Stockwinners Market Radar for September 21, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:28 EDT GameStop up over 7% after RC Ventures increased activist stake to 9.98% - Shares of GameStop are up 7.1% afterhours at $9.37 per share after RC Ventures disclosed an increased stake of 9.98% vs. 9.0% reported on August 28th. The 13D/A filing indicates that "the Reporting Persons have had conversations and communications with senior management and several members of the Board of Directors of the Issuer concerning the Reporting Person's views of the company. During these conversations, the Reporting Persons expressed their willingness to become more involved in the company under certain circumstances that the Reporting Persons believe are likely to produce the best results for all shareholders."

18:35 EDT Coca-Cola CEO: We are going to follow the consumer - In an interview on CNBC's Mad Money, James Quincy said the company has always tried to be consumer-centric. He expects Coca-Cola to introduce hard seltzer in U.S in first half of 2021, noting it will be a "great opportunity" for the company. Quincy expects the company to significantly streamline its brand portfolio by the end of next year, taking out about half of its brands. Coke is powering growth, allowing the company to pursue new areas, he said.

18:09 EDT Aileron Therapeutics enters $15M common stock purchase with Lincoln Park Capital - Aileron Therapeutics announced it has entered into a common stock purchase agreement for up to $15M with Lincoln Park Capital Fund. In connection with the execution of the purchase agreement, LPC made an initial purchase of $500,000 of common stock at $1.36 per share. Thereafter, Aileron will have the option, but not the obligation, to sell to LPC up to an additional $14.5 million in shares of common stock over a thirty-six-month period subject to certain conditions, including a registration statement being filed and declared effective by the SEC.

17:46 EDT StoneCastle reports NAV $21.04 as of August 31 - The NAV was up 22c or approximately 1% as compared to the prior month-end.

17:43 EDT Blizzard says BlizzConline taking place Feb. 19-20, 2021 - Blizzard said that BlizzConline, an online version of its annual BlizzCon event, is set to take place February 19-20, 2021. The company tweeted, "There's lots of planning left to do, but we wanted to provide an early heads-up on how you can take part in the online festivities!" Reference Link

17:39 EDT Trian confirms 7.2M share stake in Comcast through June 30th - Following earlier report by The Wall Street Journal that activist fund Trian has amassed a $870M stake in Comcast with an acquisition of about 20M shares, the fund's 13F-HR/A filing released after-hours indicates that as of June 30th, Trian's stake in Comcast amounted to 7.16M shares.

17:17 EDT Fulgent Genetics to replace Garrett Motion in S&P 600 at open on 9/25 - Garrett Motion is filing for bankruptcy protection and is ineligible for continued inclusion the in S&P SmallCap 600.

17:05 EDT Nam Tai Property appoints Jiabiao Wang CEO, Lai Ling Tam executive chairman - Nam Tai Property announced that its board has appointed Lai Tam to the role of executive chairman of the board and has named Jiabiao Wang, current general manager of China operations, as CEO of Nam Tai. These appointments, which are effective immediately, follow the previously announced resignation of Ying Chi Kwok from the role of chairman and CEO. The company also announced, concurrently, the appointment of Wai Hang Wan as CFO, succeeding Yu Zhang, effective immediately. Wing Yan Lo, chairman of the compensation committee said, "The appointment of Dr. Tam as Executive Chairman brings to the Nam Tai Board a seasoned executive with a 25-year track record of success across the finance and real estate sectors, as well as valuable insights from a shareholder perspective. Dr. Tam's deep understanding of our industry and the markets in which we operate, coupled with his focus on supporting the interests of all Nam Tai shareholders, make him particularly well suited to lead the Board and shape the Company's strategic direction as we work to strengthen our position as a leading industrial ecosystem operator. The appointment of Mr. Wang as CEO reflects our focus on developing our deep pool of internal talent. A 15-year real estate industry veteran, Mr. Wang has significant real estate development, leasing and project management experience, with a proven track record of strong returns in both commercial and residential projects. As General Manager of our China operations, Mr. Wang has played a key role executing our development and leasing strategy, and has gained a deep understanding of the Company's business and operating model. He has proven to be an exceptional leader and is ideally suited to assume this role. We look forward to benefiting from Mr. Wang's experience and business acumen as we enter this exciting next chapter of growth under his leadership."

