We believe that it is in all shareholders' best interest for the Company to continue to drive results to increase shareholder value."
AFMD

Hot Stocks

09:18 EST Affimed N.V. reports preclinical data to be presented at STIC meeting - Affimed N.V. announced that preclinical data - generated through a collaboration with The University of Texas MD Anderson Cancer Center and Washington University School of Medicine - will be the focus of an oral presentation at the virtual Annual Meeting of the Society for Immunotherapy of Cancer, or SITC, identifying "promising combinations" of Innate Cell Engager AFM13 with cytokine-activated adult blood or cord blood natural killer cells against CD30-positive hematological malignancies. Nancy D. Marin, PhD, of Washington University School of Medicine will present these data virtually on Wednesday, November 11, 2020 from 3:45 - 5:15 p.m. EST. Arndt Schottelius, M.D. PhD, Affimed's Chief Scientific Officer, said, "The current set of preclinical in vitro and in vivo data demonstrate the increased efficacy of AFM13-preloaded cord blood-derived NK cells towards CD30-positive tumor cells. We are excited about these data that laid the groundwork for the ongoing Phase 1 evaluation of this combination to treat patients suffering from CD30+ malignancies."
PFSW

Hot Stocks

09:18 EST Zumnorde chooses LiveArea for BigCommerce site - LiveArea has announced its partnership with German footwear retailer Zumnorde to build and launch a new digital store on BigCommerce and, through site redesign, deliver more consumer-focused online user experiences.
CCC

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09:16 EST Clarivate Analytics divests Techstreet to ASME - Clarivate and The American Society of Mechanical Engineers, or ASME announced that the International Society of Interdisciplinary Engineers, a new for-profit subsidiary of ASME, has acquired Techstreet. Both ASME and Techstreet are positioned at the forefront of the $1.5B standards ecosystem, defining best practices for the industry, which is expected to reach a market size of $1.6B by 2023. Now, these two organizations with complementary strengths and areas of focus will comprise one family, with Techstreet joining ISIE, ASME's new for-profit arm. The combined expertise of these two organizations - along with their proprietary technologies and operational knowledge - will create unique value for the global standards community. Techstreet: an ASME Company will operate independently as part of ISIE, the new commercial arm for ASME. Under this new ownership, ISIE and Techstreet will build on Techstreet's leadership position as one of the fastest growing distributors of technical standards, establishing Techstreet as a highly sought after and trusted technology hub for engineers across the globe.
MLM

Hot Stocks

09:16 EST Martin Marietta appoints Anthony Foxx to board of directors - Martin Marietta Materials announced the appointment of Anthony Foxx as an independent member to its Board of Directors, effective November 6, 2020. With Mr. Foxx's appointment, the Martin Marietta Board is comprised of 11 directors, 10 of whom are independent and six of whom have joined since 2016. Mr. Foxx will serve on Martin Marietta's Finance Committee. Foxx is currently chief policy officer and advisor to the president and chief executive officer of Lyft, which he joined in October 2018
STZ

Hot Stocks

09:14 EST Constellation Brands signs agreement with FTC on E. & J. Gallo acquisition - Constellation Brands announced today that it and E. & J. Gallo Winery have signed an Agreement Containing Consent Order with the Bureau of Competition of the U.S. Federal Trade Commission, or FTC, regarding Gallo's pending acquisition of a portion of Constellation's wine and spirits portfolio principally priced at $11 retail and below, including certain related facilities located in California, New York, and Washington State. The proposed consent order marks the final stages in the FTC review process and remains subject to review and approval by the FTC Commissioners, who typically provide their final review within 30 to 45 days. Therefore, Constellation anticipates closing in the fourth quarter of fiscal 2021. "The proposed consent order, if accepted by the FTC Commissioners, would allow Constellation and Gallo to complete the sale under the terms of the Second Amended and Restated Asset Purchase Agreement announced in May 2020. As set forth in the May 2020 agreement the transaction price is approximately $1.03B, subject to closing adjustments, of which $250M is an earnout if brand performance provisions are met over a two-year period after closing. Constellation also expects to close its separate but related transactions with Gallo to divest the New Zealand-based Nobilo Wine brand and related assets for $130M and with Sazerac to divest the Paul Masson Grande Amber Brandy brand, related inventory and interests in certain contracts for approximately $255M by the end of the fourth quarter of fiscal 2021, subject to FTC acceptance of the proposed consent order."
DYNT

Hot Stocks

09:14 EST Dynatronics hires Norman Roegner as CFO - On November 9, the company announced the hiring of Norman Roegner III and his appointment as Chief Financial Officer of the Company, succeeding John A. Krier, who will continue as the Company's Chief Executive Officer. Prior to joining the Company, Mr. Roegner served as Vice President of Finance of Phillips-Medisize, LLC, a subsidiary of Molex. Molex is a subsidiary of Koch Industries and a globally recognized provider of electronic solutions in a wide range of industries, including medical device manufacturing from 2016 to 2019. Prior to his role with Phillips-Medisize, from 1998 to 2016, Mr. Roegner held various leadership roles in the finance, supply chain, sales operations and marketing divisions of the Molex organization. Mr. Roegner holds a B.S. degree in Accountancy from Northern Illinois University and a M.B.A. from DePaul University.
STON

Hot Stocks

09:13 EST StoneMor Partners agrees to sell all assets in Oregon and Washington for $6.2M - StoneMor announced it has signed a definitive agreement to sell the assets of its Oregon and Washington locations to Clearstone Memorial Partners, LLC for a total cash purchase price of $6.2M. The locations included in the transaction are Farnstorm Mortuary in Independence, Oregon, Fir Lawn Memorial Park and Mortuary in Hillsboro, Oregon, Forest Lawn Cemetery in Gresham, Oregon, Hillcrest Memorial Park, Crematory and Mortuary in Medford, Oregon, Keizer Funeral Chapel and Farnstorm Cremation Center in Keizer, Oregon, Memory Gardens Memorial Park and Memory Gardens Mortuary in Medford, Oregon, Peake Funeral Chapel in Milwaukie, Oregon, Restlawn Memory Gardens, Mausoleum and Restlawn Funeral Home in Salem, Oregon, Roseburg Memorial Cemetery in Roseburg, Oregon, Valley View Cemetery in Sutherlin, Oregon, Wilson's Chapel of Roses and Roseburg Cemetery in Roseburg, Oregon, Care Cremation Service in Clackamas, Oregon, Marysville Cemetery in Marysville, Washington and Oakwood Hill Cemetery and Funeral Chapel in Tacoma, Washington. The transactions are targeted to close, subject to confirmatory due diligence and regulatory approvals, on or before December 31, 2020. StoneMor also announced it has completed the previously announced sale of the assets of its remaining California locations to entities owned by John Yeatman and Gary Saxton for a total purchase price of $7.1M, subject to certain additional adjustments. Per the indenture governing its Senior Secured PIK Toggle Notes, StoneMor will use $5.7M of net proceeds from the California sale and 80% of the net proceeds from the sale to Clearstone to redeem a portion of its outstanding Senior Notes.
FRME

Hot Stocks

09:11 EST First Merchants to acquire Hoosier Trust Company; terms not disclosed - First Merchants Corporation announced that it will acquire Indianapolis-based Hoosier Trust Company. Established in 2001, Hoosier Trust Company provides trust and investment management services to clients in Central Indiana. "Hoosier Trust Company has demonstrated tremendous success since its founding, and like First Merchants, the company commits to maintaining the highest standards of integrity and professionalism in client relationships," said First Merchants President & CEO Michael C. Rechin. "This strategic acquisition will further strengthen First Merchants' private wealth practice and continue our efforts to serve as a financial resource for all potential clients in the communities we serve."
BEAM

Hot Stocks

09:09 EST Beam Therapeutics names first CAR-T base editing development candidate - Beam Therapeutics announced that the company will advance BEAM-201, a potent and specific anti-CD7, multiplex edited, allogeneic CAR-T therapy, as a development candidate for the treatment of T-cell acute lymphoblastic leukemia. Preclinical data on BEAM-201 are being presented in a poster session during the Society for Immunotherapy of Cancer's 35th Anniversary Annual Meeting & Pre-Conference Programs, and demonstrate potent, dose-dependent tumor control in vitro and in an in vivo xenograft model. BEAM-201 is a potent and specific anti-CD7, multiplex edited, allogeneic CAR-T development candidate for the treatment of relapsed/refractory T-ALL, a severe disease affecting children and adults with a five-year overall survival of less than 25%. BEAM-201 is produced using a GMP-compliant, clinical-scale process in which T cells derived from healthy donors are simultaneously base edited at four genomic loci then transduced with a lentivirus coding for an anti-CD7 CAR. The resulting cells are universally-compatible, allogeneic CD7-targeting CAR-T cells resistant to both fratricide and immunosuppression. Details of Beam's SITC 2020 presentation of BEAM-201 are as follows: Title: Highly efficient multiplexed base editing enables the development of investigational universal CD7-targeting CAR-T Cells to treat T-AL. In vitro characterization of the effects of base editing in BEAM-201 demonstrated: Simultaneous base editing by a cytosine base editor (CBE) at four target loci in primary human T cells using a clinical-scale process produced 96-99% on-target editing of each of the four genes as measured by next-generation sequencing and flow cytometry; Simultaneous quad base editing of T cells resulted in no detected genomic rearrangements resulting from the editing process; Multiplex base editing did not negatively affect cell expansion during manufacturing; CBE-edited cells decreased expression of the four target genes with minimal effect on other genes, including key members of the p53 pathway that are upregulated in response to DNA double-stranded breaks produced by multiplex editing with nucleases. Further characterization of BEAM-201 in vitro and in a tumor mouse model demonstrated: Beam's GMP-compliant, clinical-scale process resulted in final BEAM-201 CAR-T cell populations with on-target editing efficiencies between 96-99.9% at each of the four target loci, and 85% CAR-expressing cells. As a result, Beam estimates that 91% of cells are bi-allelically quad base edited and 77% of cells have all 5 genetic modifications. The company believes this is the highest level and uniformity of CAR expression and simultaneous editing across four target sites reported at clinical scale to date. BEAM-201 cells demonstrated robust in vitro CD7-dependent cytokine production, and rapid in vitro cytotoxicity. BEAM-201 cells also demonstrated dose-dependent clearance or control, across a 25-fold dose range, of an aggressive disseminated CCRF-CEM T-ALL tumor mouse model.
TXT

Hot Stocks

09:09 EST Xcalibur Aerospace posts on website regarding projected Textron tender offer - The corporate website of Xcalibur Aerospace includes a section regarding a purported "Textron Tender Offer" that directs interested parties to "Send us an email to obtain the Term Sheet for the projected Tender Offer." The site says: "Combining the technologies and exploiting synergies between the two corporations will create a unique platform for increased profitability and economies from a thorough restructuring." The home page of Xcalibur Aerospace also makes reference to a $60.50 per share offer and advises parties to "contact our screening office in London." In pre-market trading, Textron shares are up $5.16, or 13%, to $43.99 amid broad market strength. Reference Link
DEA

Hot Stocks

09:08 EST Easterly Government Properties acquires VA CMOP in South Carolina - Easterly Government Properties announced today that it has acquired a 97,718-square foot Department of Veterans Affairs Consolidated Mail Outpatient Pharmacy in North Charleston, South Carolina. VA - Charleston, a recently delivered single story warehouse, is one of seven regional CMOP's for the VA that are strategically located throughout the country. Services offered at this facility include the filling, packaging and distribution of prescription medicine for veterans residing within this CMOP's regional territory. Notably, VA - Charleston is only one of two CMOPs nationwide that has been authorized to handle the distribution of controlled substances. The VA has demonstrated its long-term commitment to this location through the execution of a brand new, non-cancelable 20-year lease that does not expire until the end of September 2040 and has heavily invested in this facility with a number of service-enhancing capital improvements.
NK

Hot Stocks

09:08 EST NantKwest, ImmunityBio announce study results for COVID-19 vaccine candidate - ImmunityBio announced study results for their human Ad5 COVID-19 vaccine candidate, which shows memory T-cell recall from patients previously infected with SARS-CoV-2 virus. The ability to stimulate SARS-CoV 2 specific T-cells, which recognize the N and S proteins, is a "crucial" part of the novel design of ImmunityBio's vaccine candidate. The antibody- and T cell-based vaccine seeks both to provide protection for the uninfected population and also the potential to clear virally infected cells in infected subjects. It is unclear how long antibodies may provide protection. With the production of both antibodies and T cells, the potential exists for long-term, durable immunity. The results of this study were published in medRxiv. ImmunityBio's vaccine candidate targets both the spike and nucleocapsid proteins of SARS-CoV-2 to activate a multi-pronged attack by the immune system. This is distinct from most vaccine candidates currently in late-stage clinical trials, which target S alone. Recent reports suggest that antibodies to S may be vulnerable to reduced effectiveness because of emerging new mutations, as well as uncertainty over the longevity of the antibody response over time. The hAd5 bivalent COVID-19 vaccine induces T cell immunity and could provide long-term protection against the virus as the antibodies wane over time. An additional distinctive feature of the ImmunityBio vaccine candidate design is its use of a second-generation human adenovirus serotype 5 that has been shown to effectively deliver antigens even in the presence of preexisting adenovirus immunity which is present in up to roughly 60% of the population. Under the terms of a definitive agreement announced on August 24, 2020, ImmunityBio and its affiliate NantKwest agreed to share equally the costs of development, manufacturing, marketing and commercialization of the products each is developing related to COVID-19, including the hAd5 vaccine candidate. Should a product be commercialized successfully, the companies have agreed to a 60-40 percentage split of net profits, with the larger share going to the company that developed the product. The agreement also details the structure of shared governance of the joint collaboration.
ALXO

Hot Stocks

09:07 EST ALX Oncology announces new data from ASPEN-01 - ALX Oncology Holdings announced new results from ASPEN-01, the ALX148 Phase 1b study, evaluating patients with solid tumor malignancies at the Society for Immunotherapy of Cancer's 35th Anniversary Annual Meeting. ALX Oncology reports new preliminary data from the gastric/gastroesophageal junction cancer ("GC") patient cohort receiving ALX148 plus trastuzumab plus chemotherapy, and from the head and neck squamous cell carcinoma ("HNSCC") patient cohort receiving ALX148 plus pembrolizumab plus chemotherapy. In addition, updated data are presented from the GC patient cohort receiving ALX148 plus trastuzumab, and from the HNSCC patient cohort receiving ALX148 plus pembrolizumab. All data reflect response evaluable patients as of October 1, 2020. In patients with greater than2L HER2 positive GC (n=14), whose tumors have progressed upon prior trastuzumab therapy, ALX148 demonstrates a promising initial objective response rate (ORR) of 64% in combination with trastuzumab plus ramucirumab and paclitaxel that compares favorably with historical data. In initial patients with 1L HNSCC who have not received prior treatment for their advanced disease (n=4), ALX148 demonstrates a promising initial ORR of 75%, including a complete response, in combination with pembrolizumab plus 5-fluorouracil and platinum. Updated data from patients with greater than2L HER2 positive GC receiving ALX148 plus trastuzumab suggests promising clinical activity after their tumors have progressed upon prior trastuzumab therapy. Updated data from patients who have never been treated with a PD-1/PD-L1 inhibitor for their greater than2L HNSCC and who received ALX148 plus pembrolizumab suggests clinical activity beyond that expected from pembrolizumab monotherapy. Preliminary data suggests that ALX148 can be safely combined with multi-agent chemotherapy regimens studied with no maximum tolerated dose reached. The maximum administered dose of ALX148 in combination was 15 mg/kg once per week.
MCD

Hot Stocks

09:07 EST McDonald's: New growth strategy will build on inherent strengths - "In countries around the world, we have seen customer behaviors change at an unprecedented pace over the last several months. We believe this presents an opportunity to do something special as we write the next great chapter of McDonald's," said McDonald's President and CEO Chris Kempczinski. "By embracing a bigger, more holistic vision for the future, Accelerating the Arches defines how McDonald's will deliver value to all stakeholders by providing a clear roadmap of what we can do for the millions of customers, in the thousands of communities, we serve each and every day. With our new growth strategy, we will build on our inherent strengths by harnessing our competitive advantages and investing in innovations that enable us to continue to offer fast, easy moments for our customers."
MCD

Hot Stocks

09:06 EST McDonald's sees 2021, 2022 systemwide sales growth in the mid-single digits - As a result of the COVID-19 pandemic and associated resurgences, countries around the world continue to be impacted by economic instability, government regulations and changes in consumer behavior. Due to this ongoing uncertainty, the Company continues to evaluate its financial expectations on an ongoing basis and will provide updates as situations warrant. Based on current conditions, the Company expects its strong foundation and new growth strategy to deliver the following key metrics for 2021 and 2022. Systemwide sales growth in the mid-single digits. For 2021, growth is as compared to 2019. For 2022, unit expansion is expected to contribute 1.5% to 2% to Systemwide sales growth. Operating margin percent in the low-to-mid 40s. Annual G&A spend of about 2.3% of Systemwide sales. Capital expenditures of approximately $2.3 billion, about half of which will be directed towards new unit expansion. Free cash flow conversion greater than 90%. Additionally, the Company's capital allocation priorities remain investing in the business for growth, paying dividends, and returning to pre-COVID-19 debt ratios.
DEA

Hot Stocks

09:06 EST Easterly Government Properties acquires VA CMOP in South Carolina - Easterly Government Properties announced today that it has acquired a 97,718-square foot Department of Veterans Affairs Consolidated Mail Outpatient Pharmacy in North Charleston, South Carolina. VA - Charleston, a recently delivered single story warehouse, is one of seven regional CMOP's for the VA that are strategically located throughout the country. Services offered at this facility include the filling, packaging and distribution of prescription medicine for veterans residing within this CMOP's regional territory. Notably, VA - Charleston is only one of two CMOPs nationwide that has been authorized to handle the distribution of controlled substances. The VA has demonstrated its long-term commitment to this location through the execution of a brand new, non-cancelable 20-year lease that does not expire until the end of September 2040 and has heavily invested in this facility with a number of service-enhancing capital improvements.
NK

Hot Stocks

09:06 EST NantKwest, ImmunityBio announce study results for COVID-19 vaccine candidate - ImmunityBio announced study results for their human Ad5 COVID-19 vaccine candidate, which shows memory T-cell recall from patients previously infected with SARS-CoV-2 virus. The ability to stimulate SARS-CoV 2 specific T-cells, which recognize the N and S proteins, is a "crucial" part of the novel design of ImmunityBio's vaccine candidate. The antibody- and T cell-based vaccine seeks both to provide protection for the uninfected population and also the potential to clear virally infected cells in infected subjects. It is unclear how long antibodies may provide protection. With the production of both antibodies and T cells, the potential exists for long-term, durable immunity. The results of this study were published in medRxiv. ImmunityBio's vaccine candidate targets both the spike and nucleocapsid proteins of SARS-CoV-2 to activate a multi-pronged attack by the immune system. This is distinct from most vaccine candidates currently in late-stage clinical trials, which target S alone. Recent reports suggest that antibodies to S may be vulnerable to reduced effectiveness because of emerging new mutations, as well as uncertainty over the longevity of the antibody response over time. The hAd5 bivalent COVID-19 vaccine induces T cell immunity and could provide long-term protection against the virus as the antibodies wane over time. An additional distinctive feature of the ImmunityBio vaccine candidate design is its use of a second-generation human adenovirus serotype 5 that has been shown to effectively deliver antigens even in the presence of preexisting adenovirus immunity which is present in up to roughly 60% of the population. Under the terms of a definitive agreement announced on August 24, 2020, ImmunityBio and its affiliate NantKwest agreed to share equally the costs of development, manufacturing, marketing and commercialization of the products each is developing related to COVID-19, including the hAd5 vaccine candidate. Should a product be commercialized successfully, the companies have agreed to a 60-40 percentage split of net profits, with the larger share going to the company that developed the product. The agreement also details the structure of shared governance of the joint collaboration.
CRVS