17:01 EDT TherapeuticsMD, Knight announces Health Canada approval of BIJUVA - Knight Therapeutics and TherapeuticsMD announced the approval of BIJUVA capsules by Health Canada. In Canada, BIJUVA is indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause in women with an intact uterus. VMS are commonly known as hot flashes or flushes and night sweats. VMS affect 60% to 80% of women entering menopause. BIJUVA is a once-daily combination of estradiol and progesterone in a single oral capsule that will be available in two strengths in Canada. The two hormones included in BIJUVA have the same structure as the hormones produced and circulating in the woman's body. In the U.S., BIJUVA is marketed by TherapeuticsMD and is indicated in a woman with a uterus for the treatment of moderate to severe vasomotor symptoms due to menopause. "We are pleased to be able to offer a new treatment for postmenopausal women to address challenging symptoms of hot flashes and night sweats with BIJUVA." said Samira Sakhia, President and Chief Operating Officer of Knight.

16:46 EDT Mid Penn Bancorp announces consolidation of three retail branches - Mid Penn Bancorp announced the planned consolidation of three branches in the Bank's retail network effective December 31, 2020. The consolidation, which affects its Malvern, Pillow, and Vanderbilt locations, is part of Mid Penn's strategy to optimize the delivery of banking services and in response to shifting consumer preferences. Customers will continue to have access to nearby branches as well as a robust set of technology-based services. The Bank expects no lay-offs or job losses as a result of this consolidation; employees at the impacted branches will continue to deliver best in class service at other locations in the region. The company anticipates annualized savings in excess of $150,000 and anticipates recouping the one-time costs associated with the initiative by the third quarter of 2021.

16:38 EDT Hallmark Financial CFO Jeff Passmore steps down - Hallmark Financial Services announces that on September 15, 2020, Jeff Passmore, CFO, submitted his resignation. Mr. Passmore will remain with the company through October 9, 2020, to facilitate an orderly transition. The company has commenced a search for a new CFO. In the interim, Christopher Kenney, SVP and Chief Accounting Officer, will serve as the company's principal financial officer.

16:36 EDT Synchronoss names Jeff Miller interim president, CEO - Synchronoss Technologies announced that its Board of Directors has appointed Jeff Miller as interim President and Chief Executive Officer, effective immediately, in addition to his role as Chief Commercial Officer. He succeeds Glenn Lurie who has resigned as the Company's President and Chief Executive Officer, and as a member of its Board of Directors, following the Board of Directors' review of allegations of personal misconduct by Mr. Lurie in violation of the Company's policies. His resignation is not related to the Company's strategy, financial or business performance. Given the expectation that all employees will respect Synchronoss' values and adhere to the Company's code of conduct, the Board has accepted Mr. Lurie's resignation. The Board of Directors will conduct an executive search to identify a permanent President and Chief Executive Officer. "Synchronoss continues to develop innovative technology and solutions for some of the world's leading technology and telecommunications companies," said Stephen Waldis, Founder and Chairman of the Board of Synchronoss. "The Board and I look forward to working with Jeff, our Chief Financial Officer David Clark and the broader Synchronoss management team to drive forward the ongoing transformation of Synchronoss, building on the strength of our customer relationships, and delivering long-term value to our shareholders. We anticipate a smooth leadership transition as we commence a robust search process for the Company's next CEO." In parallel, Synchronoss is maintaining its 2020 guidance on EBITDA of $20 million to $25 million, as previously communicated in its second quarter earnings release dated August 10, 2020. Additional details relating to the Company's financial performance and business outlook will be provided during its customary quarterly earnings call in November 2020.

16:31 EDT Domino's Pizza names Kelly Garcia EVP, Chief Technology Officer - Domino's Pizza announced the promotion of Senior Vice President - Chief Technology Officer Kelly Garcia to executive vice president - chief technology officer, effective Oct. 2. Garcia will join the company's senior leadership and will report to Domino's COO Russell Weiner. Garcia replaces Executive Vice President - Chief Information Officer Kevin Vasconi, who has announced his retirement from Domino's, effective Oct. 2.