Hot Stocks

09:06 EST Corvus Pharmaceuticals completes enrollment in Phase 1 study of CPI-006 - Corvus Pharmaceuticala announced that it has completed patient enrollment in its Phase 1 study investigating the potential for CPI-006 to provide a novel immunotherapy approach for hospitalized patients with COVID-19. This novel immunotherapy may provide a therapeutic benefit from the activation of a polyclonal antibody response to the SARS-CoV-2 virus and the induction of long term immunity through active immunization. Updated data from the study is being presented this week in a poster presentation and an oral presentation at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting. The oral presentation will take place on Friday, November 13 at 12:15 pm ET as part of Session 301, which is titled "Hot Topic Symposium: COVID-19 and Cancer." Based on the study data to-date, the Company plans to initiate a pivotal, randomized, double blind study of CPI-006 in hospitalized COVID-19 patients in December with results expected around mid-2021. The data presented at SITC include results from 22 patients enrolled in the Phase 1 study utilizing a cut-off date of November 4, 2020. This includes enrollment in all four dosing cohorts of the study (0.3, 1.0, 3.0 and 5.0 mg/kg). All patients received a single dose of CPI-006 administered via a 5-10 minute intravenous (IV) infusion. The median age of the patients was 58 years (range 23-76 years). All of the patients had comorbidities that increased their COVID-19 risk including diabetes, coronary disease, hypertension, obesity, chronic kidney disease, chronic lung disease and/or cancer. 95% of patients were from minority populations that are at high risk of COVID-19 complications. The key highlights from the presentation include: Results Support the Immune Enhancing Role of CPI-006 in COVID-19: All patients had relatively low titers of anti-SARS-CoV-2 antibodies at the time of hospitalization despite having varying durations of prior COVID-19 symptoms from 1-21 days (median 5 days); all patients had a confirmed COVID-19 diagnosis by positive PCR nasal swab testing. All evaluable patients had prompt anti-SARS-CoV-2 antibody responses within 7 days of administration of CPI-006 at all dose levels. All patients recovered and were discharged from the hospital at a median of 4 (range 2-23) days. As of the November 4, 2020 cut-off date, there were no drug-related toxicity or safety issues reported. Antibody Response Results: Four of four evaluable patients that received the 0.3 mg/kg dose had sustained high titers of IgG antibodies to trimeric spike (TS) protein out to 84+ days (one patient 100+ days), without evidence of diminution of response. In these patients, IgM antibody titers peaked at 28-56 days and remained elevated out to 84+ days. Similar trends were seen in IgG and IgM antibody response to receptor binding domain (RBD). The geometric mean titers (GMT) for the 0.3, 1.0 and 3.0 mg/kg cohorts are shown in the charts below. A dose response was observed comparing the 3.0 and 1.0 mg/kg dose to the 0.3 mg/kg dose. Higher and more sustained titers of both IgG and IgM to both spike protein and RBD were seen out to 56 days when comparing the 1.0 to 0.3 mg/kg doses. The IgM responses were noteworthy for the sustained prolonged elevation.Antibody responses from 3.0 and 5.0 mg/kg doses appeared similar to the 1.0 mg/kg dose, but the follow up period for such doses was shorter as of the cut-off date. In viral neutralization assays, three of three patients developed anti-viral antibody responses out to day 56 that blocked infectivity of receptor bearing cells in a pseudovirus neutralization assay. Memory B cells were elevated in 6 of 6 tested patients following treatment with CPI-006. Memory T effector cells were also elevated following treatment and produced interferon-gamma and interleukin-2 in response to SARS-CoV-2 antigen consistent with antigen specific Th1 biasing.
TD

Hot Stocks

09:05 EST TD Bank Group targets net-zero emissions by 2050 - TD Bank Group announced its commitment to a global climate action plan, which includes a target to achieve net-zero greenhouse gas emissions associated with its operations and financing activities by 2050, aligned to the associated principles of the Paris Agreement. The Bank has also established dedicated teams to advise and support clients as they work to capture the opportunities of the low-carbon economy. The ambitious actions outlined today support the Bank's Environmental, Social and Governance strategy, which leverages TD's business, people and financial resources to help deliver sustainable economic prosperity.
MCD

Hot Stocks

09:05 EST McDonald's doubling down on digital, delivery and drive thru - McDonald's said: "The shift in customer behavior during COVID-19 has illustrated the competitive advantages of McDonald's. Delivery is booming and the use of the McDonald's app has surged as more and more customers are ordering and paying for their food on mobile devices. McDonald's 25,000 drive thru lanes worldwide have become an oasis for customers around the world. To unlock further growth, the Company will accelerate technology innovation so that the tens of millions of customers who interact with McDonald's each day can enjoy a fast, easy experience that fits their needs at the moment, whether a family dinner delivered to a doorstep or late-night fries from the drive thru." To transform its digital offerings across drive thru, takeaway, delivery, curbside pick-up and dine-in, the Company announced a new digital experience growth engine, "MyMcDonald's." Through the digital tools across this platform, McDonald's will offer customers the fast and easy experiences they love and provide them with many reasons to keep coming back. Customers will receive tailored offers, be able to participate in a new loyalty program and easily order and receive McDonald's food through the channel of their choice. One key component of "MyMcDonald's" starts in the coming weeks in the Phoenix area in the U.S. with a pilot of a new loyalty program. The Company expects digital sales to exceed $10 billion or nearly 20% of Systemwide sales across its top six markets in 2020. In the past three years, McDonald's has expanded the number of restaurants that offer delivery nine-fold, to about 28,000 restaurants. Building on this progress means enhancing the delivery experience for customers. This includes the ability to order on the McDonald's app, which is already available in several markets around the world, and optimizing operations with a focus on speed and accuracy. McDonald's will maximize the advantages of its strong drive thru presence by testing new concepts and technology to make the customer experience even faster. This includes innovations to provide a faster, more convenient experience such as automated order taking; a new drive thru express pick-up lane for customers with a digital order; and a restaurant concept that offers drive thru, delivery and takeaway only. In addition, the Company will build on its drive thru advantage as the vast majority of new restaurants in the U.S. and International Operated Markets will include a drive thru.
CRBP

Hot Stocks

09:04 EST Corbus Pharmaceuticals presents additional data from RESOLVE-1 study - Corbus Pharmaceuticals presented additional data from the RESOLVE-1 Phase 3 study of lenabasum for the treatment of systemic sclerosis. Summary of findings: Modified intent-to-treat population (n = 363): Stable doses of background immunosuppressant therapies were allowed in both lenabasum and placebo arms, reflecting current clinical practice. 84% of RESOLVE-1 subjects were on background immunosuppressant therapies. As previously reported, median American College of Rheumatology Combined Response Index for Systemic Sclerosis (ACR CRISS) scores at Week 52 were 0.888 versus 0.887, for lenabasum 20 mg twice daily (n = 120) versus placebo (n = 123). Placebo group (n = 123): Unprecedented improvement was seen in the placebo group in subjects who were concurrently receiving stable doses of background immunosuppressant therapies, especially subjects in their first two years on these therapies. Subjects treated with background mycophenolate had the greatest improvement over the one-year RESOLVE-1 study. Post-hoc analyses of lenabasum 20 mg twice daily group compared to placebo group: In subjects receiving established background immunosuppressant therapies (greater than 2 years duration at baseline), lenabasum treatment (n = 38) versus placebo (n = 26) was associated with reduced decline in forced vital capacity (FVC) at one year, measured in milliliters (-21 mL versus -170 mL, nominal P = 0.048) or percent predicted (-0.4% versus -4.6%, nominal P = 0.039). Data from these subjects were also categorized as follows: FVC % decline (worsening by more than -5%), stable FVC % (values within 5% of baseline value) and improved FVC % (improvement more than 5%). Lenabasum 20 mg twice daily was associated with a lower likelihood of a decline (19% lenabasum versus 50% placebo), greater likelihood to have stable FVC % predicted (64% lenabasum versus 35% placebo), and similar likelihood in improvement (17% lenabasum versus 15% placebo, nominal P = 0.035). In a subset of these subjects with diagnosed interstitial/restrictive lung disease (ILD), lenabasum 20 mg twice daily was associated with numerically reduced decline in FVC at one year (-14 mL versus -121 mL and -0.3% versus -3.5%), lenabasum (n = 32) versus placebo (n = 20). ILD was identified by fibrosis on chest x-ray or computerized tomography of the lungs or baseline FVC less than 80% predicted. Safety findings: Lenabasum was safely administered and well tolerated in this study, with no new safety findings. Dizziness (18.3% lenabasum versus 4.9% placebo) and dry mouth (5.0% lenabasum versus 1.6% placebo) were among adverse events that occurred in greater than or equal to 3% more subjects in the lenabasum 20 mg twice daily group versus the placebo group. No evidence of lenabasum-associated immunosuppression was seen. The Company is continuing to analyze the data and will consider the potential for an additional study based on results of these analyses. Focusing on FVC in patients on established immunosuppressant therapies could address a key unmet need, and we believe represent a potential commercial opportunity. Lenabasum has been granted Orphan Drug designation and Fast Track designation for the treatment of systemic sclerosis from the U.S. Food and Drug Administration.
CMTL

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09:03 EST Comtech completes participation in U.S. Army's network modernization exercise - Comtech Telecommunications announced that its Mission-Critical Technologies group, through its Maryland-based subsidiary, Comtech Mobile Datacom Corporation, which is part of Comtech's Government Solutions segment, has completed participation in the U.S. Army's 2020 Network Modernization Exercise at Joint Base McGuire-Dix-Lakehurst in New Jersey. Observers noted that the Comtech BFT equipment performed well under a variety of real-world scenarios at the exercise. This technology supports the U.S. Army's Network Modernization efforts to maintain situational awareness during multi-domain operations. "Comtech's participation in NetModX shows the U.S. Army's continued interest in Comtech's innovations, which are intended to give our soldiers every communication advantage," said Fred Kornberg, Chairman of the Board and Chief Executive Officer of Comtech Telecommunications Corp. "Comtech remains committed to providing the U.S. Army and its soldiers with the most advanced technology, enabling them to successfully complete all their missions, even in contested environments."
MCD

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09:03 EST McDonald's unveils 'Accelerating the Arches' growth strategy
CMTL

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09:03 EST Comtech completes participation in U.S. Army's network modernization exercise - Comtech Telecommunications announced that its Mission-Critical Technologies group, through its Maryland-based subsidiary, Comtech Mobile Datacom Corporation, which is part of Comtech's Government Solutions segment, has completed participation in the U.S. Army's 2020 Network Modernization Exercise at Joint Base McGuire-Dix-Lakehurst in New Jersey. Observers noted that the Comtech BFT equipment performed well under a variety of real-world scenarios at the exercise. This technology supports the U.S. Army's Network Modernization efforts to maintain situational awareness during multi-domain operations. "Comtech's participation in NetModX shows the U.S. Army's continued interest in Comtech's innovations, which are intended to give our soldiers every communication advantage," said Fred Kornberg, Chairman of the Board and Chief Executive Officer of Comtech Telecommunications Corp. "Comtech remains committed to providing the U.S. Army and its soldiers with the most advanced technology, enabling them to successfully complete all their missions, even in contested environments."
RARE

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09:03 EST Ultragenyx to build large-scale gene therapy manufacturing facility - Ultragenyx Pharmaceutical announced that it plans to build a new large-scale gene therapy manufacturing facility in Bedford, Massachusetts. The new facility will enable in-house manufacturing of the Company's pipeline of clinical stage adeno-associated virus (AAV)- based gene therapies, including DTX301 for ornithine transcarbamylase (OTC) deficiency, DTX401 for glycogen storage disease type Ia (GSDIa), and UX701 for Wilson disease, as well as other preclinical programs. The company will continue to leverage some contract manufacturing organizations in addition to its own manufacturing facility. Ultragenyx will use both of its gene therapy manufacturing platforms at the new facility: the HeLa producer cell line (PCL) platform which enables large 2,000 liter commercial-scale manufacturing and yields high-quality product from a highly reproducible, highly scalable platform, and the Company's HEK293 transient transfection system. The planned Phase I facility will encompass 100,000 square feet and provide important internal capacity to develop and manufacture supply of Ultragenyx's gene therapies for both clinical stage and approved products. The facility will be able to support two independent manufacturing suites with a capacity of 30 runs per year. Construction of the new facility has begun and is expected to be complete in 2023. As the facility becomes fully operational, Ultragenyx expects to hire approximately 100 to 150 full-time employees, over a five-year period across a broad range of functions and skill sets, adding to their existing base of employees in Massachusetts. Ultragenyx already controls land and development rights for an additional 86,000 square feet of Phase II expansion on-site which could be used to double capacity if needed.
NKTX

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09:02 EST Nkarta announces preclinical update on NKX019 - Nkarta announced a preclinical update on NKX019, its investigational allogeneic cancer immunotherapy that uses donor-derived natural killer (NK) cells engineered with a membrane-bound form of IL15 and a chimeric antigen receptor (CAR) targeting the CD19 antigen. The data were presented today in a poster at the Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting entitled "Preclinical evaluation of NKX019, a CD19-targeting CAR NK Cell". Poster # 127. Highlights of the preclinical findings include: Cryopreserved NKX019 demonstrated potent, targeted anti-tumor activity in vitro and in vivo across different CD19-expressing cancer models for B cell lymphoma and acute lymphoblastic leukemia. Compared to non-engineered NK cell controls, the dosing of NKX019 resulted in increased treatment exposure and superior anti-tumor activity.Compared to T cells transduced to express a CD19 CAR, NKX019 demonstrated several advantages. NKX019 was more potent on a per cell basis than CD19 CAR T cells, with a more rapid onset of activity. Moreover, when exposed to tumor cells side-by-side with CAR19+ T cells, NKX019 produced significantly lower quantities of factors associated with cytokine release syndrome (CRS), a type of adverse event associated with approved CAR T cell therapies. The preclinical data support the potency, safety and tolerability profile of NKX019. In addition to the limited cytokine response of NKX019 in the presence of tumor cells, NKX019 cell killing was highly specific, confined to CD19+ cells when tested in bulk peripheral blood.
CLDX

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09:00 EST Celldex presents data from oncology portfolio - Celldex Therapeutics announced data from multiple presentations at the Society for Immunotherapy of Cancer's (SITC) 35th Anniversary Annual Meeting & Pre-Conference Programs (SITC 2020). An interim update from the Company's ongoing Phase 1 study of its CD40 agonist antibody, CDX-1140, and preclinical data from its AXL discovery program were presented at the meeting. In addition, the Phase 1 study design for the Company's bispecific candidate, CDX-527, which couples CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway, were also presented in a clinical trial in progress poster. Presentation Highlights CDX-1140 Presentation Highlights (Poster #405): CD40, expressed on dendritic cells and other antigen presenting cells, is an important target for immunotherapy, as it plays a critical role in the activation of innate and adaptive immune responses. CDX-1140 is a fully human agonist anti-CD40 monoclonal antibody that was specifically designed to balance good systemic exposure and safety with potent biological activity, a profile which differentiates CDX-1140 from other CD40-activating antibodies. CDX-1140 is currently in a Phase 1 dose escalation and expansion study. The study includes monotherapy and combination cohorts, including with CDX-301, Celldex's dendritic cell growth factor, with the PD-1 inhibitor pembrolizumab in patients who have progressed on checkpoint therapy and in combination with standard of care chemotherapy (gemcitabine and nab-paclitaxel) in first line metastatic pancreatic cancer. Prior data presented at SITC 2019 established the maximum tolerated dose (MTD) and recommended dose for continued study at 1.5 mg/kg-one of the highest systemic dose levels in the CD40 agonist class. The update presented at SITC 2020 focused on patients treated at the MTD from both the monotherapy (n=25) and CDX-301 (n=16) combination cohorts. In addition, preliminary safety data from the combination cohort with pembrolizumab (n=9; 4 at 0.72 mg/kg and 5 at 1.5 mg/kg CDX-1140) were also presented. CDX-1140 monotherapy and in combination with CDX-301 or pembrolizumab was generally well tolerated with mostly grade 1 or grade 2 drug related adverse events. Clinical activity both as a monotherapy and in combination with CDX-301 has been previously reported for CDX-1140 at varying doses, including an unconfirmed partial response (uPR) and tumor cavitation. At SITC 2020, analysis was focused on patients treated at the MTD and recommended dose of 1.5 mg/kg. 41 patients had been treated at the 1.5 mg/kg dose at the time of data cutoff; 29 patients had post-treatment scans performed and five patients had not reached their first post-treatment response assessment. Activity at 1.5mg/kg dose of CDX-1140 to date included: An ongoing (6+ months) complete response (CR) in a patient with follicular lymphoma treated with CDX-1140 in combination with CDX-301; Notable tumor shrinkage and/or necrosis in 6 patients with squamous cell head and neck cancer (SCCHN), including extensive tumor cavitation/necrosis of a large baseline protruding neck mass associated with decreased tumor pain in a patient; and, Stable disease (n=10) for 11 to 32 weeks. CDX-1140 at the recommended dose of 1.5 mg/kg provided good systemic exposure that enhanced the distribution into tissues and tumor and resulted in marked changes in the tumor microenvironment (TME) consistent with a more inflammatory and less immunosuppressive state as demonstrated by gene expression analysis. Interferon signaling and cytotoxicity pathways were most highly upregulated, while immunosuppression via TGFb signaling and metastatic pathways were downregulated, marking the first clear demonstration in patients of biological activity within the TME for a systemically administered agonist anti-CD40 mAb. Pre-treatment of patients with CDX-301 greatly increased the number of circulating dendritic cells prior to CDX-1140 administration and peripheral blood mononuclear cells (PBMCs) isolated from CDX-301 pretreated patients were more responsive to CDX-1140 than PBMCs from non-pretreated patients. Ongoing cohorts: The combination of CDX-1140 with pembrolizumab has completed the safety run-in and expansion cohorts in patients with checkpoint-refractory squamous cell head and neck cancer and non-small cell lung cancer have initiated. The combination of CDX-1140 with gemcitabine/nab-paclitaxel recently opened to enrollment to patients with previously untreated metastatic pancreatic adenocarcinoma. Data updates from these cohorts are expected in the first half of 2021.
ADXS MRK

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08:58 EST Advaxis presents data from ongoing ADXS-503 Phase 1/2 trial - Advaxis announced the presentation of data from the Company's ongoing Phase 1/2 study evaluating ADXS-503 as a monotherapy and in combination with KEYTRUDA, Merck's anti-PD-1 therapy in non-small cell lung cancer at the 2020 Society for Immunotherapy of Cancer Annual Meeting. ADXS-503 is the first drug construct from the Company's ADXS-HOT off-the-shelf, cancer-type specific, immunotherapy program which leverages Advaxis' proprietary Lm technology platform to target hotspot mutations that commonly occur in specific cancer types as well as other proprietary, tumor-associated antigens. The data presented across three cohorts; Part A monotherapy, Part B combination with KEYTRUDA(R) and Part C combination with KEYTRUDA in the first line setting for patients with NSCLC with PD-L1 expression greater than or equal to 1% or who are unfit for chemotherapy, together, demonstrate that ADXS-503 was safe and well tolerated, and may restore or enhance sensitivity to checkpoint inhibitors as an off-the-shelf, neoantigen immunotherapy. Key presentation highlights: Poster presentation titled, "Phase 1/2 Study of an Off-the-Shelf, Multi-Neoantigen Vector Alone and in Combination with Pembrolizumab in Subjects with Metastatic Non-Small Cell Lung Cancer". ADXS-503 alone and in combination with Pembrolizumab appeared safe and tolerable. There were no added toxicities from combining ADXS-503 with Pembrolizumab In Part A, ADXS-503 alone achieved stable disease in 50% of heavily pre-treated patients including prior treatment with checkpoint inhibitors in all but one patient In Part B, the overall response rate and disease control rate suggest that adding on ADXS-503 after immediate prior progression on Pembrolizumab may re-sensitize or enhance response to Pembrolizumab. The first two patients treated in the Part B that had achieved SD and PR have now lasted 10 months. In Part B, one patient with squamous histology also achieved stable disease, suggesting this regimen may be broadly applicable across NSCLC/ Biomarker data from 9 patients to date, 6 from Part A and 3 from Part B, show: Activation of cytotoxic- and/or memory-CD8+ T cells in patients treated with monotherapy and in combination therapy. 100% efficient priming by ADXS-503 with generation of CD8+ T cells against neoantigens in the vector as well as antigen spreading observed. Patients with known KRAS mutations in tumor samples have achieved stable disease in the study, including KRAS G12D in 2 out of 6 patients in Part A and KRAS G12V in 1 out of 3 in Part B DL1. Mutational analysis is ongoing across all patients.
GNCA

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08:56 EST Genocea presents GEN-099 results, update on GEN-011 program - Genocea Biosciences presented four posters that collectively validate the company's unique and differentiated approach to identifying clinically meaningful immunotherapy targets at The Society for Immunotherapy of Cancer 35th Anniversary Annual Meeting taking place virtually November 9th - 14th. In follow up to data shared at the European Society for Medical Oncology Virtual Congress 2020, the company shared expanded clinical and immunogenicity findings from Part B of its ongoing GEN-009 Phase 1/2a trial, which evaluates GEN-009, Genocea's neoantigen vaccine, in combination with PD-1 inhibitors in advanced cancers. Posters 390 and 413 outline the clinical and immune responses elicited by GEN-009 in 16 checkpoint inhibitor therapy sensitive and resistant patients. Poster 413 was a highly scored abstract selected for a "Poster Walk." Of the nine CPI-sensitive patients, three patients experienced a novel reduction in tumor volume post-GEN-009 dosing and achieved independent RECIST responses after vaccination, including 2 PRs and 1 CR. Five additional CPI-sensitive patients have shown disease control post-vaccination for up to 11 months. Within the CPI-resistant population, five of seven patients appear to have stabilized disease lasting up to seven months. GEN-009 elicited strong anti-tumor immune responses with both CD4+ and CD8+ T cell responses observed at day 50 post-vaccination and with peak ex vivo responses occurring Day 92. Early data from two patients tested so far show a complete absence of circulating tumor DNA by day 50, which is consistent with a vaccine clinical effect. There was also emerging evidence of epitope spreading in patients who successfully responded to therapy. GEN-009 was safe and well tolerated. One distinguishing feature of Genocea's proprietary ATLAS technology is its ability not only to identify the stimulatory neoantigens to include in GEN-009 and GEN-011, but also to reveal Inhibigens - peptides that elicit T cell responses with the capacity to compromise anti-tumor immunity. Poster 526 delves further into the biology of Inhibigen-specific responses and reveals important insights that add to the company's growing body of knowledge beyond data previously shared at the AACR Virtual Annual Meeting II. Findings in mice and humans confirmed the presence of Inhibigens in nearly every sample screened, and mouse data show the abrogation of anti-tumor activity in response to otherwise protective vaccines is associated with decreased CD4+ and CD8+ T cell, macrophage and dendritic cell infiltration into tumors. This outcome may be attributed to abolished cytokine activity in response to tumor-specific vaccine antigens. The data also show that vaccination with an Inhibigen renders CPI co-administration ineffective. Poster 149 highlights important advantages of GEN-011 over TIL and TCR-T therapies. GEN-011 has been developed with 100% manufacturing success at clinical scale via PLANET(TM), a process designed to deliver billions of NPTs for every patient. The 16 PLANET runs conducted to date have confirmed GEN-011 comprises over 98% of highly functional, non-exhausted T cells with a mean neoantigen breadth of response nearing 90% of intended targets. In contrast, recent reported data from TIL products showed responses to less than 10% of intended neoantigens. GEN-011 NPTs have an unparalleled breadth of neoantigen coverage, targeting up to 30 relevant antigens. The drug product also avoids pro-tumor Inhibigens that may hinder clinical responses and the PLANET process does not require extra surgery or viable tumor.
GRA

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08:56 EST 40 North Management proposes to acquire W.R. Grace for $60 per share in cash - In a regulatory filing, it was disclosed that on November 9, 40 North Management delivered a letter to the board of directors of W.R. Grace, pursuant to which 40 North Management and its affiliated investment funds have proposed to acquire the company for a price of $60.00 per share in cash. In connection with the proposed transaction, the funds will seek to obtain access to, and review, due diligence materials from the company and conduct discussions with the company regarding the terms of the proposed transaction. The funds may change the terms of the proposed transaction, determine to accelerate or terminate discussions with the company with respect to the proposed transaction, withdraw the proposed transaction, take any action to facilitate or increase the likelihood of consummation of the proposed transaction, or change their intentions with respect to any such matters, in each case at any time and without prior notice, the filing said. 40 North disclosed in the same filing that it holds a 14.9% stake in W.R. Grace.
VMD

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08:54 EST Viemed Healthcare appoints Sabrina Heltz to board of directors - Viemed Healthcare announced that Sabrina Heltz has joined the Board of Directors as an independent director. Following her career at BCBSLA, she served for four years at Ochsner Health Network as Chief Operations Officer and recently transitioned to an executive advisor, assisting the network in its strategy and operations to enable success in value based contracts offered by Medicare and commercial health plans.
GRA

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08:53 EST 40 North Management proposes to acquire W.R. Grace for $60 per share in cash
CUE

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08:53 EST Cue Biopharma announces presentations on CUE-101, CUE-100 series - Cue Biopharma announced three poster presentations highlighting the Company's clinical and pipeline progress at the Society for Immunotherapy of Cancer's 35th Anniversary Annual Meeting. The posters include a clinical update on CUE-101, the lead drug candidate from the IL-2 based CUE-100 series, and data supporting the potential of the Immuno-STAT platform to selectively engage and modulate targeted T cells within the body in a manner that can address a broad range of indications. Due to the abstract submission and acceptance dates for SITC, the poster highlighting progress on CUE-101 will only contain data updates through cohort 4. Members of the Cue Biopharma executive management team will provide further updates and details pertaining to patients from cohorts 4, 5 and 6 at the upcoming quarterly update call on November 17 at 4:30 p.m. EST. In addition, Cue Biopharma has recently received permission from the Clinical Safety and Review Committee to proceed with dose escalation to cohort 7 at 8 mg/kg. The SITC Presentations include: A phase 1 trial of CUE-101 a novel HPV16 E7-pHLA-IL2-Fc fusion protein in patients with recurrent/metastatic HPV16+ head and neck cancer: An ongoing multicenter, open-label, dose escalation Phase 1 trial is evaluating the safety, tolerability, anti-tumor response, pharmacokinetics and immunogenicity of CUE-101 as a monotherapy in patients with confirmed human papilloma virus positive recurrent/metastatic head and neck squamous cell carcinoma and HLA-A*02:01 serotype. Results from 19 participants who have received CUE-101 at doses ranging from 0.06 to 1 mg/kg demonstrate acceptable tolerability, favorable pharmacokinetics and preliminary pharmacodynamics signals that indicate selective activation of tumor-specific T cells, enabling dose escalation to the next level. CUE-100 series Immuno-STATs from concept to the clinic: Leveraging protein engineering to stimulate and selectively deliver affinity-attenuated IL-2 to antigen-specific T cells: In vitro and in vivo evaluation of CUE-100 series Immuno-STATs specific to different antigenic peptides demonstrated expansion of functional, oligoclonal, antigen-specific T cell repertoires with functional attenuation of the IL-2 components. CUE-100 series Immuno-STATs administered to human peripheral blood mononuclear cells selectively activated and expanded antigen-specific CD8+ T cells after primary stimulation and re-stimulation with antigenic peptides from HPV16, Wilms' tumor 1, melanoma antigen recognized by T cells 1, cytomegalovirus , influenza and HIV. In naive HLA-A*02 transgenic mice, CUE-100 series Immuno-STATs expanded CD8+ T cells, exhibiting a polyfunctional response upon challenge with peptide-presenting target cells. Immuno-STATs: Leveraging protein engineering to expand and track antigen-specific T cells in vivo: The potential modularity of the Immuno-STAT platform and ability to selectively deliver costimulatory, coinhibitory or cytokine signals and other modalities to primary T cells of defined specificity was observed through the use of a novel immuno-positron emission tomography imaging approach. PET-active radiolabels were installed on dimeric protein scaffolds comprising the core structure of the Immuno-STAT to visualize the in vivo localization of antigen-specific T cells. Results showed that HPV16-specific CD8+ T cells were localized to implanted HPV16-positive tumors in mice, and influenza A virus-specific CD8+ T cells were localized to the lungs of IAV-infected mice. HIV- and CMV-specific Immuno-STATs administered to immunodeficient mice intrasplenically engrafted with human PBMCs resulted in selective expansion of disease-relevant T cells in the spleen. These data represent the first report of the in vivo imaging of antigen-specific CD8+ T cell populations and in vivo antigen-selective expansion of human CD8+ T cells, which suggests the presence of Immuno-STAT biologics in the particular tumor or infected tissues where they act, eliciting selective activation and expansion of target T cells. These results suggest that, in addition to broad therapeutic applications, Immuno-STATs may also provide prognostic and diagnostic information.
GME

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08:50 EST GameStop reveals 2020 Black Friday deals - GameStop unveiled its 2020 Black Friday sales ad, revealing its holiday deals on the hottest video games, consoles, accessories, and pop culture collectibles items such as board games, statues, pop vinyl figures and apparel items. The Black Friday sale offers will be available on www.gamestop.com and through the GameStop mobile app on Nov. 25, at 8 p.m. CST, and in-store at GameStop's more than 3,300 U.S. store locations starting Nov. 27, Nov. 28, and Nov. 29.
MCD

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08:50 EST McDonald's to collect remainder of deferrals in Q4, Q1
GALT

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08:50 EST Galectin Therapeutics expects cash to fund operations through at Dec. 31 - As of September 30, 2020, the Company had $32.6 million of cash and cash equivalents. The Company also has a $10 million unsecured line of credit, under which no borrowings have been made to date. The Company believes it has sufficient cash, including availability under the line of credit, to fund currently planned operations and research and development activities through at least December 31, 2021. The Company expects that it will require more cash to fund operations after December 31, 2021 and believes it will be able to obtain additional financing as needed. Currently, we expect to require an additional approximately $40 million to cover costs of the trial to reach the planned interim analysis estimated to occur in the second quarter of 2023 along with drug manufacturing and other scientific support activities and general and administrative costs. These costs will require additional funding. There can be no assurance that we will be successful in obtaining financing to support our operations beyond December 31, 2021, or, if available, that any such financing will be on terms acceptable to us.
ORN

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08:48 EST Orion Group announces contract awards totaling approximately $52M - Orion Group Holdings announced contract awards totaling approximately $52 million. The Company's Concrete segment has been awarded three separate contracts to provide concrete and associated paving services for projects in Texas. All three projects call for the construction of large distribution facilities, two of which are located in the Houston area and are valued at approximately $21 million and $17 million, while the third project, valued at approximately $14 million, is in the Dallas Fort Worth market. Work on all three projects is due to begin before the end of this year and is planned to be completed in the first half of 2021. "These are the types of projects at which we excel and represent a true testament to our team and our reputation as one of the leading providers of concrete construction services in our markets," said Mark Stauffer, Orion's President and Chief Executive Officer.
CCDBF

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08:48 EST CCL Industries expands in Malaysia - CCL Industries announced it has signed a binding agreement to acquire Super Enterprises Printing, based in Kuala Lumpur with a second manufacturing operation in Guangzhou, China. SEP is a leading supplier of decorative panels, liquid crystal & touch screen display covers and in-mould decorated components for the consumer electronics and automotive sectors across Asia. For the trailing twelve months ending September 30, 2020, sales were $26.4 million, with adjusted EBITDA estimated at $3.0 million. The approximate $20.0 million purchase price includes two buildings housing operations in Kuala Lumpur. Closing is planned before the end of the year, at which time the new business will trade as CCL Design.
IFNNY GTAT

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08:47 EST Infineon expands supply base for silicon carbide with GT Advanced - Infineon Technologies AG (IFNNY) and GT Advanced Technologies (GTAT) have signed a supply agreement for silicon carbide boules. The contract has an initial term of five years. With this supply contract, the German semiconductor manufacturer adds a further element to secure its growing base material demand in this area. SiC is the basis for power semiconductors that are particularly efficient, robust, and cost-effective at the system level. Under the name CoolSiC Infineon now already markets the industry's largest product portfolio for industrial applications and is rapidly expanding its offering towards consumer and automotive products.
MCD

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08:46 EST McDonald's: October U.S. comp growth in 'strong mid-single digits'
EVLO

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08:46 EST Evelo Biosciences presents preclinical data for EDP1908 - Evelo Biosciences announced preclinical data for EDP1908, its extracellular vesicle product candidate for the treatment of cancer, in a poster presentation at the Society for Immunotherapy of Cancer's 35th Anniversary Annual Meeting. The data show that orally administered EDP1908 had anti-tumor effects that surpassed both checkpoint inhibitors and orally delivered microbial strains in preclinical models. In the preclinical study presented at SITC, tumor-bearing mice were treated with ascending doses of either oral EDP1908 or the parental microbial strain of EDP1908, or with anti-PD-1. Treatment with EDP1908 resulted in superior tumor growth control versus either the parent microbial strain or anti-PD-1 therapy, with a dose-dependent reduction of tumor growth. The effects were also at least comparable to those reported in the literature for intra-tumoral immune stimulators. Treatment with EDP1908 activated IFNgamma-positive cytolytic and helper lymphocytes, dendritic cells, and interferon gamma-induced protein 10 in the tumor microenvironment. Fluorescent biodistribution analysis showed that EDP1908 was not detected outside the gastrointestinal tract. These data suggest that EDP1908 activates innate immunity by acting locally on host immune cells in the gut to trigger distal immune responses within the tumor microenvironment, with no apparent adverse safety or tolerability effects preclinically. EDP1908 is now in preclinical and manufacturing development
MCD

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08:45 EST McDonald's still sees FY20 CapEx about $1.6B
RUBY

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08:45 EST Rubius Therapeutics presents preclinical data for RTX-240 - Rubius Therapeutics announced the presentation of new preclinical data supporting its lead clinical oncology program, RTX-240, at the Society for Immunotherapy of Cancer's Annual Meeting. The meeting is being held virtually from November 9-14, 2020. RTX-240 is an allogeneic, off-the-shelf Red Cell Therapeutic that is engineered to mimic the human immune system by stimulating adaptive and innate immunity to generate an anti-tumor immune response. Rubius Therapeutics is currently enrolling patients in the Phase 1/2 clinical trial of RTX-240 for the treatment of patients with relapsed/refractory or locally advanced solid tumors. In addition, RTX-240 is being evaluated in a second Phase 1 arm of the clinical trial for the treatment of patients with relapsed/refractory acute myeloid leukemia. RTX-240, an Allogeneic Engineered Red Blood Cell Expressing 4-1BBL and IL-15TP, Promotes NK Cell Functionality In Vitro and In Vivo: RTX-240 is an allogeneic, off-the-shelf cellular therapy product candidate that is engineered to simultaneously present hundreds of thousands of copies of the costimulatory molecule 4-1BBL and IL-15TP on the cell surface in their native forms. RTX-240 is designed to stimulate innate and adaptive immunity by activating NK cells and T cells inside the patient's body to generate an anti-tumor immune response. RTX-240 preclinical data demonstrated: RTX-240 led to increased CD8 T cell and NK cell expansion and activation in vitro compared to the combination of a 4-1BB agonist antibody plus recombinant IL-15 which was directly correlated with the percentage of 4-1BBL and IL-15TP expressed on the cell surface; RTX-240 expanded CD56dim NK cells, a cell population with high cytotoxicity; RTX-240 promoted NK cell-killing of a myeloid leukemia cell line, K562, and this was accompanied by increased NK cell degranulation and activation; A murine surrogate for RTX-240, mRBC-240, promoted significant expansion of CD8 T cells and NK cells in vivo in a murine model of colorectal cancer; mRBC-240 demonstrated potent antitumor activity in a B16F10 melanoma model that was directly correlated with the expansion of terminally differentiated NK cells in the tumors/
CDAK

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08:43 EST Codiak presents data from programs using engEX platform - Codiak BioSciences announced that preclinical data from programs using its engEx Platform are being presented this week at the 35th Annual Meeting of the Society for Immunotherapy of Cancer. Results from multiple studies highlight the potential of Codiak's precision engineered exosomes to direct pharmacological payloads to specific cells and to achieve enhanced immune mediated anti-tumor activity with an expanded safety margin. Exosomes are naturally occurring, extracellular vesicles that have evolved as an intercellular messenger system to protect and deliver functional macromolecules between cells. Utilizing its engEx Platform, Codiak can engineer exosomes with distinct properties, load them with various types of therapeutic molecules and alter tropism so they reach specific cellular targets. Codiak is developing exosome therapeutic candidates to target multiple pathways throughout the body to treat various forms of cancer, neurological diseases, and infectious diseases. The company initiated clinical trials in September 2020 for two engineered exosome candidates, exoIL-12 and exoSTING, for the treatment of lymphoid and solid tumors. Tumor-Retained Pharmacology and Superior In Vivo Efficacy of exoIL-12 Widens the Therapeutic Window: exoIL-12 is a novel exosome therapeutic candidate engineered to display active IL-12 on the surface of the exosome. exoIL-12 facilitates potent local pharmacology at the injection site with precisely quantified doses with minimal systemic exposure. The current studies extend observations from previous presentations demonstrating tumor retention and increased tumor growth inhibition across multiple mouse models. Additionally, these data demonstrate significant remodeling of the tumor microenvironment and confirm tissue-retained pharmacology in non-human primate models, thereby widening the therapeutic window for this potent cytokine. Highlights from the data presented at SITC 2020 include: exoIL-12 showed 15-fold improved retention at the injection site and demonstrated four-fold prolonged and improved interferon gamma production as compared to recombinant IL-12. exoIL-12 was ~100 fold more potent in tumor growth inhibition than rIL-12. Complete responses were observed in 63% of mice treated with exoIL-12 compared to 0% in mice treated with an equivalent dose of rIL-12. exoIL-12 showed dramatic change in the tumor microenvironment as evidenced by ~8-fold increase in cytotoxic T-cell infiltration and ~150-fold increase in M1 macrophage recruitment. In the non-human primates, exoIL-12 demonstrated tissue-localized pharmacology, local induction of IFNg, and lack of systemic exposure. Engineered Exosomes Allow for Targeting of Multiple Immune Cell Types: Results from multiple in vitro and in vivo studies demonstrated the ability of the engEx Platform to alter cellular tropism and increase functional payload delivery in multiple immune cell types. Exosomes engineered to display several types of targeting domains on the surface exhibited greater association with the target cell types, including dendritic cells, T cells and B cells, both in vitro and in vivo. Notably, exosomes engineered to display scFabs targeting Clec9A resulted in increased uptake in Clec9A positive DCs that are important in generating anti-tumor immune responses. Anti-Clec9A exosomes loaded with a STING agonist induced pro-inflammatory cytokines in primary mouse DCs at levels up to 15-fold greater than an untargeted control exosome. Preliminary in vivo data show that intra-tumorally administered anti-Clec9A exosomes reduced the required STING agonist dose by 10-fold to control tumor growth and induced greater immune responses against tumor-associated antigens when compared to untargeted controls.
MCD

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08:42 EST McDonald's U.S. comp sales were positive in October
IMMP

Hot Stocks

08:41 EST Immutep announces Australian patent grant for IMP701 antibody - Immutep announces the grant of patent no. 2015229103 entitled "Antibody molecules to LAG-3 and uses thereof" by the Australian Patent Office. This new Australian patent builds on the corresponding US patents announced in March 2018 and July 2020, a European patent announced in November 2019, and a Japanese patent announced in September 2019. The Australian patent is directed to LAG525, pharmaceutical compositions comprising LAG525, the use of LAG525 in the treatment of cancer or infectious disease, nucleic acid molecules that code for the LAG525 antibody, and to various combination treatments comprising LAG525 and a second therapeutic agent or procedure. LAG525 is a humanised form of Immutep's IMP701 antibody which is out-licensed to Novartis AG. The patent is co-owned by Novartis AG and Immutep S.A.S. and will expire on 13 March 2035.
KBLM

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08:40 EST KBL Merger Corp. IV completes acquisition of 180 Life Sciences - KBL Merger Corp. IV announced the successful completion of its acquisition of 180 Life Sciences Corp., a clinical-stage biotechnology company with its lead indication in Phase 2b/3, focused on the development of novel drugs that fulfill unmet needs in inflammatory diseases, fibrosis and pain. In connection with the closing of the merger, KBLM issued 17,500,000 shares of common stock to the stockholders of 180 Life Sciences, of which 1,049,999 shares were deposited in an escrow account and subject to forfeiture for indemnification claims, and of which 1,981,496 shares are issuable to the holders of the existing exchangeable shares of CannBioRex Purchaseco ULC and/or Katexco Purchaseco ULC, Canadian subsidiaries of 180 Life Sciences. The issuance of the shares of common stock to the stockholders of 180 Life Sciences was registered on an effective registration statement on Form S-4 that the Company filed with the Securities and Exchange Commission on November 12, 2019 and that was declared effective on October 9, 2020. Following the merger, 180 Life Sciences shall survive as a wholly-owned subsidiary of KBLM. Prior to the closing of the merger, 180 Life Sciences Corp. changed its name to 180 Life Corp., and KBL Merger Corp. IV changed its name to 180 Life Sciences Corp. As used in this press release, references to KBL Merger Corp. IV refer to the Company and references to 180 Life Sciences Corp. refer to 180 Life Sciences. As a result of the merger, the units and rights of KBL Merger Corp. ceased trading, and the shares of its common stock and warrants will trade on the Nasdaq Capital Market under the ticker symbols "ATNF" and "ATNFW," respectively, starting on or about November 9, 2020.
SAMA

Hot Stocks

08:38 EST Schultz Special Purpose Acquisition, Clever Leaves revise transaction terms - Schultze Special Purpose Acquisition Corp. and Clever Leaves International jointly announced that they have amended their definitive agreement, which was entered into on July 25, 2020, pursuant to which a newly formed holding company, Clever Leaves Holdings, will acquire SAMA and Clever Leaves and is anticipated to become a NASDAQ-listed public company trading under the ticker symbol "CLVR". Under the amended terms, the initial expected enterprise value has been reduced to $206 million from $255 million and the minimum cash condition for SAMA has been reduced to $26 million from $60 million. Additionally, the cash consideration payable to certain Clever Leaves' shareholders at closing has been amended, thereby increasing the equity rollover consideration of the transaction to approximately 97% while Schultze Special Purpose Acquisition Sponsor, LLC agreed to restructure its' equity ownership to better align with the capital retained at closing. In connection with these revised terms, institutional investors have committed over $10 million through a private placement to be funded at closing of the Business Combination. Additionally, select SAMA stockholders have agreed not to redeem their shares held thereby providing a path to over $16 million of additional committed capital1 and thus having adequate capital to consummate the transaction. When including SAMA's cash in trust, the parties expect to have over $80 million of cash on its balance sheet following closing. The amendments to the Business Combination Agreement have been unanimously approved by the Boards of Directors of both SAMA and Clever Leaves and the transaction remains on track to close in the fourth quarter of 2020, subject to the Registration Statement being declared effective by the SEC, in addition to other regulatory and shareholder approvals, as well as customary closing conditions.
ONCS

Hot Stocks

08:38 EST OncoSec announces new data from KEYNOTE-695 Phase 2b clinicial trial - OncoSec Medical announced new positive interim data from its KEYNOTE-695 registration-enabled Phase 2b clinical trial evaluating TAVO, a DNA plasmid-based interleukin-12, or IL-12, in combination with KEYTRUDA in rigorously defined anti-PD1 checkpoint resistant metastatic melanoma patients. TAVO + KEYTRUDA led to a 30% ORR in the first 54 out of 100 planned patients. This interim investigator assessed ORR is much higher than the primary efficacy endpoint for the study, which is a 20% ORR determined by blinded independent review. The data were selected for a Poster Walk discussion and will be additionally presented in the virtual Poster Hall on Wednesday, November 11 and Friday November 13 and as part of a Company Symposium on November 11th at the Society for Immunotherapy of Cancer's 35th Anniversary Annual Meeting.
NFIN

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08:37 EST Netfin Acquisition announces results of shareholder redemptions - Netfin Acquisition Corp announced that less than 3% of its public shares were submitted for redemption in connection with the Company's previously announced business combination with Triterras Fintech. As a result, approximately $250 million will remain in Netfin's trust account and be released upon the closing of the business combination. In addition, Netfin reminds its shareholders to vote in favor of the proposed business combination and other proposals to be presented to shareholders at the Extraordinary General Meeting scheduled to occur at 9:00 AM Eastern time on November 10, 2020. Shareholders can submit their proxy votes over the Internet by accessing the Internet website specified in the proxy card or voting instruction form provided to them. The business combination is expected to close as soon as practicable after the special meeting, subject to the satisfaction of the applicable closing conditions. Upon the closing of the business combination, the combined company will be renamed "Triterras, Inc." and its ordinary shares will trade on The Nasdaq Stock Market under the ticker symbol "TRIT".
RCEL

Hot Stocks

08:37 EST Avita Medical enters collaboration with Houston Methodist Research Institute - AVITA Therapeutics announced a preclinical research collaboration pairing AVITA Therapeutics' proprietary Spray-On Skin Cells with Houston Methodist Research Institute's expertise in reversing cellular aging. The project seeks to establish proof-of-concept for the development of a novel approach to reverse aging and rejuvenate skin, with the potential for broader applicability, such as scar revision and wound healing. AVITA Therapeutics has also entered into an Option Agreement to negotiate an exclusive, worldwide license to this patented technology for skin applications, as well as first right of negotiation to technologies emerging from the collaboration for potential further development and commercialization. Under the Sponsored Research Agreement, AVITA Therapeutics will gain access to Houston Methodist's innovative technologies, including an RNA-based approach to rejuvenate human cells. Houston Methodist has studied the use of telomerase to lengthen the ends of chromosomes, which act as molecular clocks in cells and progressively shorten with age. Through that research, the Houston Methodist team has established a proof-of-concept that their RNA technology reverses aging of cells, including those derived from patients with progeria. During the research collaboration, AVITA Therapeutics and Houston Methodist Research Institute will explore applications of this RNA technology to rejuvenate skin by reversing aging mechanisms. The initial research program is expected to run 18 months, followed by further work to develop a data package enabling regulatory submission, targeting an Investigational New Drug application
GBT

Hot Stocks

08:35 EST Global Blood Therapeutics announces new employment inducement grants - Global Blood Therapeutics announced that on November 1, 2020, the compensation committee of GBT's board of directors granted 10 new employees options to purchase an aggregate of 19,500 shares of the company's common stock with a per share exercise price of $52.88 and restricted stock units for an aggregate of 89,675 shares of the company's common stock. These awards were made under GBT's Amended and Restated 2017 Inducement Equity Plan. Pursuant to the Plan, the exercise price for the 19,500 shares of the company's common stock was the closing trading price on October 30, 2020, because there was no closing trading price on November 1, 2020. The above-described awards were each granted as an inducement material to the employees entering into employment with the company in accordance with NASDAQ Listing Rule 5635(c)(4), and were granted pursuant to the terms of the Plan. The Plan was adopted by GBT's board of directors in January 2017 and has been amended and restated from time to time.
MLND

Hot Stocks

08:35 EST Millendo Therapeutics reports Q3 EPS (34c), consensus (46c) - Cash, cash equivalents and restricted cash were $43.8 million at September 30, 2020, compared to $63.5 million at December 31, 2019. "We continue to advance MLE-301 as a potential alternative to hormone replacement therapy for the treatment of vasomotor symptoms (VMS) related to menopause, and were pleased to initiate our Phase 1 clinical trial in the 3rd quarter," said Julia C. Owens, President and Chief Executive Officer of Millendo Therapeutics. "MLE-301 is a priority program for Millendo, given the broader industry excitement around its potential to address a large unmet need, along with a refocusing of our internal pipeline efforts. With over 20 million women in the United States suffering from menopausal VMS, and with symptoms lasting on average over seven years, there is still a critical need for a treatment that has the efficacy of hormone replacement therapy without increased risks of cancer or cardiovascular disease."
XNET

Hot Stocks

08:35 EST Xunlei announces cooperation to offer joint cloud storage services - Xunlei announced that the Company established cooperation with Shijilong Information Network Co. on November 6, 2020 to develop joint cloud storage services. Shijilong is a wholly-owned subsidiary of China Telecom. According to this cooperation, Xunlei will leverage its technological expertise by providing e-Surfing Cloud Storage, the cloud storage product run by Shijilong, with "Xunlei Space" services, a public cloud product. The cooperation will enable e-Surfing Cloud Storage to cover both public cloud and private cloud services. As part of the cooperation, the parties intend to launch a joint membership program, under which users will have simultaneous access to both of their cloud storage services. The cooperation represents a first step for the parties to develop collaboration in their product portfolios. And the parties intend to explore other consumer-related products to achieve resource sharing and mutual benefits.
BMRN

Hot Stocks

08:34 EST BioMarin expands clinical program for vosoritide with new studies - BioMarin Pharmaceutical announced that the Company is expanding its clinical program for vosoritide, an investigational analog of C-type Natriuretic Peptide, or CNP, with two new Phase 2 studies. The first study is sponsored by BioMarin to investigate the safety of vosoritide in infants with achondroplasia at risk of life-threatening foramen magnum compression. The second study is an investigator-initiated study sponsored by Children's National Hospital in Washington, D.C. to investigate vosoritide in children with selected genetic forms of short stature, which together represent addressable patient populations of approximately 275,000. BioMarin announced that the Company has enrolled the first child in a Phase 2 randomized, controlled, open-label clinical trial with an open-label extension to investigate the safety of vosoritide in infants with achondroplasia at risk of requiring cervicomedullary decompression surgery to alleviate compression at the foramen magnum, the opening in the base of the skull through which the spinal cord passes. In addition, the study will also measure a secondary endpoint to evaluate the effect of vosoritide on growth of the foramen magnum volume through MRI scans.
FIXX PFE

Hot Stocks

08:34 EST Homology Medicines announces $60M investment from Pfizer - Homology Medicines (FIXX) announced today that Pfizer Inc. (PFE) has agreed to make a $60 million equity investment in Homology. Pfizer has agreed to purchase 5,000,000 of Homology's common stock at a price of $12.00 per share, as part of the Pfizer Breakthrough Growth Initiative, which was announced earlier this year. The purchase by Pfizer is expected to close on or about November 10, 2020. In connection with the investment, Pfizer's Dr. Cheng will join Homology's Scientific Advisory Board to participate in matters related to the development of the Company's PKU product candidates: HMI-102 gene therapy candidate for adults with PKU and HMI-103 gene editing candidate for pediatric patients with PKU. Additionally, the Company has granted Pfizer a right of first refusal on future transactions involving these programs. Homology intends to use the net proceeds of the offering to help fund its ongoing and planned PKU clinical trials, as well as the Company's central nervous system programs. Based on current projections, together with the anticipated proceeds of $60 million from the Pfizer equity investment, Homology expects cash resources to fund operations into the third quarter of 2022.
NUVA

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08:34 EST NuVasive receives FDA 510(k) clearance for thoracolumbar interbody portfolio - NuVasive announced that it has received 510(k) clearance from the U.S. FDA for its thoracolumbar interbody portfolio to include the treatment of multi-level sagittal deformities of the thoracolumbar spine. This clearance expands the portfolio's indications from one- to two-level spine surgery, to now multiple levels, for the treatment of sagittal malalignment.
MCD

Hot Stocks

08:34 EST McDonald's sees more 'starts and stops' with virus resurgences
LEAF

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08:33 EST Leaf Group appoints Rob Krolik, Suzanne Hopgood to board - Leaf Group announced the appointment of Rob Krolik and Suzanne Hopgood to Leaf Group's Board of Directors, effective November 6, 2020. The Company also announced that current Board Member John Pleasants has retired from his position, also effective November 6, 2020. Mr. Krolik joins Leaf Group's Board of Directors with strong corporate governance and financial leadership experience in ecommerce and digital businesses. He currently serves as General Partner and Chief Financial Officer at Burst Capital. Ms. Hopgood is a seasoned board member and executive with a developed perspective on leading global trends in corporate governance. She currently serves as Managing Member of The Hopgood Group, LLC and as Chairman of the Board for the Capital Region Development Authority.
MCD

Hot Stocks

08:33 EST McDonald's 'pleased' with recovery to date - Comments taken from Q3 earnings conference call.
INFI

Hot Stocks

08:33 EST Infinity Pharmaceuticals presents MARIO-1 Phase 1/1b data at SITC - Infinity Pharmaceuticals announced the presentation of data from the melanoma and squamous cell carcinoma of the head and neck cohorts from the MARIO-1 clinical trial at the SITC. MARIO-1 is the Company's ongoing Phase 1/1b evaluating eganelisib as a monotherapy and in combination with Opdivo n patients with solid tumors in collaboration with BMS. The data presented from the melanoma and SCCHN cohorts of MARIO-1, both which were designed to isolate the clinical benefit of eganelisib by examining clinical activity in patients not expected to benefit from checkpoint inhibitors due to progression on a checkpoint inhibitor as the immediate prior therapy, demonstrate that eganelisib was well tolerated and active, and suggest that greater clinical benefit is achieved in patients who received two or fewer prior lines of therapy. "These data from the melanoma and SCCHN cohorts of MARIO-1 provide important validation of our mechanism and overall clinical strategy," said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals. "In addition to establishing a favorable safety profile, we see on-mechanism activity of eganelisib with translational data that show decreased immune suppression as measured by MDSCs as well as increased immune activation during eganelisib treatment. Across these cohorts, we are encouraged by the disease control rate in patients with immediate prior progression on a checkpoint inhibitor, with higher response rates in patients who have received two or fewer prior lines of therapy. These results leave us increasingly confident in our clinical strategy to move eganelisib to earlier treatment settings in our ongoing studies: to the second line in MARIO-275, and to the front-line setting in MARIO-3. Taken together, we are encouraged by these results which suggest eganelisib has the potential to provide meaningful clinical benefits across diverse solid tumors as a first-in-class modulator of immune activity."
CKPT

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08:32 EST Checkpoint Therapeutics presents updated cosibelimab lung cancer results - Checkpoint Therapeutics announced updated interim results from the ongoing global, open-label, multicohort Phase 1 clinical trial of its anti-PD-L1 antibody, cosibelimab, in patients with advanced cancers, including a cohort of patients with previously untreated high PD-L1 expressing advanced non-small cell lung cancer. The updated interim results are being presented in a poster presentation at the Society for Immunotherapy of Cancer 35th Anniversary Annual Meeting being held virtually from November 9-14, 2020. Summary of NSCLC Data Presented at SITC: The ongoing trial is evaluating cosibelimab administered as a fixed dose of 800 mg every two weeks or 1200 mg every three weeks. The NSCLC cohort includes patients with Stage IV NSCLC with high PD-L1 tumor expression as determined by immunohistochemistry, with no prior systemic treatment for advanced/metastatic NSCLC and no epidermal growth factor receptor activating mutation or anaplastic lymphoma kinase translocation. As of the interim analysis, 25 patients with NSCLC were enrolled and evaluable for efficacy by investigator assessment with at least one post-baseline tumor assessment or discontinued treatment prior. At the time of analysis, 123 patients with advanced cancers had been treated with cosibelimab and were evaluable for safety. Cosibelimab appeared to be safe and well-tolerated with a potentially favorable safety profile as compared to anti-PD-1 therapies currently available. The most common treatment-related adverse events included fatigue and rash, with only 2 patients discontinuing treatment due to a TRAE. Grade greater than or equal to3 TRAEs occurred in only 6 patients, most commonly anemia and fatigue.
ALK

Hot Stocks

08:32 EST Alaska Air CEO Brad Tilden to retire, Ben Minicucci to succeed - Alaska Air Group's board of directors announced that Brad Tilden will retire as CEO on March 31, 2021, and Ben Minicucci, president of Alaska Airlines and a member of the Alaska Air Group board, will succeed him. Tilden will continue to serve as Alaska's board chair. During Minicucci's 16-year career with Alaska, he has contributed in various roles of increasing responsibility. In 2016, he became president of Alaska Airlines and he was also named CEO of Virgin America upon Alaska's acquisition of the airline. From 2009-2016, he served as executive vice president and COO.
TSQ

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08:32 EST Townsquare Media says experiencing all time record engagement - Sees 30,000 subscribers in 29 months or less. Says expects to reach $100M in annual net revenue in two to three years. Says company is not limited to being just a radio or audio company. Says advertising segment improved greatly. Says political revenue has been on fire this year. Sees 2020 political revenue $16M. Says not concerned about liquidity. Says not providing formal guidance for Q4. Says goal is to improve Q4 net revenue to down 7.5%. Comments taken from Q3 earnings conference call.
WKHS

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08:32 EST Workhorse Group awarded order for 500 C-1000 delivery vehicles from Pritchard - Workhorse Group announced that it has received a purchase order for 500 of its all-electric C-1000 delivery vehicles from Pritchard Companies. Inventory financing will be provided by Hitachi Capital America as part of the Company's previously announced strategic partnership with HCA. Vehicles will be distributed through Pritchard Companies' dealership locations across the country. Throughout its 107 years of operating history, Pritchard Companies has developed a robust national network of partners and is one of the nation's largest commercial vehicle distributors, selling over 30,000 units annually to customers across all 50 states.
ABC

Hot Stocks

08:30 EST AmerisourceBergen names Dr. Lonie Haynes as Chief Diversity & Inclusion Office - "As part of its commitment to fostering a diverse and inclusive culture, AmerisourceBergen, a global healthcare solutions leader, announced the appointment of Dr. Lonie Haynes as the company's SVP and Chief Diversity & Inclusion Officer. In this new role Dr. Haynes will be responsible for working with leaders across the company to define and execute on a holistic and results-oriented diversity and inclusion strategy that inspires associates across all dimensions of diversity to achieve their full potential and to advance the company's purpose to create healthier futures.
IOVA

Hot Stocks

08:30 EST Iovance Biotherapeutics presents interim data for LN-145 w/ pembrolizumab - Iovance Biotherapeutics presented new interim clinical data for the tumor infiltrating lymphocyte therapy LN-145 in combination with pembrolizumab in advanced, recurrent, or metastatic head and neck squamous cell carcinoma who are immune checkpoint inhibitor naive at the 35th Anniversary Annual Meeting of the Society for Immunotherapy of Cancer. New interim results from the ongoing IOV-COM-202 study of LN-145 in various settings and indications are now available from Cohort 2A in a poster titled, "Safety and efficacy of tumor infiltrating lymphocytes in combination with pembrolizumab for advanced, recurrent or metastatic HNSCC." As of the October 16, 2020 data extract date for the poster, LN-145 in combination with pembrolizumab shows a 44.4% overall response rate. and a disease control rate of 88.9%. Median DOR was not reached at 8.6 months of median study follow up. The HNSCC patients in Cohort 2A were PD-1 blockade naive and 89 percent had progressed on prior chemotherapy. The adverse event profile of the combination therapy was consistent with those of pembrolizumab and TIL therapy, lymphodepletion and IL-2, as well as the underlying disease. HPV status was positive in four patients, negative in three patients and unknown in two patients. CPS scores were greater than or equal to 20 in five patients, below 20 in two patients and missing in two patients. The poster is available in the "Publications and Scientific Presentations" section of the Iovance corporate website.
ENPH

Hot Stocks

08:28 EST Enphase Energy, Cutler Bay Solutions partner to deliver battery storage systems - Enphase Energy announced that Cutler Bay Solar Solutions has deployed more than 1.5 MWh of Enphase Encharge storage systems. Cutler Bay Solar Solutions was a lead installer in the Enphase Encharge storage system field testing program, providing technical and useability feedback directly to Enphase. Since its public release in late July 2020, Cutler Bay Solar Solutions has deployed more than 1.5 MWh of Encharge storage systems across 80 homes in the South Florida market. The installations include a combination of Enphase Encharge 10 and Encharge 3 storage systems, which offer usable and scalable battery storage capacities of approximately 10.1 kWh and 3.4 kWh, respectively. The Encharge storage system is modular, allowing installers the flexibility for either backing up the whole home or starting small and growing over time, depending on homeowner needs.
PTOTF

Hot Stocks

08:27 EST Patriot One appoints Peter Evans as CEO - Patriot One Technologies announced the appointment of Peter Evans as CEO, effective on Monday, November 16, 2020. Mr. Evans succeeds Martin Cronin who will remain on as a director of the Company. Evans brings over 25 years of experience working with venture-backed and public companies in executive leadership, operations and board roles. Peter Evans will join fellow senior executives, Dietmar Wennemer, President and COO, and Karen Hersh, CFO, at the Company's Corporate Headquarters in downtown Toronto, Ontario.
MDGS

Hot Stocks

08:25 EST Medigus to invest additional $150,000 in Polyrizon - Medigus announced the signing of a non-binding term sheet for an investment in Polyrizon Ltd., a private company engaged in developing biological gels for the purpose of protecting patients against biological threats. Medigus currently holds 19.9% in Polyrizon, and following the additional investment of $100,000, Medigus will own approximately 33% of the Company on a fully diluted basis, excluding the shares that may be issued upon the deferred closing, with such holdings subject to adjustment upon the occurrence of a deferred closing. Medigus and other Polyrizon shareholders shall have the option to invest an additional aggregate amount of up to $50,000 for a period of 60 days after the initial closing. Medigus and Polyrizon previously entered into investment and reseller agreements whereby Medigus was granted an exclusive license to resell Polyrizon's products, focusing on a unique Biogel for protection against COVID-19, commencing once the Polyrizon's products will receive U.S. Food and Drug Administration approval.
XCUR

Hot Stocks

08:25 EST Exicure presents clinical data with cavrotolimod at SITC - Exicure announced the presentation of updated Phase 1b data from the ongoing Phase 1b/2 clinical trial evaluating intratumoral cavrotolimod, AST-008, the Company's SNA-enabled TLR9 agonist, in combination with the anti-PD-1 therapies pembrolizumab, KEYTRUDA or cemiplimab (LIBTAYO, in patients with Merkel cell carcinoma, cutaneous squamous cell carcinoma, and other advanced solid tumors . The Phase 1b dose-escalation stage was designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of cavrotolimod alone and in combination with pembrolizumab, and to identify a recommended Phase 2 dose. Cavrotolimod was dosed intratumorally once weekly for 8 weeks and subsequently once every 3 weeks. Following an initial cavrotolimod monotherapy period, pembrolizumab was initiated at week 3 and dosed in combination with cavrotolimod once every 3 weeks. The Phase 1b stage enrolled patients with locally advanced or metastatic melanoma , Merkel cell carcinoma Updated data from the Phase 1b stage demonstrated that the combination of cavrotolimod and pembrolizumab continued to be well tolerated, with a confirmed overall response rate of 21% according to RECIST v1.1 criteria. The combination immunotherapy regimen induced durable and systemic anti-tumor responses in patients with advanced solid tumors who previously progressed on anti-PD-1 therapy. At the time of enrollment in the clinical trial, 85% of patients were experiencing progressive disease despite treatment with PD-1 blockade and 65% of patients had been treated with 2 or more lines of systemic therapy.
AWH

Hot Stocks

08:25 EST Aspira Women's Health appoints Sandra Brooks to board of directors - Aspira Women's Health announced the appointment of Sandra Brooks, MD, MBA to its Board of Directors. The addition of Dr. Brooks brings the Board composition to seven members with the majority now female. Dr. Brooks is Senior Vice President & Chief Medical Officer at Thomas Jefferson University Hospitals, Center City Division, and a Professor in the Department of Obstetrics and Gynecology, Sidney Kimmel Medical College.
ARTH

Hot Stocks

08:23 EST Arch Therapeutics announces presentations on AC5 Advanced Wound System - Arch Therapeutics highlights a series of clinical case reports and animal studies presented in abstract and poster formats at the 2020 Symposium on Advanced Wound Care Fall, which took place from November 4-6, 2020. The conference was hosted online due to the pandemic. AC5 Advanced Wound System recently received marketing authorization by the US Food and Drug Administration and is now commercially available. A comparable product, AC5 Topical Hemostat, recently received a CE mark in Europe. The following clinical case reports, which examine the use of the product in patients by surgeons, were presented: Enabling Aggressive Surgical Debridement and Healing in a 10-year-old Decubitus Ulcer with a Novel Self-Assembling Peptide-based Advanced Wound Dressing: Concomitant use of debridement and the novel self-assembling peptide-based AC5 Advanced Wound System, which formed a clear conforming dressing over the wound surface, allowed for a more aggressive procedure with bleeding control in a low acuity clinic setting and without the need for thrombin or sutures. In addition, the nanofiber network appeared to cohesively seal the wound bed surface after debridement made the wound devoid of biofilm and senescent host cells. The resulting scaffold allowed for the adhesion, migration, and proliferation of healthy host cells and favorable wound healing outcomes. Healing of a Chronic Refractory Burn Wound with a Novel Self-Assembling Peptide-based Advanced Wound Dressing: The aggressive debridement made possible by the application of AC5 Advanced Wound System, the novel self-assembling peptide-based advanced dressing, facilitated the removal of the infected granulation tissue. This reduction in the wound bioburden likely helped address one of the major stimuli contributing to the chronicity and severity of these types of wounds. Subsequently, the advanced wound dressing appears to have not only enabled accelerated healing of this stalled refractory burn wound, but it also provided a marked improvement in the patient's quality-of-life. Healing of a Complex Surgical Wound using a Novel Self-Assembling Peptide-based Advanced Wound Dressing: AC5 Advanced Wound System, a novel self-assembling peptide-based advanced wound dressing, quickly restarted the previously stalled healing process in this complex surgical wound. The results indicate that the use of this dressing may obviate the need for continued costly treatments and procedures, thus reducing the total cost of lower extremity wound care, while improving patient's quality of life. The following animal studies were presented: Effects of a Self-Assembling Peptide on Second Degree Burn Progression and Healing in a Porcine Model: Conclusion: Overall, SAPH1 treated wounds showed a reduction in thermal damage, as well an increase in the re-epithelialization rate. Interestingly, a lower total bacterial count was also seen with SAPH treatment. These preliminary results suggest that SAPH may have healing benefits when treating second degree burn wounds, however additional studies are needed to substantiate these findings. Effects of a Self-Assembling Peptide on Full-Thickness Wound Healing in a Porcine Model: Conclusion: SAPH exhibited an increase in epithelialization and granulation tissue formation on day 8 as compared to all other treatment groups. SAPH was the only treatment application reaching full re-epithelialization by day 11. Wounds treated with Skin Substitute had lower granulation tissue formation on day 6 as compared to the other treatment groups. SAPH appears to be a promising easy to apply treatment for enhancing wound healing; additional studies are needed to validate these findings.
LEGN

Hot Stocks

08:23 EST Legend Biotech appoints Ye Wang as chairwoman, Ying Huang as CEO - Legend Biotech announced that Ye Wang was appointed chairwoman of the board of Legend Biotech. The board of directors also named Ying Huang as CEO of Legend Biotech, effective immediately. Huang had been serving as interim CEO since September 21, 2020. Huang will continue to hold his position of CFO until such time as a successor CFO is identified. Both appointments were made with the unanimous approval of the board, including by means of a written proxy of Fangliang Zhang. In a written statement, Zhang, who remains a member of the board, expressed his support for Huang's assumption of the CEO role on a non-interim basis, and noted that the transition further enhances the operational execution of Legend Biotech. Wang has served as a member of Legend Biotech's board since May 2015. Wang has been the COO of GenScript Biotech, Legend Biotech's parent majority shareholder, since 2014, has served on GenScript's board of directors since 2009 and has served as GenScript's president since December 2017, responsible for GenScript's strategies and overall operational management. Since joining Legend Biotech in July 2019, Huang played a role during the company's crossover round financing and IPO, which was among the largest biotech IPOs of 2020. In addition to his responsibility for Legend Biotech's financial function, he is a member of the Legend team that manages the company's collaborative efforts. Huang brings more than nine years of experience in research and development and 12 years of experience as a biotechnology analyst on Wall Street. Prior to joining Legend Biotech, Huang was managing director and head of biotech equity research at Bank of America Merrill Lynch.
GILT

Hot Stocks

08:22 EST Gilat Satellite, SES expand partnership with follow-on order - Gilat Satellite Networks announces that SES and Gilat are expanding their partnership with a multi-million-dollar follow-on order for high-speed modems. Gilat's modems will deliver multi Gbps throughput, targeting high-end services over SES's O3b and O3b mPOWER MEO constellations. Gilat's high-throughput modems will support SES in delivering fiber-equivalent services for government and high-end enterprise solutions.
OM

Hot Stocks

08:21 EST Outset Medical appoints Steve Williamson as Chief Commercial Officer - Outset Medica announced the appointment of Steve Williamson as Chief Commercial Officer. In this role, Mr. Williamson will lead Outset's commercial and service organizations as adoption of the Tablo Hemodialysis System continues to spread rapidly across the full spectrum of dialysis care, from hospitals to home. "This year we have driven meaningful penetration within top regional and national health systems, and received FDA clearance for home," said Leslie Trigg, President and Chief Executive Officer. "As we rapidly scale our organization to meet demand, Steve's customer-centric, agile approach, combined with his ability to build high performance teams and culture will help fuel Outset for long-term growth."
ONCY

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08:21 EST Oncolytics and SOLTI present clinical data from AWARE-1 study - Oncolytics Biotech and SOLTI-Innovative Breast Cancer Research announced the publication of an electronic poster with clinical data from the AWARE-1 window-of-opportunity breast cancer study at The Society for Immunotherapy of Cancer 35th Anniversary Annual Meeting. The AWARE-1 study, a collaboration between Oncolytics Biotech and SOLTI, combines the appropriate intervention for each patient's breast cancer sub-type, plus pelareorep, with or without atezolizumab, followed by surgery in early-stage breast cancer patients. Data presented in the electronic poster were from the ten HR+/HER2- breast cancer patients that make up the study's first cohort. These data demonstrate the ability of pelareorep to promote a pro-inflammatory tumor microenvironment and provide a basis for the findings of a prior successful phase 2 trial that showed a near doubling of overall survival with pelareorep treatment in HR+/HER2- breast cancer patient.
CNSP

Hot Stocks

08:20 EST CNS Pharmaceuticals: Berubicin Phase 2 trial design to be submitted to FDA - The company plans to submit an Investigational New Drug application to the U.S. FDA, which includes a novel clinical trial designed to build on the encouraging results observed in a prior Phase 1. The Phase 2 trial will randomize patients to Berubicin or standard of care. This upcoming trial will include interim assessments that will evaluate the comparative safety and effectiveness of these treatments with an adaptive design intended to complete a thorough investigation into Berubicin as expeditiously as possible.
IMAB

Hot Stocks

08:19 EST I-MAB presents results from phase 1 clinical trial evaluating lemzoparlimab - I-Mab announced initial results from its U.S. phase 1 clinical trial, or NCT03934814, evaluating lemzoparlimab for the treatment of relapsed or refractory solid tumors and lymphoma. The results were released in a poster entitled "A first-in-patient study of lemzoparlimab, a differentiated anti-CD47 antibody, in subjects with relapsed/refractory malignancy: initial monotherapy results" at the 2020 Society for Immunotherapy of Cancer, or SITC, Annual Meeting, on November 9. Lemzoparlimab is a unique CD47 antibody that exerts strong anti-tumor activity while exhibiting a minimal binding to red blood cells. It is designed to avoid severe anemia -- a common toxicity of CD47 antibodies of the same class.
CBRL

Hot Stocks

08:18 EST ISS urges addition of 'relevant restaurant expertise' to Cracker Barrel board - Biglari Capital, one of the largest and longest-standing shareholders of Cracker Barrel Old Country Store, beneficially owning approximately 8.7% of the company's outstanding common stock, announced that Institutional Shareholder Services has recognized the need for change on the Cracker Barrel board of directors, calling for the addition of relevant industry experience to the Board. Biglari Capital urges shareholders to support much needed change on the board by voting the GOLD proxy card.
SYK BMY

Hot Stocks

08:18 EST Stryker appoints Giovanni Caforio to board of directors - Stryker (SYK) announced that Giovanni Caforio, M.D., Chairman and CEO of Bristol Myers Squibb (BMY), has been elected to its Board of Directors, effective December 1, 2020.
XNCR

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08:17 EST Xencor presents updated data from the DUET-2 Phase 1 - Xencor reported data from its ongoing Phase 1 study evaluating XmAb 20717, a PD-1 x CTLA-4 bispecific antibody and Xencor's first tumor microenvironment activator, in patients with advanced solid tumors, DUET-2. The preliminary results from the study's expansion cohorts will be presented in a poster titled, "Preliminary safety, pharmacokinetics/pharmacodynamics, and antitumor activity of XmAb20717, a PD-1 x CTLA-4 bispecific antibody, in patients with advanced solid tumors" at the 35th Annual Meeting of the Society for Immunotherapy of Cancer, SITC, by Elaine Shum, M.D., Assistant Professor in the Division of Medical Oncology and Hematology at the NYU Perlmutter Cancer Center. "We are observing activity across multiple tumor types in patients who have already been treated with a checkpoint inhibitor, a difficult-to-treat patient population," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "XmAb20717 continues to be tolerable throughout our expansion cohorts, and importantly in our study we are observing lower rates of some types of immunotherapy-related adverse events, including colitis, than are typically seen with CTLA-4 blockade." "Though data are early, we are especially encouraged by initial activity in patients with metastatic castration-resistant prostate cancer. In the first half of 2021, we plan to initiate a Phase 1b study of XmAb20717 for patients with certain molecular subtypes of mCRPC, as a monotherapy or in combination depending on the subtype, as these patients represent a high unmet medical need," said Allen Yang, M.D., Ph.D., senior vice president and chief medical officer at Xencor. "We are also planning additional cohorts in selected populations within DUET-2, based on clinical activity and unmet medical need. Data are also still maturing in cohorts of patients with renal cell carcinoma, and those with cancers without approved checkpoint therapies, including prostate cancer. We will provide further updates in the coming months."
SAVA

Hot Stocks

08:17 EST Cassava Sciences sees 2020 net cash use $5M
LPTX

Hot Stocks

08:17 EST Leap presents data from Phase 1b/2a clinical trial of DKN-01 - Leap Therapeutics announced the presentation of clinical data from its Phase 1b/2a clinical trial of DKN-01 in patients with advanced esophagogastric cancer, or EGC, at the Society for Immunotherapy of Cancer's 35th Anniversary Annual Meeting. DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1, or DKK1, protein. In the study, high levels of tumoral DKK1 expression correlated with improved clinical outcomes in heterogeneous EGC patients treated with DKN-01 as monotherapy or in combination with pembrolizumab or paclitaxel. Pooled data for the 69 patients in the study for whom tumoral DKK1 expression data is available demonstrated that DKK1-high patients experienced higher overall response rates, a doubling of median progression-free survival, and longer median overall survival as compared to DKK1-low patients.
LQDA

Hot Stocks

08:16 EST Liquidia sees cash sufficient to fund plan into 2022 - As of September 30, 2020, cash totaled $79.6 million. On July 2, 2020, the Company completed an underwritten public offering of 9.375 million shares at a price of $8.00 per share, resulting in gross proceeds of $75.0 million and net proceeds of approximately $70.3 million. The company has begun to implement a more cost-efficient operating plan and estimates that its cash will be sufficient to fund its operating plan into 2022. In addition, a successful close of the RareGen acquisition has the potential to improve the Companys cash runway going forward.
BIOC

Hot Stocks

08:15 EST Biocept awarded patent in Hong Kong for tumor cell detection method - Biocept announces that it has been awarded Hong Kong Patent No. 1188285 entitled, METHODS AND REAGENTS FOR SIGNAL AMPLIFICATION. This patent covers methods for enhancing the detection of cells using fluorescent complexes, including circulating tumor cells, or CTCs. The method covered by this patent expands Biocept's patent protection for sensitive detection of cancer cells. This technology combines seamlessly with Biocept's core technologies using antibodies for CTC enrichment, as well as Biocept's microchannel intellectual property for the capture, enrichment, and imaging of CTCs from patients with cancer collected in Biocept's patented blood transport tube. This could also be important in future applications such as with Single Cell Analysis.
PSMT

Hot Stocks

08:14 EST PriceSmart reports October net merchandise sales up 10.4% to $280.3M - PriceSmart announced that for the month of October, net merchandise sales increased 10.4% to $280.3M from $254M in October a year earlier. Foreign currency exchange fluctuations impacted net merchandise sales negatively by 3.6%, or $9.1M, versus the same one-month period in the prior year. There were 46 warehouse clubs in operation at the end of October and 43 warehouse clubs in operation at the end of October 2019. For the four weeks ended October 25, comparable net merchandise sales for the 43 warehouse clubs open at least 13 1/2 full months increased 4.1% when compared to the same period last year. Foreign currency exchange rate fluctuations impacted comparable net merchandise sales negatively by 3.5%, or $8M, versus the same period in the prior year.
RUBY

Hot Stocks

08:14 EST Rubius Therapeutics sees cash runway into 2022 - As of September 30, 2020, cash, cash equivalents and investments were $207.9 million as compared to $283.3 million as of December 31, 2019, providing Rubius with a cash runway into 2022. During 2020, the Company used $97.1 million of cash to fund operations and $4.5 million to fund capital expenditures, consisting mostly of payments for assets purchased in 2019. In addition, during 2020 the Company drew down the third and final tranche of $25.0 million pursuant to its $75.0 million loan agreement with Solar Capital.
XNCR

Hot Stocks

08:14 EST Xencor annouces new data from preclinical XmAb antibody programs SITC - Xenco announced the presentation of new data from multiple preclinical XmAb bispecific antibody programs and its preclinical IL-12-Fc cytokine program at the 35th Annual Meeting of the Society for Immunotherapy of Cancer ,SITC. "Our XmAb bispecific Fc domains were specifically created to enable the rapid design and simplified development of a wide range of multi-specific antibodies and other protein structures, such as our engineered cytokines," said John Desjarlais, Ph.D., senior vice president and chief scientific officer at Xencor. "At SITC, we are presenting new data from multiple preclinical programs, including CD28 bispecific antibodies, our second class of T cell engagers, that we have designed to conditionally co-stimulate T cells when they are bound to tumor cells. For the first time, we also show data from two selective TGFbeta inhibitors engineered with XmAb bispecific Fc domains."
GLMD

Hot Stocks

08:13 EST Galmed and MyBiotics sign research and development collaboration agreement - Galmed Pharmaceuticals and MyBiotics Pharma announced they have entered into a research and development collaboration agreement to identify and optimize the selected microbiome repertoire associated with the response to Aramchol. The research will also focus on development of a standalone microbiome-based treatment for non alcoholic steatohepatitis, or NASH, and fibrosis.Under the collaboration, MyBiotics will employ its proprietary SuperDonor technology in combination with its MyLiveIn computational AI and screening platforms to identify and optimize consortia of bacteria to reconstitute a NASH patient's gut flora in order to enhance Aramchol's clinical efficacy and response rate. The collaboration also aims to identify specific microbial biomarkers for Aramchol based on macrobiome data collected from Galmed's clinical studies that could serve as a biomarker for Aramchol at early stage of treatment.
ASPU

Hot Stocks

08:13 EST Aspen Group reports 2,659 enrollments in Q2 - Aspen Group announced a quarterly record of 2,659 new student enrollments in the fiscal 2021 second quarter ended October 31, 2020, an increase of 20% year-over-year. Quarterly bookings increased by $10.8 million or 34% year-over-year from $31.3 million to $42.1 million. Aspen Group's business model is evolving to increased contribution from students enrolling in higher LTV nursing licensure degree programs, a primary dynamic affecting the growth in revenue and bookings for the past two years. Aspen University generated a record 2,010 new student enrollments in the second quarter of fiscal year 2021, up 13% sequentially and 10% over the prior year period. The strong enrollment growth at Aspen University was a result of record quarterly enrollments in its Doctoral and BSN Pre-Licensure units. United States University also delivered record enrollments in the second quarter with 649 new student enrollments driven primarily by MSN-Family Nurse Practitioner enrollments, a 65% increase year-over-year.
MPAA

Hot Stocks

08:12 EST Motorcar Parts resumes stock buyback program - "As I stated in our 2020 fiscal year-end release, our industry is resilient, and we are continuing to execute our strategic plans for growth and profitability. We are guardedly optimistic about the near- and long-term opportunities as an essential supplier in the $125 billion hard parts industry and look forward to a recovery from this global crisis. In fact, we are resuming our stock buy-back program subject to market conditions, with current availability of $21.3 million under our existing authorization," management said.
AMGN

Hot Stocks

08:11 EST Amgen announces first presentation of AMG 757 Phase 1 data - Amgen announced the first presentation of AMG 757 Phase 1 clinical safety and efficacy data in relapsed or refractory small cell lung cancer, or SCLC. AMG 757 is an investigational half-life extended bispecific T cell engager molecule targeting delta-like ligand 3, or DLL3. The DLL3 protein is overexpressed on the cell surface of SCLC tumors and minimally expressed in normal tissues.1 Data will be featured during a live oral presentation on Nov. 12 at the Society for Immunotherapy of Cancer's 35th Annual Meeting being held virtually. "These AMG 757 proof of concept data in small cell lung cancer and the recently presented AMG 160 data in prostate cancer provide encouraging evidence of the BiTE platform's clinical activity in solid tumors," said David M. Reese, executive vice president of Research and Development at Amgen. This interim analysis of the Phase 1 dose escalation study evaluated 40 patients with relapsed/refractory SCLC at a dose of up to 10 mg every two weeks. In this study, AMG 757 demonstrated an acceptable safety profile and showed preliminary evidence of anti-tumor activity.
MYGN

Hot Stocks

08:10 EST Myriad pursuing strategic alternatives for Myriad RBM, Dermatology units - Announced the decision to pursue strategic alternatives for the Myriad RBM and Dermatology business units as part of the company's transformation and growth plan.
URGN

Hot Stocks

08:07 EST UroGen Pharma sees FY20 total operating expense $138M-$143M - The Company provided an update to previously issued guidance for 2020. UroGen now expects 2020 total operating expense in the range of $138 to $143 million, including non-cash share-based compensation expense of $25 to $29 million, subject to market conditions. Other non-operating income for 2020 is anticipated to be approximately $2.0 million.
GSK PFE

Hot Stocks

08:06 EST GSK's ViiV says injectable cabotegravir superior to oral SOC for HIV prevention - ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer (PFE) and Shionogi Limited as shareholders, announced that an independent data safety monitoring board recommended the early unblinding of the HIV Prevention Trials Network 084 study evaluating the safety and efficacy of investigational, long-acting, injectable cabotegravir for HIV prevention in women. Following a pre-specified interim analysis, the DSMB indicated that cabotegravir met the primary objective of demonstrating superiority when compared to the current standard of care for women, daily oral emtricitabine/tenofovir disoproxil fumarate 200 mg and 300 mg tablets. The study showed cabotegravir was 89% more effective than daily oral FTC/TDF for pre-exposure prophylaxis. The early study unblinding for superior efficacy in this prevention trial in women follows results reported earlier this year from a companion study that also established long-acting cabotegravir's superiority to daily oral PrEP in preventing HIV among men who have sex with men and transgender women who have sex with men. The HPTN 084 study, with 3,223 participants in 20 sites across seven countries in sub-Saharan Africa, is the first study of long-acting injectable therapy for HIV prevention among women. The data showed that there was a statistically significant advantage for the women who received cabotegravir compared with the women who received FTC/TDF. While both were highly effective at preventing HIV in the study population, cabotegravir was superior.
ALNA

Hot Stocks

08:06 EST Allena Pharmaceuticals CFO Edward Wholihan to step down - Allena Pharmaceuticals also announced the resignation of Edward Wholihan, Chief Financial Officer, who will be stepping down for personal reasons. Mr. Wholihan will continue to serve in his current role as the Company conducts a search for his successor.
MGTA KNSA

Hot Stocks

08:06 EST Magenta Therapeutics appoints Steve Mahoney as CFO, COO - Magenta Therapeutics (MGTA) announced the appointment of Steve Mahoney as CFO and COO. As chief financial and operating officer, Mahoney will serve as a member of the company's executive team and will oversee all aspects of financial planning and analysis, as well as investor community engagement, including investor relations and other external stakeholder communications, in addition to R&D capital allocation strategy and operations and facilities management. Mahoney comes to Magenta with more than 20 years of global biotechnology sector industry experience. Most recently, Mahoney served as president and COO of Kiniksa (KNSA), where the company raised capital in three private financing rounds, an initial public offering and a follow-on financing.
ALNA

Hot Stocks

08:04 EST Allena expects cash, cash equivalents to fund requirement into 4Q21 - Based on its current plans, Allena expects that its existing cash and cash equivalents, together with the funds available under its agreement with Pontifax, will be sufficient to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2021.
NAV VWAGY

Hot Stocks

08:04 EST Traton reaches agreement for acquisition of Navistar at $44.50/share in cash - Volkswagen's (VWAGY) TRATON and Navistar International Corporation (NAV) announced that they have entered into a definitive merger agreement pursuant to which TRATON will become the owner of all of the outstanding common shares of Navistar not already owned by TRATON at a price of $44.50 per share in cash. TRATON currently owns 16.7% of the outstanding shares of common stock of Navistar. The sources of funding for the cash acquisition of the outstanding Navistar shares not already owned by TRATON includes fully committed financing by Volkswagen Group for the equity purchase price of about $3.7B. TRATON remains committed to maintaining an investment grade rating. The transaction is targeted to close in mid 2021, and is subject to Navistar shareholder approval, customary closing conditions as well as regulatory approvals. Major shareholders Icahn Capital LP and MHR Fund Management LLC have agreed to vote their shares in favor of the transaction.
BTU

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08:03 EST Peabody Energy sees Q4 PRB sales 23M tons - Based on current estimates, Q4 seaborne volumes are expected to improve modestly, while U.S. thermal volumes are expected to decline slightly compared to the third quarter. Seaborne met costs are anticipated to rise primarily due to a planned longwall move at Metropolitan and changes in product mix, while seaborne thermal costs are expected to be largely in line with the third quarter. Current Q4 priced and committed sales are as follows: 23M tons of PRB sales at an average realized price of $11.28 per ton; 5M tons of other U.S. thermal sales at an average realized price of $36 per ton; 2M tons of seaborne thermal export sales at an average realized price of $47 per short ton; 700,000 tons of seaborne met sales at an average realized price of $88 per short ton. In addition, 2020 full year capital expenditures and SG&A have been reduced to approximately $185M and $105M, respectively. Current 2021 market expectations reflect improvement in seaborne coal demand as economies continue to recover from COVID-19. In addition, modestly higher forward natural gas prices are expected to offset the impact of additional retirements within the U.S. thermal market. Other factors that will determine Peabody's 2021 sales volume include the anticipated resumption of production at Shoal Creek in early 2021 as well as lower production due to the United Wambo joint venture transition.
NLTX

Hot Stocks

08:02 EST Neoleukin Therapeutics sees cash sufficient into 2023 - Based upon its current operating plan, Neoleukin believes that its cash-on-hand will be sufficient to fund operations into 2023.
MGDPF

Hot Stocks

07:58 EST Marathon Gold reports additional drill results from Valentine Gold Project - Marathon Gold is pleased to report additional drill results from recent exploration drilling at the Valentine Gold Project, central Newfoundland. These latest results represent fire assay data from fifteen step-out drill holes over an 850 metre strike length of the Sprite Corridor extending from the Berry Zone northeastward towards the Frozen Ear Pond Road. Highlights include: VL-20-876 intersected 4.91 g/t Au over 22 metres, including 20.10 g/t Au over 1 metre and 11.97 g/t Au over 1 metre and 53.44 g/t Au over 1 metre; VL-20-851 intersected 5.79 g/t Au over 5 metres including 20.41 g/t Au over 1 metre; VL-20-855 intersected 23.17 g/t Au over 2 metres; VL-20-879 intersected 15.52 g/t Au over 1 metre and 19.16 g/t Au over 1 metre; All quoted intersections comprise uncut gold assays in core lengths. Gold mineralization at the Valentine Gold Project is contained predominantly within shallowly southwest dipping, en-echelon stacked Quartz-Tourmaline-Pyrite-Gold veins. At the Leprechaun and Marathon Deposits, as well as at the new Berry Zone, these QTP-Au veins form densely stacked and northwest plunging "Main Zone" envelopes within intrusive host rocks on the hanging wall side of the Valentine Lake Shear Zone. The extent of mineralization appears related to the size and frequency of sheared mafic dykes which extend northeast-southwest within the hanging wall, parallel to the shear zone. Exploration drilling is generally undertaken in two orientations: down steeply towards the northwest at a high angle to the individual veins and down-plunge of the Main Zone stacking, or obliquely towards the southeast sub-parallel to the individual veins and across the strike of Main Zone mineralization. The results released today are derived from fifteen drillholes extending over an approximately 750 metre strike extent between sections 14070E and 14760E northeast of the Berry Zone. Eight holes were oriented steeply down to the northwest testing for "Main Zone" type stacked QTP-Au mineralization and seven holes were oriented to the southeast drilling from the hanging wall towards the footwall contact. Overall, fourteen of the fifteen drill holes returned "significant" drill intersections of greater than 0.7 g/t Au. Each of these fourteen holes returned additional intersections with gold grades above the 0.3 g/t Au cut-off used in the January 2020 Mineral Resource Estimate for the Project. No economic mineralization was encountered in drill hole VL-20-872. As part of the Valentine Gold Project 2020 exploration program, 10,977 metres of reconnaissance drilling was completed in two areas located south of the Valentine Lake Shear Zone. This has been the first drilling program at the Project focused on systematically testing the potential for sedimentary-hosted mineralization in the footwall rocks of the Valentine Lake Shear Zone. These footwall areas also represent the proposed site of mine infrastructure elements such as the tailings management facility, plant site and Leprechaun waste rock facility. An additional 2,937 metres of dedicated condemnation drilling was completed to the north of the Marathon Deposit in an area designated for the Marathon waste rock facility. These drill programs identified several isolated areas of QTP-Au mineralization. Follow up work is planned for 2021, including trenching and prospecting. However, at this time, these results are not considered to be indicative of an economic deposit, allowing each area to be considered for infrastructure placement in the ongoing Feasibility Study.
USEG

Hot Stocks

07:55 EST U.S. Energy to acquire East Texas assets in all-stock transaction - U.S. Energy announced that the Company has entered into a Purchase and Sale Agreement to acquire operated producing assets located in Liberty County, Texas in an all-stock transaction. Acquisition Highlights: Proved Developed Reserves estimated at approximately 242,300 barrels of oil. PV-10 estimated at $1.2 million at current strip pricing. 680 net acres in Liberty County, Texas all held by production. Properties average a 100% working interest and 86% net revenue interest. Purchase price $250,000 in U.S. Energy restricted common stock. As of October 1, 2020, the Properties had total estimated Proved Developed Reserves of approximately 242,300 barrels of oil, comprised entirely of Proved Developed Producing and Proved Developed Non-Producing reserves, and had a present value of estimated future net revenues before income taxes discounted at 10% value of approximately $1.2 million. The Properties are operated with a 100% working interest and 86% net revenue interest. The Properties also contain 680 net acres which are 100% held by production. All assets are located in Liberty County, Texas. The consideration payable for the assets is expected to be $250,000 in U.S. Energy restricted common stock. The Transaction is expected to close in the fourth quarter of 2020, subject to the satisfaction of customary closing conditions.
REKR

Hot Stocks

07:53 EST Oklahoma selects Rekor Systems to mitigate uninsured motorists - Rekor Systems announced that the State of Oklahoma will integrate the Company's Rekor One platform across the state to provide vehicle information associated with uninsured motorists as part of the state's Uninsured Vehicle Enforcement Diversion Program, which is operated by the Oklahoma District Attorneys Council.
NTLA

Hot Stocks

07:53 EST Intellia Therapeutics doses first patient in trial of NTLA-2001 - Intellia Therapeutics announced that the first patient has been treated with NTLA-2001, which the company is developing as a single-course, potentially curative therapy for transthyretin amyloidosis. Intellia's global Phase 1 study is to evaluate NTLA-2001 for hereditary ATTR with polyneuropathy. Following safety assessment and dose optimization, Intellia intends to further evaluate NTLA-2001 in a broader ATTR patient population of both polyneuropathy and cardiomyopathy patients.
CVE

Hot Stocks

07:52 EST Cenovus to sell Marten Hills oil assets for approx. $100M - Cenovus Energy through a wholly owned partnership, has entered into a definitive agreement to sell its Marten Hills oil assets in northern Alberta to Headwater Exploration Inc. for initial cash and common share equity consideration of approximately $100 million. Total consideration paid to Cenovus consists of $35 million in cash and 50 million common shares of Headwater, plus 15 million share purchase warrants. Each warrant will entitle the holder to acquire one Headwater common share for a period of three years following the completion of the transaction at an exercise price of $2 per share. Upon closing, Kam Sandhar, Senior Vice-President, Conventional and Sarah Walters, Senior Vice-President, Corporate Services will represent Cenovus on the Board of Directors of Headwater. In addition to the initial consideration, Headwater has agreed to a Gross Overriding Royalty agreement that gives Cenovus the opportunity to benefit from future development of the Clearwater formation at Marten Hills. Headwater has committed to spending at least $100 million on the acquired lands by the end of 2022. The sale is expected to close on or about December 22, 2020, subject to customary closing conditions. From its initial investment at Marten Hills, Cenovus always kept open the option to either continue developing or divest the asset. Cenovus determined this divestiture was a unique opportunity to accelerate value generated from the Marten Hills assets, particularly in the context of the deferral of exploration and development spending as part of the company's response to lower oil prices resulting from the COVID-19 pandemic.
KTOV BMY

Hot Stocks

07:50 EST Kitov expands planned Phase 1/2 clinical trial of CM24 - Kitov Pharma (KTOV) announced that the company and Bristol Myers Squibb (BMY) have amended their Clinical Trial Collaboration and Supply Agreement to reflect the expansion of the planned Phase 1/2 clinical trial evaluating CM24 in advanced non-small cell lung cancer with a new cohort to also evaluate CM24 in patients with pancreatic cancer. The Phase 1/2 clinical trial will evaluate CM24, a monoclonal antibody targeting CEACAM1, in combination with nivolumab in patients with advanced non-small cell lung cancer. With this expansion, the trial is now also planned to evaluate CM24 in combination with nivolumab in addition to nab-paclitaxel in patients with pancreatic cancer. In an initial Phase 1 study consisting of a monotherapy dose escalating IV administration of CM24 administered every two weeks, in 27 patients with advanced malignancies, CM24 was found to be safe and well-tolerated in all patients, with no discontinuations of study drug or dose limiting toxicities. In the efficacy evaluable patients, subjects were highly refractory to therapy, having received between two and eight prior therapied. Eight of the evaluable patients achieved stable disease, with most of these patients responding at the higher dose levels of 3mg/kg and 10mg/kg. Pharmacokinetic analysis revealed non-linearity, and modeling suggested that a higher dose level is required to achieve full saturation of CEACAM1 receptors. The Phase 1/2 clinical study will encompass a dose escalation of CM24 from 10mg/kg to 20mg/kg with nivolumab for the treatment of refractory cancer patients with NSCLC, pancreatic cancer, ovarian carcinoma, melanoma or thyroid carcinoma, in order to determine a recommended Phase 2 dose. Subsequently, two expansion arms will be opened: the first in patients with NSCLC who have become refractory to first-line immunotherapy, and will receive CM24 in combination with nivolumab, and the second in metastatic pancreatic adenocarcinoma patients who have progressed after first-line chemotherapy treatment, and will receive CM24 in combination with nab-paclitaxel and nivolumab. Study endpoints will include both safety and preliminary efficacy in these refractory patients.
PASG NVTA

Hot Stocks

07:41 EST Passage Bio, Invitae collaborate to facilitate genetic testing - Passage Bio (PASG) and Invitae (NVTA) announce a collaboration to facilitate genetic testing and support early identification of GM1 gangliosidosis through Invitae's Detect Lysosomal Storage Disorders. The two companies also are partnering to provide educational clinical trial information to clinicians and patients. The Detect LSDs program offers genetic testing and genetic counseling at no charge to patients to encourage earlier diagnosis of lysosomal storage disorders like GM1 and, as a result, earlier access to clinical trials. In addition, Invitae provides clinical trial information and education to clinicians and patients who may benefit. Currently, the Detect LSDs program is available to patients within the United States and Canada.
CMPS

Hot Stocks

07:40 EST Compass Pathways joins the Psychiatry Consortium - COMPASS Pathways has joined the Psychiatry Consortium, an international collaboration to accelerate drug discovery and development in areas of urgent, unmet medical need. The Psychiatry Consortium, managed by Medicines Discovery Catapult, is a strategic collaboration of leading medical research charities and pharmaceutical companies focusing on the challenge of identifying and validating novel drug targets to address the unmet therapeutic needs of people living with mental health conditions. COMPASS Pathways will work alongside Psychiatry Consortium members and academic partners to advance research projects, providing support through access to funding, expertise, and commercialisation know-how. The Psychiatry Consortium seeks project proposals from the global psychiatric research community via biannual open calls for applications - the next call for applications will open in January 2021.
INMB

Hot Stocks

07:39 EST INmune Bio doses first patient in Phase 2 trial of Quellor - INmune Bio announced that the first patient has been dosed in its Phase 2 clinical trial evaluating Quellor for the treatment of pulmonary complications from COVID-19. Quellor is a selective soluble Tumor Necrosis Factor inhibitor designed to potentially prevent the progression of immune mediated pulmonary complications resulting from SARS-CoV-2 viral infection. The dosing of the first patient took place at UofL Health - Jewish Hospital, Louisville, KY. As the largest academic health system in Kentucky, UofL Health is committed to increasing regional access to leading edge treatments and therapies. The double-blind, randomized, placebo-controlled Phase 2 clinical trial will enroll 366 COVID-19 high risk patients in two equal sized cohorts: standard of care, which may include remdesivir, and SOC plus Quellor given as a 1mg/kg subcutaneous injection on admission to the hospital. A second dose of Quellor may be given a week later if the patient remains hospitalized. High risk patients include the elderly, patients with diabetes, cardiovascular disease, obesity, African American or Hispanic ethnicity. The primary study endpoint is the need for mechanical ventilation during the 28 days following admission to the hospital, including CPAP, BiPAP or intubation. Secondary endpoints include transfer to the ICU, new onset neurologic, cardiovascular or thromboembolic disease, development of renal failure or death. The first 100 patients randomized into the study will provide proof-of-concept and inform a "go/no go" decision by the Data Safety Monitoring Board. If the DSMB recommends that the trial continue, the remaining 266 patients will be enrolled.
AZN

Hot Stocks

07:39 EST AstraZeneca says Calquence approved in EU for treatment of CLL - AstraZeneca's Calquencehas been approved in the European Union for the treatment of adult patients with chronic lymphocytic leukaemia, or CLL, the most common type of leukaemia in adults, the company announced. Calquence is approved for the treatment of CLL and small lymphocytic lymphoma in the U.S. and is approved for CLL in several other countries worldwide. Calquence is also approved for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy in the U.S. and several other countries. Calquence is not currently approved for the treatment of MCL in Europe, the company said.
CBRL

Hot Stocks

07:38 EST Cracker Barrel announced that the ISS recommends shareholders to vote WHITE - Cracker Barrel Old Country Store announced that Institutional Shareholder Services, or ISS, a leading independent proxy advisory firm, has recommended that Cracker Barrel shareholders vote on the Company's WHITE proxy card at the Annual Meeting of Shareholders on November 19. ISS determined that there was no need for change on the Cracker Barrel Board at this juncture, and recommended that shareholders not support Sardar Biglari's nominee, Raymond Barbrick.
CTRA

Hot Stocks

07:36 EST Contura Energy sees FY21 SG&A $45M-$50M - The company is introducing 2021 guidance with coal shipments guidance range of 20.4M tons - 22.2M tons, with CAPP - Met segment volume expected to be between 13.5M-14.5M tons with pure metallurgical coal shipments of 12.5M-13.0M tons and thermal shipments in this segment of 1.0M-1.5M tons. CAPP - Thermal segment volume is anticipated to be between 1.3M tons -1.7M tons. NAPP volumes are expected to be in the range of 5.6M tons-6.0M tons. For 2021, Contura has committed and priced approximately 34% of its metallurgical coal within the CAPP - Met segment at an average price of $86.41 per ton and 72% of thermal coal in the CAPP - Met segment at an average expected price of $52.11 per ton. In the CAPP - Thermal segment the company is 99% committed and priced at an average price of $57.17 per ton and 100% committed and priced for NAPP at an average price of $40.43 per ton. The company expects a strong cost performance to continue in 2021 with CAPP - Met cost of coal sales per ton anticipated at a range of $68.00 to $74.00. CAPP - Thermal is expected to be in the range of $45.00-$49.00 per ton and NAPP between $33.00-$37.00 per ton. Sees FY21 SG&A $45M-$50M, excluding non-recurring items and stock compensation. In light of our decision to forgo certain capital expenditures for NAPP, our overall 2021 capital expenditures guidance at a range of $80M-$100M is near the maintenance capital level. Depreciation, depletion and amortization is expected to be between $160M-$175M and cash interest expense in the range of $51M-$55M.
SESN

Hot Stocks

07:35 EST Sesen Bio provides manufacturing update on PPQ batches - The company said, "Manufacturing and release testing of the three drug substance PPQ batches has been completed and all quality acceptance criteria were met. Manufacturing of the three drug product batches has also been completed and release testing has been completed for the first and second batch, with all quality acceptance criteria met. Testing of the third drug product PPQ batch is expected to be completed in November 2020. Based on the results obtained thus far, the Company is confident that the remaining batch will also meet the required acceptance criteria in support analytical comparability. As part of the analytical comparability plan submitted to the FDA, the Company also committed to conduct extensive biophysical characterization and forced degradation testing on Vicineum manufactured using the proposed commercial process. These studies were completed in October 2020, and the Company believes the data demonstrates that clinical and commercial material are highly similar, providing strong support for analytical comparability."
ACB

Hot Stocks

07:35 EST Aurora Cannabis jumps 22% to $12.00 after reporting Q1 results
PFE

Hot Stocks

07:35 EST Pfizer has vaccine pacts with 'multiple countries,' in talks with more, CEO says - Pfizer CEO says he hopes to offer "equitable" vaccine distribution to the whole world. Pfizer CEO Albert Bourla continues to be interviewed on CNBC.
VRCA

Hot Stocks

07:35 EST Verrica Pharmaceuticals expects cash to support operations at least through 4Q21 - As of September 30, 2020, Verrica had aggregate cash, cash equivalents, and marketable securities of $71.9 million, which the Company believes will be sufficient to support planned operations at least through the fourth quarter of 2021.
CARS

Hot Stocks

07:33 EST Cars.com reports Q3 Average Monthly Unique Visitors of 25.3M, up 10% y/y - Reports Q3: Traffic (visits) of 158.8M, up 10% year over year. Dealer Customers grew to 18,130 at September 30, 2020 from 18,033 at June 30, 2020 and included growth in both marketplace and solutions only customers. Monthly average revenue per dealer was $2,183, rebounding to pre-COVID levels and up slightly compared to the prior-year period.
WVE

Hot Stocks

07:32 EST Wave Life Sciences expects cash, cash equivalents to fund operations into 2Q23 - Wave expects that its existing cash and cash equivalents, together with expected and committed cash from its existing collaboration, will enable the company to fund its operating and capital expenditure requirements into the second quarter of 2023.
PFE

Hot Stocks

07:31 EST Pfizer CEO says 'working at speed of science,' election had no bearing on timing - Pfizer CEO Albert Bourla said the U.S. presidential election timing had no bearing on the timing of the company's release earlier this morning of a first look at Phase 3 data on the effectiveness of the company's COVID-19 vaccine candidate. Bourla is being interview on CNBC following the data report.
STN

Hot Stocks

07:30 EST Stantec receives approval from TSX for its NCIB - Stantec announced that it has received approval from the Toronto Stock Exchange, or TSX, respecting the renewal of its Normal Course Issuer Bid, or NCIB. Pursuant to the NCIB documentation filed with the TSX, Stantec may purchase up to 5,605,224 common shares, representing approximately 5% of Stantec's 112,104,491 issued and outstanding common shares as of November 2, 2020. The purchases may commence on November 16, 2020 and will terminate no later than November 15, 2021. Except for block purchases permitted under the rules and policies of the TSX, the number of shares to be purchased per day will not exceed 56,146 or approximately 25% of the average daily trading volume for the six full calendar months ending October 31, 2020, which is 224,586 shares. Stantec will make the purchases on the open market through the facilities of the TSX or any alternative Canadian trading system, and the prices that Stantec will pay for any common shares will be the market price of such shares at the time of acquisition. All shares purchased by Stantec will be cancelled. Stantec also announced that, in connection with its intention to implement the NCIB, Stantec has renewed its automatic share purchase plan with a designated broker to allow for the purchase of its common shares under the NCIB, once effective, at times when Stantec normally would not be active in the market due to applicable regulatory restrictions or internal trading black-out periods.
AXGT

Hot Stocks

07:29 EST Axovant receives FDA clearance of IND for AXO-AAV-GM2 gene therapy - Axovant announced that the U.S. Food and Drug Administration has lifted its clinical hold and cleared the Investigational New Drug Application to initiate a registrational study of AXO-AAV-GM2 gene therapy to treat patients with Tay-Sachs disease and Sandhoff disease. AXO-AAV-GM2 is the first investigational gene therapy to achieve IND clearance for Tay-Sachs and Sandhoff diseases. The Company received a letter from the FDA indicating that it has satisfactorily addressed all issues related to the clinical hold. Axovant aims to advance the program through strategic partnerships with leading research organizations. The Company recently announced a partnership with Viralgen, an AskBio subsidiary, to support AAV-based vector manufacturing of clinical trial material for the registrational study. Additionally, through an existing genetic testing collaboration with Invitae, ongoing partnership with GM2 gangliosidosis patient groups, and collaboration with leading academic researchers at the University of Massachusetts Medical School and Massachusetts General Hospital, Axovant expects to begin patient identification and site startup activities in preparation for dosing children in the planned clinical study. AXO-AAV-GM2 is an investigational gene therapy for Tay-Sachs and Sandhoff diseases, which are rare, monogenic neurodegenerative lysosomal storage disorders caused by mutations in the genes that encode beta-Hexosaminidase A, HEXA and HEXB. Children affected by Tay-Sachs and Sandhoff diseases suffer from a progressively debilitating disease course and reduced life expectancy. AXO-AAV-GM2 delivers two vectors encoding the HEXA and HEXB genes directly to the central nervous system to produce a fully functional beta-Hexosaminidase A enzyme. In 2019, clinical evidence from two patients under an investigator-initiated study found that treatment with AXO-AAV-GM2 was generally well-tolerated and associated with improved bioactivity outcomes. In addition, the data demonstrated the attainment of normal neurodevelopmental milestones and improvement in myelination. AXO-AAV-GM2 has been granted Orphan Drug and Rare Pediatric Disease Designation by the FDA. The study will enroll both infantile and juvenile subjects with GM2 gangliosidosis in the U.S. The two-part trial, sponsored by Axovant, will consist of a dose ranging cohort evaluating the safe and efficacious dose of the gene therapy, followed by an efficacy cohort, both of which form the basis of the registrational program. Terence R. Flotte, M.D., Professor of Pediatrics and Dean at the University of Massachusetts Medical School, will serve as principal investigator on the clinical trial.
CLGX

Hot Stocks

07:28 EST CoreLogic rejecteds 'opportunistic lowball bid' by Senator/Cannae - "CoreLogic is firing on all cylinders and delivering outstanding financial and operational performance. Building on an excellent first half of 2020, we recently announced record third quarter financial results -- the strongest operational and financial performance in our history. We are delivering record revenues, record adjusted EBITDA and cash flow, and returning substantial capital to shareholders. We have high confidence this strong momentum will continue in 2021 and 2022. Our confidence reflects the robust underlying trends in the markets we serve, our increasing recurring revenue, substantial new business wins, and share gains which are driving accelerating growth in our non-mortgage business and continuing profitability increases. This backdrop of strong performance, increasing momentum, and high visibility into our growth trajectory puts the Company in a position of strength - and the Board's strategic review has already generated multiple written indications of interest in the $80+ per share range. Importantly, it has validated the Board's decision to unanimously reject Senator/Cannae's $66 per share proposal which dramatically undervalued CoreLogic. Yet, despite the uncontestable evidence that Senator/Cannae were wrong on value and not aligned with shareholders' best interests, they are continuing to push a proxy fight and seeking to undermine the Company's value and the Board's strategic review. Senator/Cannae are trying to install nominees who they paid to participate in this proxy fight in support of a $66 per share proposal - a proposal which has been clearly proven to be woefully inadequate. These nominees should not be trusted to maximize value for shareholders." said the company in a letter to shareholders.
ENGMF

Hot Stocks

07:27 EST Enthusiast Gaming plans listing on Nasdaq - Enthusiast Gaming Holdings announced that it has taken a significant step to enhance its investor profile by launching a new capital markets strategy focused on the United States. As a result, the Company has applied for and is in the process of preparing for a listing of its common shares on the NASDAQ Capital Market. Management of Enthusiast Gaming believes a NASDAQ listing will: provide additional opportunities to attract institutional and retail investors, allowing the Company to broaden its investor base; increase the visibility of the Company, its growth strategy, accomplishments and results to date; enhance the Company's brand in the US, thereby attracting additional partnership, sales, and M&A opportunities; and raise the Company's overall profile and ultimately enhance shareholder value. In advance of an anticipated listing on the NASDAQ, Enthusiast Gaming will file a Form 40-F Registration Statement with the United States Securities and Exchange Commission. The listing of the Company's common shares on the NASDAQ remains subject to the approval of the NASDAQ and the satisfaction of all applicable listing and regulatory requirements. The Company will continue to maintain the listing of its common shares on the Toronto Stock Exchange under the symbol "EGLX".
AAON

Hot Stocks

07:26 EST Aaon announces retirement of investor relations consultant Jerry Levine - AAON announced Jerry Levine recently notified the Company of his intent to retire and no longer provide investor relations consulting services for the Company, effective November 30, 2020. The Company also announced the hiring of Mr. Joseph Mondillo, as AAON's new Director of Investor Relations, effective November 16, 2020. Prior to joining AAON, Mr. Mondillo, had a 16-year career in the financial industry, including over 13-years at the small-cap research provider Sidoti & Co.
PFE

Hot Stocks

07:26 EST Bourla says 'not for Pfizer to decide' who gets vaccine first - Pfizer CEO Albert Bourla said "it is not for Pfizer to decide" who gets the company's COVID-19 vaccine first, but that is a decision for local health authorities. Bourla is being interviewed on CNBC after his company's release earlier this morning of a first look at Phase 3 data on the effectiveness of the company's COVID-19 vaccine candidate.
CLGX

Hot Stocks

07:25 EST CoreLogic receives 'indications of interest' valuing company at $80 per share - "CoreLogic provided an update on its review of strategic alternatives to correct misinformation in the market. The CoreLogic Board's review of strategic alternatives is progressing well. We have received written indications of interest in acquiring the Company at values of at least $80 per share from multiple competing parties. This is more than $1 billion -- or over 20% -- above the Senator/Cannae proposal. Interested parties are receiving due diligence access after executing customary confidentiality agreements. Additional credible parties have indicated they are preparing to join the process. CoreLogic is providing this information to correct the steady stream of baseless misinformation reportedly being pumped into the market by Senator/Cannae. Building off the record operating and financial performance over the past year, along with the growing strength of the business and multi-year forecasts, CoreLogic's Board has positioned shareholders to maximize value. Interested parties have cited the strength of our performance and positive multi-year," said the company in a statement.
BXRX

Hot Stocks

07:24 EST Baudax Bio reduces headcount by approx. 40 professionals - "Our adjusted plan is to focus on territories with high promise and with early indicators of adoption and usage with a reduced but very focused team during this pandemic of uncertain duration. This approach reduces the total company by approximately 40 professionals and includes additional cost reductions in other areas which we believe will better position the company to sustain our efforts. We would like to convey our gratitude to the employees who are leaving and who have contributed to the accomplishments of the Company of ultimate approval and launch of ANJESO, as well as forging a path for continued growth of the product," CEO Gerri Henwood said.
MIC

Hot Stocks

07:24 EST Macquarie Infrastructure to sell IMTT unit to Riverstone affiliate for ~$2.7B - On November 8, MIC entered into an agreement to sell its bulk liquid storage and handling business, IMTT, to an entity affiliated with Riverstone Holdings LLC for approximately $2.685B in cash and assumed debt. The transaction is expected to close in late 2020 or early 2021, subject to receipt of approvals and satisfaction of the conditions precedent set forth in the sales agreement. MIC intends to use all net proceeds, after payment of capital gains taxes and additional transaction related expenses and fees, to pay a special dividend of approximately $10.75 per share and to repay or offset holding company level debt of approximately $400M. Both the record date for the dividend and final amount remain subject to approval by the MIC board of directors, which is expected following the closing of the sale based on business and economic conditions at the time. Pro-forma for the completion of the sale and the payment of the special dividend, the company expects its leverage ratio to be approximately 4.3x net debt to EBITDA. On closing of the sale, MIC anticipates paying capital gains taxes of approximately $158M, additional transaction expenses of approximately $25M and a payment to the company's external Manager of approximately $28M pursuant to the Disposition Agreement entered into between the company and the Manager on October 30, 2019.
BCEI HPR

Hot Stocks

07:23 EST Bonanza Creek and HighPoint Resources enter into definitive merger agreement - Bonanza Creek Energy (BCEI) and HighPoint Resources (HPR) announced that they have entered into a definitive merger agreement to combine Bonanza Creek and HighPoint in a transaction valued at approximately $376M as of November 6. The transaction value is based on the equity to be issued to HighPoint equity holders, the equity and debt to be issued to HighPoint debt holders in connection with the Exchange Offer and the remaining debt to be assumed. Bonanza Creek will issue 9.8M shares of common stock and up to $100M in senior unsecured notes in the transaction. The transaction has been unanimously approved by the board of directors of each company. Materially increases Bonanza Creek's scale based on expected pro forma Q4 production of 50,000 Boe/d, 53% oil, and a rural Weld County leasehold position of 206,000 net acres. Under the terms of the definitive merger agreement, Bonanza Creek and HighPoint have agreed to commence a registered exchange offer and consent solicitation and simultaneous solicitation of a prepackaged plan of reorganization under Chapter 11 of the United States Bankruptcy Code. The Exchange Offer and Consent Solicitation will be conditioned on a minimum participation of not less than 97.5% of the aggregate outstanding principal amount of HighPoint senior unsecured notes.
GE

Hot Stocks

07:22 EST GE Healthcare, GenesisCare partner on patient outcomes in cancer, heart disease - GE Healthcare and GenesisCare, a provider of integrated cancer care globally and cardiovascular care in Australia, announced a strategic partnership aimed at improving patient outcomes for the two biggest health burdens globally, cancer and heart disease. GE Healthcare will supply and service the latest CT, MRI, PET/CT, SPECT, digital mammography, and Ultrasound equipment to GenesisCare's 440+ cancer and cardiovascular disease treatment centers across Australia, the U.S., the U.K. and Spain. GenesisCare recently acquired U.S. integrated cancer care provider, 21st Century Oncology, increasing access to cancer care for patients across U.S. communities as well as its global network. Separately, the companies plan to explore further partnership on research activities, with the aim of improving clinical care and outcomes for millions of patients around the world, through technology, education, care pathway development, and theranostics-an innovative and personalized approach that combines molecular imaging and radiotherapy to seek and destroy advanced cancers without damaging healthy tissue.
PFE BNTX

Hot Stocks

07:21 EST Pfizer CEO says pediatric COVID vaccine study will follow current studies - Pfizer (PFE) CEO Albert Bourla is being interviewed on CNBC after the company's release earlier this morning of the first set of results from the company and BioNTech SE's (BNTX) Phase 3 clinical study of their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2.
EXR JPM

Hot Stocks

07:19 EST Extra Space Storage makes $300M preferred stock investment in Jernigan Capital - Extra Space Storage (EXR) announced it made a $300M investment in preferred stock of Jernigan Capital in connection with the acquisition of JCAP by affiliates of NexPoint Advisors. The previously announced acquisition was approved by JCAP stockholders on October 20 and closed on Friday, November 6. Extra Space's preferred stock investment consists of a $200M tranche, which will yield 10% per annum and a $100M tranche which will yield 12% per annum, for a blended yield of 10.7% per annum. J.P. Morgan (JPM) served as financial advisor and Latham & Watkins served as legal counsel to Extra Space in connection with this transaction.
PFE BNTX

Hot Stocks

07:18 EST Pfizer CEO sees 50M doses of vaccine available by end of 2020, 1.3B by end 2021 - Pfizer (PFE) CEO Albert Bourla is being interviewed on CNBC after the company's release earlier this morning of the first set of results from the company and BioNTech SE's (BNTX) Phase 3 clinical study of their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2.
ARCT

Hot Stocks

07:18 EST Arcturus Therapeutics announces interim ARCT-021 study results - Arcturus Therapeutics announced interim clinical study results from its ongoing Phase 1/2 study of ARCT-021, its vaccine candidate for COVID-19. The company also announced new manufacturing financial support and potential vaccine purchases up to $220M from Singapore's Economic Development Board, or EDB. ARCT-021 is being developed in collaboration with Duke-NUS Medical School and ongoing Phase 1/2 development is being conducted in Singapore. ARCT-021 combines self-transcribing and replicating mRNA with Lunar lipid-mediated delivery technology, which is designed to enhance and extend antigen expression, enabling vaccination at lower doses. The ongoing Phase 1/2 randomized, double-blinded, placebo-controlled study is evaluating the safety, tolerability and immunogenicity of multiple dose levels of ARCT-021. Study subjects receive either placebo, or ARCT-021 at doses in the range of 1 microgram to 10 microgram per injection in either a single dose or prime-boost regimen. The study is fully enrolled with 106 subjects, including older adult subjects. To date, 78 subjects have received at least one injection of ARCT-021, 36 subjects have received two injections and 28 subjects have received placebo. Preliminary results are currently available from all single dose cohorts and the 5 microgram younger adult prime-boost cohort up to at least day 36, with most subjects having completed day 57 post-injection. Based on interim study results, a robust anti-spike protein IgG immune response was observed at all doses evaluated. PRNT50 GMT levels for neutralizing antibodies were within the range of titers observed in COVID-19 patient convalescent plasma. Furthermore, anti-spike IgG antibody titers have been dose-dependent, and increased through approximately day 43, confirming the effect seen in preclinical studies for Starr mRNA which exhibited increasing antibody titers over extended periods of time. Cytokine staining and ELISpot tests showed T cell responses to multiple peptide pools derived from the SARS-CoV-2 spike protein. The CD4+ response was Th1 dominant and the CD8+ response includes reactivity to the receptor binding domain. ARCT-021 was generally well tolerated and had a favorable local and systemic adverse event, or AE, profile. The majority of AEs have been mild; there have been no moderate or severe fevers at any dose and no severe injection site reactions at doses being contemplated for advancement. No subjects have withdrawn from the study and there have been no serious adverse events deemed to be treatment related. The study remains ongoing and the company intends to provide additional results at a later date. The company's lyophilized drug product remains on track for Phase 3 implementation. The novel lyophilization process technology has been successfully transferred to a cGMP manufacturing facility. Arcturus recently signed an agreement with Recipharm to support the manufacture of ARCT-021. The company is in discussions with the Singapore Health Sciences Authority to advance ARCT-021 into later stage clinical studies. Interactions with additional agencies are expected within the next few weeks. The current plan anticipates testing a single dose regimen at 7.5 microgram, as well as prime-boost regimens. Arcturus announced a manufacturing support agreement with Singapore's EDB that includes a limited recourse loan of $45M and terms for ARCT-021 vaccine purchases of up to $175M. The EDB will provide the $45M within 60 days contingent on delivery of certain documentations. The proceeds will be used for the purchase of equipment, materials and services related to the manufacture of our vaccine. Under the terms of the agreement, the loan will be repaid through royalties on future ARCT-021 commercial sales. If ARCT-021 does not obtain regulatory approval, the loan will be forgiven. Additionally, Arcturus and the EDB have agreed to terms providing the EDB with the right to purchase up to $175M of ARCT-021 vaccine at pre-negotiated prices, with shipments expected to begin in Q1 of 2021.
PFE BNTX

Hot Stocks

07:16 EST Pfizer CEO sees Phase 3 COVID vaccine trial completed by 'end of the month' - Pfizer (PFE) CEO Albert Bourla is being interviewed on CNBC after the company's release earlier this morning of the first set of results from the company and BioNTech SE's (BNTX) Phase 3 clinical study of their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2.
CASY

Hot Stocks

07:11 EST Casey's General Stores to acquire Buchanan Energy for $580M in cash - Casey's General Stores announced an agreement to acquire Buchanan Energy, owner of Bucky's Convenience Stores, in an all-cash transaction for $580M. The purchase price includes tax benefits valued at $80M for a net after-tax purchase price of $500M. Buchanan Energy and Bucky's Convenience Stores were founded as a family-owned and operated business in 1980. They operate convenience stores primarily in Illinois and Nebraska. Casey's acquisition of Buchanan Energy will include 94 retail stores and 79 dealer locations, as well as multiple parcels of real estate for future new store construction, which will increase Casey's footprint to over 2,300 stores. The company said the acquisition will enhance Casey's presence in these attractive markets and enables the company to bring Casey's offerings to a broader group of consumers. The transaction will also include a dealer network of stores where Casey's will manage fuel supply agreements to these stores. The company will finance the transaction with a combination of cash on hand, revolver capacity and bank financing. The net investment of $500M represents a multiple of 10.6 times Bucky's last 12 months of EBITDA. The company expects to achieve $23M in annual synergies by the third year. The transaction is anticipated to close by the end of calendar year 2020, subject to customary closing conditions and regulatory approval.
ZNTL

Hot Stocks

07:11 EST Zentalis expects cash to fund operations into 2023 - As of September 30, 2020, Zentalis had cash, cash equivalents and marketable securities of $367.4 million. Zentalis expects that its existing cash, cash equivalents and marketable securities, which includes the net proceeds of approximately $155.2 million from the follow-on offering, will enable the Company to fund its operating expenses and capital expenditure requirements into 2023.
BR AXP

Hot Stocks

07:11 EST Broadridge names Edmund Reese as CFO, effective November 30 - Broadridge Financial (BR) announced that Edmund Reese has been appointed CFO, effective November 30. Reese joins Broadridge from American Express (AXP), where he most recently served as Senior Vice President and CFO of the Global Consumer Services Group, the company's largest business unit.
MORF

Hot Stocks

07:09 EST Morphic Holding expects cash to be sufficient through end of 2022 - As of September 30, 2020, Morphic had cash, cash equivalents, and marketable securities of $213.1 million, compared to $237.0 million at the end of 2019. Through utilization of at-the-market offerings during the third quarter of 2020, Morphic raised net proceeds of $6.3 million. Morphic believes its cash, cash equivalents, and marketable securities balance as of September 30, 2020 will be sufficient to fund operating expenses and capital expenditure requirements into at least the end of 2022.
CNC

Hot Stocks

07:08 EST Centene to acquire Apixio, terms not disclosed - Centene announced it has signed a definitive agreement to acquire Apixio, a healthcare analytics company offering Artificial Intelligence technology solutions. The transaction is subject to regulatory approvals and is expected to close by the end of 2020. Apixio will remain an operationally independent entity as part of Centene's Health Care Enterprises group to continue bringing value to its clients and the industry, while also realizing the benefits of enhanced scale with Centene.
PLUG

Hot Stocks

07:06 EST Plug Power reaffirms 2024 gross billings guidance $1.2B - The company said, "The annualized rate based on Q3 deployments of over 4,000 units represents almost 65% of the annual deployment forecast of 25,000 units in the material handling market in 2024. Considering our 2021 gross billing guidance of $450 million, which we are also reaffirming, we believe we are well on our way to deliver on our 2024 targets of $1.2B in gross billings, $200M in operating income, and over 20% Adjusted EBITDA."
BKI

Hot Stocks

07:06 EST Black Knight sees FY20 adjusted EPS $2.03-$2.07, consensus $1.98 - Sees FY20 revenue $1.229B, consensus $1.19B. Sees FY20 Adjusted EBITDA $603M-$608M. Following the closing of the Optimal Blue acquisition, Black Knight's updated FY20 outlook.
MCD

Hot Stocks

07:06 EST McDonald's says nearly all restaurants globally open for business - The company said, "The Company has continued to follow the guidance of expert health authorities to ensure the appropriate precautionary steps are taken to protect the health and safety of our people and our customers. The Company began the third quarter with nearly all restaurants globally open for business, and which currently remain open as of the date of filing. However, as a result of COVID-19 resurgences, since September, there have been numerous instances of government restrictions on operating hours, limited dine-in capacity in most countries and, in some cases, mandated dining room closures. These restrictions are impacting most of the Company's key markets outside of the U.S., including France, Germany, Canada and the U.K. The Company expects some restrictions in various markets so long as the COVID-19 pandemic continues."
PLUG

Hot Stocks

07:05 EST Plug Power raises 2020 gross billings view $325M-$330M from $310M - The company said, "We remain focused on building the green hydrogen economy in an electrified world. Plug Power is raising the 2020 full-year gross billings guidance to $325M-$330M from $310M. We are pleased to report that the proforma Adjusted EBITDA margin in Q3 2020 of 19%, as outlined above, is approaching our target Adjusted EBITDA margin of 20% by 2024. The improvement in the 3rd quarter 2020 is driven by growth in sales, ongoing cost reductions, and the increasing leverage on operating costs."
MCD

Hot Stocks

07:04 EST McDonald's reports Q3 U.S. comparable sales up 4.6%
BMY

Hot Stocks

07:02 EST Bristol-Myers: Phase 2 study evaluating deucravacitinib met primary endpoint - Bristol Myers Squibb announced results from an ongoing Phase 2 study evaluating the safety and efficacy of deucravacitinib 6 mg or 12 mg once daily, compared with placebo in adults with active psoriatic arthritis. The study met the primary endpoint of at least a 20% improvement in signs and symptoms of disease at Week 16. Patients treated with deucravacitinib 6 mg or 12 mg demonstrated significantly greater ACR 20 responses versus placebo at Week 16, respectively. Treatment with deucravacitinib also led to significant improvements on key secondary endpoints relevant for patients, including improvement from baseline in the Health Assessment Questionnaire-Disability Index and change from baseline in the Physical Component Summary Score of the Short Form Health Survey-36 Item Questionnaire.
TXMD

Hot Stocks

07:01 EST TherapeuticsMD begins process to divest vitaCare Prescription Services - TherapeuticsMD announced the commencement of a process to divest vitaCare Prescription Services. In recent months, the COVID-19 pandemic has highlighted the value of pharmaceutical companies being able to connect directly with patients. The Company's vitaCare Prescription Services model is designed to make a complex process of filling prescriptions simple, cost-effective, and stress free for patients.The Company's goal is to unlock substantial value for its shareholders by divesting vitaCare to a partner who can capitalize the business opportunity. Based on initial indications received, the Company believes the enterprise value of vitaCare with the right partner can be upwards of $100M, and, depending on the ultimate transaction structure, could potentially generate at least $50M in non-dilutive proceeds to the Company, while also retaining an interest in the newly-capitalized business. The Company intends that vitaCare's existing dedicated management team will continue to operate the business to ensure the current level of service to TherapeuticsMD and new customers. The Company has retained Greenhill & Co. as an advisor for the transaction.
ZYNE

Hot Stocks

06:57 EST Zynerba believes current cash is sufficient until late Q4 of FY21 - Management believes that the current cash and cash equivalents is sufficient to fund operations and capital requirements until late in the Q4 of FY21.
BCEI HPR

Hot Stocks

06:51 EST Bonanza Creek to acquire HighPoint Resources in $376M deal - Bonanza Creek Energy (BCEI) and HighPoint Resources (HPR) announced that they have entered into a definitive merger agreement to combine Bonanza Creek and HighPoint in a transaction valued at approximately $376M as of November 6. The transaction value is based on the equity to be issued to HighPoint equity holders, the equity and debt to be issued to HighPoint debt holders in connection with the Exchange Offer and the remaining debt to be assumed. Bonanza Creek will issue 9.8M shares of common stock and up to $100M in senior unsecured notes in the transaction. The transaction has been unanimously approved by the board of directors of each company. The transaction is expected to close in the first quarter of 2021 under the Exchange Offer and Consent Solicitation or no later than the second quarter of 2021 under the Prepackaged Plan.
RETA

Hot Stocks

06:51 EST Reata Pharma announces results from Phase 3 Cardinal study - Reata Pharmaceuticals announced that the Phase 3 CARDINAL study of bardoxolone methyl, or bardoxolone, in patients with chronic kidney disease, or CKD, caused by Alport syndrome met its primary and key secondary endpoints at the end of Year 2. At Week 100, in the intent-to-treat, or ITT, population, which included estimated glomerular filtration rate, or eGFR, values for patients who either remained on or discontinued study drug, patients treated with bardoxolone had a statistically significant improvement compared to placebo in mean change from baseline in eGFR of 7.7 mL/min/1.73 m2. In the modified ITT analysis, which assessed the effect of receiving treatment by excluding values after patients discontinued treatment, patients treated with bardoxolone had a statistically significant improvement compared to placebo in mean change from baseline in eGFR at Week 100 of 11.3 mL/min/1.73 m2. At Week 104, patients in the ITT population treated with bardoxolone had a statistically significant improvement compared to placebo in mean change from baseline in eGFR of 4.3 mL/min/1.73 m2. B
NOMD NSRGY

Hot Stocks

06:49 EST Nomad Foods to acquire Findus Switzerland for about EUR110M - Nomad Foods (NOMD) announced that it has entered into an agreement to acquire Findus Switzerland from Froneri International Ltd. and certain intellectual property from an affiliate of Nestle S.A. (NSRGY) for aggregate consideration of approximately EUR110M on a debt-free, cash-free basis. Findus is the leading frozen food brand in Switzerland with a portfolio of value-added frozen products across categories including fish, vegetables and ready meals. The acquisition will expand Nomad Foods' geographic reach into Switzerland, a new and sizable market, providing a natural extension for our Findus product offering and brand family with an attractive entry point for Green Cuisine. This transaction will unify Nomad Foods' ownership of the iconic Findus brand across Europe where it currently operates under the Findus brand in Italy, France, Spain, Sweden, Norway, Finland and Denmark. Nomad Foods anticipates multiple sources of value creation including the opportunity to realize commercial and procurement synergies. The transaction is expected to be immediately accretive to Adjusted EPS. The purchase price is expected to be funded through cash on hand, and the transaction is expected to be completed in the beginning of 2021.
PFE BNTX

Hot Stocks

06:49 EST Pfizer, BioNTech vaccine found to be over 90% effective in preventing COVID-19 - Pfizer (PFE) and BioNTech SE (BNTX) announced their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee from the Phase 3 clinical study. After discussion with the FDA, the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases. Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC performed its first analysis on all cases. The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at seven days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule. As the study continues, the final vaccine efficacy percentage may vary. The DMC has not reported any serious safety concerns and recommends that the study continues to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide. Pfizer and BioNTech are continuing to accumulate safety data and currently estimate that a median of two months of safety data following the second (and final) dose of the vaccine candidate - the amount of safety data specified by the FDA in its guidance for potential Emergency Use Authorization - will be available by the third week of November. Additionally, participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose. Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced. Based on supply projections, we expect to supply globally up to 50 million vaccine doses in 2020 and manufacture up to 1.3 billion doses in 2021. Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication. "Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine's ability to prevent COVID-19. We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today's news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks," said Dr. Albert Bourla, Pfizer Chairman and CEO.
BRO

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06:49 EST Brown & Brown acquires all assets of CoverHound - J. Scott Penny, Chief Acquisitions Officer of Brown & Brown, and Keith Moore, the CEO of CoverHound and its wholly owned subsidiary CyberPolicy, announced that a subsidiary of Brown & Brown, has acquired substantially all of the assets of CoverHound. CoverHound is a leading digital insurance marketplace for individuals and small businesses.
PFE BNTX

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06:47 EST Pfizer, BioNTech vaccine found to be over 90% effective in preventing COVID-19
BCEI HPR

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06:47 EST Bonanza Creek to acquire HighPoint Resources in $376M deal
DNN

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06:37 EST Denison Mines to resume Wheeler River formal environmental assessment process - Denison Mines announced its decision to restart the formal environmental assessment, or EA, process for the 90% owned Wheeler River Uranium Project effective January 2021. The decision to resume the EA process marks the end of the temporary suspension announced in March amidst the social and economic disruption that emerged as a result of the COVID-19 pandemic. David Cates, Denison's president & CEO, commented, "In the coming days, formal notifications will be submitted to the Canadian Nuclear Safety Commission ('CNSC') and the Saskatchewan Ministry of Environment ('MOE')to restart the EA process. These notifications will inform the regulators of Denison's intention to resume various activities designed to meet the regulatory requirements for an Environmental Impact Statement ('EIS') supporting the advancement of Wheeler River as Canada's first In-Situ Recovery ('ISR') uranium mine. With over $29 million in cash on the balance sheet at the end of October, Denison is well funded to resume the Wheeler River EA process and is currently finalizing its plans for the resumption of the EA as part of the Company's 2021 budgeting process. A key milestone for the EA process in 2021 is expected to be the resumption of community engagement activities, adapted to reflect COVID-19 protocols and best practices, to facilitate information sharing with interested parties. Additionally, advancing the EA process will involve the completion of third-party technical studies and assessments, ahead of the preparation and submission of a draft EIS, which is currently targeted for early 2022."
BCOR

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06:36 EST Blucora provides 2021 tax preparation outlook - The company said, "Due to the extended tax season in 2020, we believe it is more helpful to provide a full-year 2021, rather than first half, outlook for tax preparation. As we continue to improve our product features, implement our new marketing approach and prepare to launch our new hybrid-assisted offering, we feel confident approaching the new tax year. At the same time, given our planned transition from price-driven growth to unit-driven growth, supplemented by ARPU benefits of incremental offerings, and the longer guidance period, we want to be appropriately cautious in our outlook. Given these and other factors, we are targeting low single digit revenue growth in tax preparation for full-year 2021 and reaffirming our prior segment operating income outlook, which calls for a minimum of $20 million improvement vs. 2020."
APVO

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06:28 EST Aptevo announces complete remission in second patient in APVO436 trial cohort - Aptevo Therapeutics provided an update on its ongoing APVO436 Phase 1 clinical trial. APVO436 is a novel anti-CD123 x anti-CD3 targeted investigational bispecific antibody therapy being evaluated for the treatment of acute myeloid leukemia, or AML, and myelodysplastic syndrome, or MDS, in a Phase 1/1b open-label, dose-escalation study evaluating the safety and pharmacokinetic profile. Aptevo received preliminary data regarding cohort 6, which indicated complete remission in a second patient, in addition to the one previously announced. In total, there are now two patients with clinical remission in cohort 6. The data received also showed one patient exhibiting stable disease status, and six patients where the disease had progressed. A total of nine patients were listed in cohort 6 of the clinical trial. Patient bone marrow blasts were 33% at screen, exhibited a rise in blasts to 46% after the first cycle of treatment. Subsequently, the bone marrow blasts dropped to 8% after the second cycle, and to 4% after the fourth cycle of treatment. The patient's platelet count and absolute neutrophil count met complete remission criteria. "It is very encouraging that two complete remissions have been observed in Cohort 6, as we are now enrolling in cohort 8," said Marvin White, President and CEO of Aptevo Therapeutics. "We are now in a critical phase of the study, as pharmacokinetic modelling suggests that dosing in cohorts 5 through 8 is in a therapeutic range, which could result in potential clinical activity of the drug. We look forward to continuing the dose escalation and monitoring potential clinical responses as we advance through the upcoming dose cohorts," concluded White.
KBR

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06:15 EST KBR secures $47M recompete to assist PMA-265 with FMS to Kuwait, Finland - KBR has secured a $47M recompete to assist the U.S. Navy's F/A-18 and EA-18G Program Office, or PMA-265, with foreign military sales, or FMS, to Kuwait and Finland. The Naval Air Warfare Center Aircraft Division, or NAWCAD, awarded this cost-plus-fixed-fee contract. KBR will continue to provide program management, engineering, technical and financial services to PMA-265 as it supports the F/A-18 air vehicle, subsystems, armament, engine and airborne weapons for these allied nations. Specifically, the company will assess program requirements; develop, review and analyze FMS case documentation; and participate in technical reviews. It will also plan and analyze flight test programs; monitor the progress of software; develop estimates of financial requirements; and support training systems. This work will primarily take place in Patuxent River, Maryland, and includes a one-year base and four option years.
GHIV

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06:14 EST Gores Holdings IV: UWM plans to issue annual dividend of 40c per share - Gores Holdings IV announced United Wholesale Mortgage's intention to adopt a policy of issuing a regular annual dividend of 40c per share as part of its capital allocation strategy following the consummation of the previously announced pending business combination with Gores Holdings IV.
TPC

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06:10 EST Tutor Perini awarded $54M contract to complete project in Los Angeles - Tutor Perini announced that its subsidiary, Rudolph and Sletten, has been awarded $54M to complete a mixed-use project in Los Angeles. Located along Eighth Street, Oxford Avenue and Serrano Avenue in Los Angeles, The Rise Koreatown is being developed by Florida-based Rescore Property. Designed by Nadel Architecture, the project is a seven-story mixed-use complex with 364 rental apartment units in five levels over one level of parking and a 52,000 square-foot ground floor retail area. There are three levels of subterranean parking adding to the project total of 798,000 square feet. Rudolph and Sletten replaced another general contractor who was transitioned off the job. Rudolph and Sletten resumed construction in July 2020 with completion scheduled for November 2021. The overall project value is $101M; Rudolph and Sletten's contract value is $54M, the remaining amount to complete the project. The contract value was included in the Company's Q3 backlog.
TSN

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06:09 EST Tyson Foods announces European launch of Raised & Rooted brand - Tyson Foods announced the European launch of its plant-based protein brand, Raised & Rooted. This is the first expansion of the Raised & Rooted brand outside the U.S., in the brand's pursuit to be the most loved alternative protein brand in the world. The European Raised & Rooted range, which include five varieties of plant-based products, will be introduced through foodservice customers across Europe.
PCH

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06:04 EST PotlatchDeltic promotes Eric Cremers to CEO - PotlatchDeltic Corporation's board of directors announced that Eric J. Cremers, currently the company's president and COO, has been appointed president and CEO of the company, effective January 1, 2021. Michael J. Covey who joined the company in 2006 as president and CEO and who has served as chairman and chief executive officer since 2007, will continue in his role as a director, serving as executive chairperson of the board of directors. Cremers joined the company in 2007 as vice president and CFO and has held various executive roles at the company, including serving as the company's president and COO since 2013. He was appointed to the board of directors in 2013 and will continue to serve as a director.
ACIU WXXWY

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05:45 EST AC Immune, WuXi Biologics expand strategic partnership on TDP-43 antibodies - AC Immune (ACIU) and WuXi Biologics (WXXWY) unveiled plans to accelerate advancement of AC Immune's TDP-43 antibody into clinical development for NeuroOrphan indications. This next phase of the strategic partnership between the companies builds on AC Immune's proprietary drug discovery and development platforms and WuXi Biologics' expertise in manufacturing biologics. A particular focus is developing AC Immune's clinical antibody candidate to ensure it has high-affinity for TDP-43 and is capable of preventing the intercellular spread of toxic species. With no disease modifying therapies currently available that target TDP-43 there is significant unmet need and market potential.
CALT

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05:41 EST Calliditas Therapeutics says Part A of NefIgArd trial met its primary objective - Calliditas Therapeutics announced topline results from Part A of the global Phase 3 clinical trial NefIgArd, which investigated the effect of Nefecon versus placebo in patients with primary IgA nephropathy, or IgAN. The trial met its primary objective of demonstrating a statistically significant reduction in urine protein creatinine ratio, UPCR or proteinuria, after nine months of treatment with 16 mg of Nefecon compared to placebo, with significant continued improvement at 12 months. The trial also met the key secondary endpoint showing a statistically significant difference in estimated glomerular filtration rate, or eGFR, after nine months of treatment with Nefecon compared to placebo. Collectively the efficacy data from nine months treatment with 16 mg of Nefecon indicated a significant and beneficial effect on key factors correlated to the progression to end stage renal disease, or ESRD, for IgAN patients. In addition, the trial showed that Nefecon was generally well-tolerated. On the basis of these results, Calliditas plans to submit for accelerated approval with the FDA in Q1 2021 followed by a submission for conditional approval with the European Medicines Agency in the first half of 2021. Subject to approval by the FDA, Calliditas intends to commercialize Nefecon for IgAN by itself in the United States and through collaborations in other regions. The analysis included 199 patients diagnosed with primary IgA Nephropathy and who were on a background of optimised and stable renin-angiotensin system, or RAS inhibitor therapy. The patients were randomised in a 1:1 ratio into one of two treatment groups - Nefecon 16 mg/day or placebo - and treated orally for nine months daily. The primary endpoint analysis showed a 31% mean reduction in the 16 mg arm versus baseline, with placebo showing a 5% mean reduction versus baseline, resulting in a 27% mean reduction at 9 months of the 16 mg arm versus placebo. The results indicate that Nefecon was generally well-tolerated and were consistent with the known safety profile of Budesonide. The number of withdrawals in the trial was significantly less than what was seen in the Phase 2b NEFIGAN trial. The NefIgArd trial is continuing on a blinded basis with patients continuing in the observational Part B of the trial for a 12 month follow up period post their completion of Part A. Calliditas is recruiting an additional 160 patients for inclusion in Part B during 2020 and aims to complete the recruitment in Q4 or Q1 2021, depending on the impact of COVID-19.
GNHAF

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05:36 EST Vifor Pharma, Angion sign licensing agreement for ANG-3777 commercialization - Vifor Pharma and Angion announced the signing of a licensing agreement for the commercialization of ANG-3777, currently developed for treatment of delayed graft function, or DGF, and cardiac surgery-associated acute kidney injury, or CSA-AKI. ANG-3777 was engineered to mimic the biological activity of HGF, activating pathways in the body's natural organ repair process following an acute organ injury. Under the terms of the agreement, Vifor Pharma will receive an exclusive global license, excluding China, Taiwan, Hong Kong and Macau, for all ANG-3777 nephrology indications. Angion will receive up to $80M which includes a $30M upfront payment, a $30M equity investment and $20M in clinical study milestone payments. Additionally Angion is eligible to receive up to $260M in market access related milestones upon approval in U.S. and EU, further payments in the form of sales milestones, and tiered royalties on global net sales up to 40% at the high end of the royalty range. Angion will be responsible for conducting the ongoing nephrology-focused clinical development programs. Angion and Vifor Pharma will share responsibilities for regulatory filings in the licensed territories and Vifor Pharma will be responsible for all commercialization activities related to nephrology indications in all licensed territories.
ORPH

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05:33 EST Orphazyme submits arimoclomol MAA to EMA - Orphazyme announced it has submitted a marketing authorization application, or MAA, to the European Medicines Agency, or EMA, for its investigational product candidate arimoclomol for the treatment of Niemann-Pick disease Type C, or NPC. This follows Orphazyme's U.S. NDA seeking approval for arimoclomol for the treatment of NPC that is under priority review with the FDA. Arimoclomol has been granted orphan drug designation in Europe and the U.S. Additionally, arimoclomol has FDA fast track and breakthrough therapy designations for NPC as well as rare pediatric disease designations in the U.S.
OBSV

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05:31 EST ObsEva CEO Ernest Loumaye to retire, Brian O'Callaghan to succeed - ObsEva announced that ObsEva's board has appointed Brian O'Callaghan, to succeed Ernest Loumaye, as CEO and member of the company's executive committee, effective December 1. He will also be proposed for election on ObsEva's board at next company annual meeting. Ernest Loumaye, co-founder and CEO of ObsEva, has expressed his wish to retire from the day to day operation. He will continue to serve as a member of ObsEva's board and will work to ensure a transition with Brian O'Callaghan. O'Callaghan is a life science executive who brings experience to ObsEva, having held senior positions within a number of public and private pharmaceutical and biotechnology companies, in both Europe and the United States. O'Callaghan managed businesses and programs across multiple therapeutic areas from concept through commercialization.
SKSBF

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05:27 EST Skanska to divest ownership stake in ERC in Virginia for $625M - Skanska has signed a binding sale and purchase agreement, or SPA, for its 50% ownership stake in Elizabeth River Crossings, or ERC, in Hampton Roads Metropolitan Area, Virginia, for gross sale proceeds of $625M. The buyer is Abertis, and Manulife Investment Management, on behalf of John Hancock Life Insurance. The transaction will be recorded at closing under Central stream, which is expected to be in Q4. ERC was established by Skanska and Macquarie Infrastructure Partners II, a fund managed by Macquarie Infrastructure & Real Assets in 2012 as part of a public-private partnership with the Virginia Department of Transportation, to rehabilitate the existing Downtown and Midtown Tunnels, construct a new, parallel Midtown Tunnel, extend the Martin Luther King Freeway to I-264, and assume all tolling, operations and maintenance of these facilities through 2070. The construction of the new Midtown Tunnel was completed by a Skanska-led construction joint venture in 2016, almost a year ahead of schedule. Completion of the sale is subject to regulatory approvals and other consents. The final purchase price may be adjusted as a result of certain conditions. Skanska will announce the final amount and closing of the divestment in connection with the completion of regulatory approvals and other consents and the satisfaction of SPA conditions. It is anticipated that completion of the divestment will take place by the end of 2020, with MIP II's divesting its 50% managed equity stake in ERC also at such time.
ESALY

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05:20 EST Eisai presents latest BAN2401 data at CTAD - BioArctic AB announced data on the drug candidate BAN2401, which were presented by the company's partner Eisai at the Clinical Trials on Alzheimer's Disease conference, or CTAD, November 4-7. The presentations included study design and initial screening results from the Phase 3 study AHEAD 3-45, the baseline characteristics of currently enrolled Alzheimer's disease patients in the Phase 3 study Clarity AD, and an update on the effect of BAN2401 on amyloid brain levels and the ARIA-E frequency for patients enrolled in the Phase 2b open label extension study. A presentation on the clinical study design and initial screening results from the newly initiated Phase 3 study AHEAD 3-45, in individuals with preclinical Alzheimer's disease showed that the initial screening results were according to expectations, with more participants joining the A45 trial than the A3 trial. When the study is fully recruited the aim is to have 1000 participants in the A45 trial and 400 in the A3 trial. A presentation of currently enrolled participants in the ongoing Phase 3 study Clarity AD study in early Alzheimer's disease patients revealed that the baseline characteristics were consistent with those in the Phase 2b study, and representative of an early Alzheimer's disease population. These characteristics were presented from the 1222 subjects enrolled in the study as of the beginning of October. Two presentations covered different aspects of the Phase 2b core and open-label extension study in early Alzheimer's disease patients. The data showed that patients who received placebo in the Phase 2b core study entered the open-label extension study with high brain amyloid levels. In the open-label extension study, in patients previously on placebo, a rapid decrease in amyloid levels was observed after three months of treatment with BAN2401 10 mg/kg every other week. Further decreases were observed after six- and twelve-months treatment. After twelve months the observed effect was comparable to the results in patients who received this dose of BAN2401 in the Phase 2b core study. For the patients who received BAN2401 10 mg/kg either monthly or every other week in the core study, the amyloid levels in the brain were already low when they entered the open-label extension study and remained low. Also, the incidence of ARIA-E, a form of cerebral edema that occurs in patients treated with anti-amyloid monoclonal antibodies for Alzheimer's disease, remained on a similar level in the open-label extension study as in the core Phase 2b study, at less than 10%. These data are consistent with and expands upon the preliminary results reported at the Alzheimer's Association International Conference in July.
AKCA IONS

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05:16 EST Akcea Therapeutics announces access to volanesorsen on the NHS in Scotland - Akcea Therapeutics (AKCA), a wholly owned subsidiary of Ionis Pharmaceuticals (IONS), announced that the Scottish Medicines Consortium, or SMC, has enabled access to volanesorsen on the National Health Service, or NHS, in Scotland for the treatment of familial chylomicronaemia syndrome, or FCS. This decision will allow patients in Scotland with this rare and life-threatening condition to access the treatment through NHS Scotland. SMC's acceptance follows recent approval from the National Institute for Health and Care Excellence, or NICE, for the use of volanesorsen on the NHS in England. Volanesorsen was evaluated by the SMC under the ultra-orphan medicines pathway, a new system for the assessment of medicines for extremely rare diseases, which was introduced at the start of this year. This means that eligible patients will be able to access volanesorsen through NHS Scotland while additional clinical effectiveness data are gathered. The SMC will review this data after three years and make a final decision on its routine use in NHS Scotland. Volanesorsen will be the second treatment that Akcea Therapeutics has made available on the NHS in Scotland in the past 18 months. Volanesorsen, a product of Ionis' proprietary antisense technology, is designed to reduce the production of ApoC-III, a protein that regulates plasma triglycerides and may also affect other metabolic parameters.
NTRS

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05:12 EST Northern Trust selected by Emerald to provide fund administration - Northern Trust has been selected by Emerald Technology Ventures to provide fund administration, global custody and banking services for its sixth new fund launch - the Guernsey-domiciled Emerald Global Water Impact Fund. Northern Trust's suite of asset servicing solutions provides Emerald with the operational infrastructure to support its global investment reach. The $100M fund is making investments in early and expansion stage companies in the water technology sector with the aim of solving global water problems. Investments will be largely aligned with the United Nations sustainable development goals including conserving water resources, improving resource efficiency and adapting to climate change with exposure to Europe, North America and Asia-Pacific.
NOK

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05:09 EST Nokia announces three-year services deal with A1 Austria - Nokia announced a services deal with A1 Austria. In this three-year contract, started earlier in 2020, Nokia is providing its industrial-grade private wireless technology and services for all existing and new A1 Austria LTE and 5G enterprise campus network deployments. As part of the deal, Nokia will provide operational support and care for all existing campus networks, ensuring adherence to service level agreements, or SLAs, and quality of services, or QoS, requirements. A1 and Nokia have already deployed a number of private wireless campus networks in Austria, including installations at Magna Steyr, Vienna Airport and 5G Playground Carinthia. Nokia is now the technology partner of A1 Austria. In addition to the services contract, Nokia provides A1 Austria the infrastructure, software and services for setting up the private LTE networks. This includes a micro core network, AirFrame servers, small or macro cells, as well as professional services.
ICE

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05:04 EST IntercontinentalExchange to launch IFAD, Murban crude futures in March of 2021 - IntercontinentalExchange announced that it plans to launch ICE Futures Abu Dhabi, or IFAD, and the world's first futures contracts based on Murban crude oil on March 29, 2021, subject to the completion of regulatory approvals. In November 2019, ICE announced its plans to launch IFAD, with the Abu Dhabi National Oil Company, or ADNOC, the producer of Murban crude and nine energy traders partnering with ICE on the launch. ICE Murban Crude Oil Futures will be a physically delivered contract with delivery at Fujairah in the United Arab Emirates, or UAE, on a free on board, or FOB, basis. ICE Murban Futures will be complemented with a range of cash settled derivatives. These include outright, differential and crack differentials against Brent, WTI, Gasoil and Naphtha among others, as well as inter-commodity spreads, which are planned to launch alongside Murban futures. Contracts traded at IFAD will be cleared at ICE Clear Europe, an energy clearing house, and will clear alongside ICE's global energy futures platform covering oil, natural gas and the environmental complex.