16:23 EDT Ascena Retail announces plan of reorganization update - Ascena Retail and certain of its subsidiaries announced recent milestones achieved in the company's court-supervised restructuring process. The United States Bankruptcy Court for the Eastern District of Virginia has approved the adequacy of the company's disclosure statement filed in connection with the solicitation of votes on Ascena's plan of reorganization and the procedures to be used in connection with the solicitation of votes on the plan. With this approval, the company will commence solicitation of votes from its creditors for approval of the plan, which includes an amended restructuring support agreement that now has the support of approximately 95% of Ascena's secured term lenders and is expected to significantly reduce Ascena's debt by approximately $1B. The hearing to consider confirmation of the plan is currently scheduled to commence on October 23. The company has also received approval from the court on a final basis for Ascena's debtor-in-possession, or DIP, financing. The company's DIP financing comprises a $400M ABL facility and an approximately $312M term loan, which includes $150M in new money and will convert to exit financing upon the company's emergence from the Chapter 11 process. Upon final approval of the plan, and with approved DIP and exit financing, the company is on track to emerge from the Chapter 11 process with a stronger balance sheet and operating structure. Following a comprehensive sales process and auction conducted under Section 363 of the U.S. Bankruptcy Code, Ascena announced that FullBeauty Brands Operations will acquire Catherines' intellectual property assets for a base purchase price of $40.8M and potential upward adjustment for certain inventory. At closing, Ascena and FullBeauty expect to enter into a mutual transition services agreement in order to provide for a seamless transition of the e-commerce business. The TSA is expected to remain in effect for 30 days. The transaction is subject to court approval and certain other closing conditions. A hearing to seek court approval for the transaction is scheduled for September 21. The transaction is expected to close in the coming weeks. The company continues to operate its Ann Taylor, LOFT, Lane Bryant, Justice and Lou & Grey brands as normal through a reduced number of retail stores and online.

16:20 EDT RE/MAX Holdings acquires Gadberry Group, terms not disclosed - RE/MAX Holdings announced the acquisition of the Gadberry Group. Gadberry Group is a location intelligence data company whose products have been instrumental in the success of the newly launched www.remax.com consumer website. Founded in 2000, Gadberry Group's team is comprised of a total of 16 employees including engineers, data scientists and customer success experts who specialize in building best-in-class products that help clients solve geospatial challenges through accurate and precise location data. Gadberry Group will continue to serve non-RE/MAX clients while maintaining their contributions to the RE/MAX technology stack. No financial details concerning the Gadberry Group acquisition were disclosed. Consideration paid was comprised of cash and the company's stock. RE/MAX Holdings expects the acquisition of Gadberry Group to have a negligible impact to its third quarter financial results and to be accretive to adjusted EBITDA and adjusted EPS beginning in 2022.

16:13 EDT Capital Senior Living announces CFO Carey Hendrickson will step down - Capital Senior Living announced that Carey Hendrickson, Executive Vice President and Chief Financial Officer, will step down from his position to pursue another opportunity. To ensure a smooth transition, Mr. Hendrickson will remain in his current role through November 6, 2020. The Company has initiated a comprehensive search for a successor and has retained a leading executive search firm to assist with the process. "We thank Carey for his numerous contributions to the company during his tenure as CFO," said Kimberly S. Lody, President and Chief Executive Officer. "He has been a valued member of the team helping to lead Capital Senior Living through this dynamic time. We appreciate his support in ensuring a smooth transition, and wish him all the best going forward."

16:09 EDT Silk Road names Buchanan COO, appoints William Whealon EVP research - Silk Road Medical announced that it is strengthening its leadership team with two appointments. William Whealon, Ph.D. has joined the company as Executive Vice President of Research and Development, effective immediately. Silk Road Medical has also named Lucas Buchanan, the company's current Chief Financial Officer, to also serve as its Chief Operating Officer, effective October 1. "We are excited to welcome Bill to Silk Road Medical as we further strengthen our leadership team. His proven track record for building and leading effective and innovative R&D groups and his passion for identifying solutions to solve unmet clinical needs will be instrumental in our continued efforts to achieve durable growth," said Erica Rogers, President and Chief Executive Officer of Silk Road Medical. Dr. Whealon brings over two decades of scientific and development leadership to Silk Road Medical, where he is responsible for advancing pipeline programs and expanding the company's intellectual property portfolio. Prior to joining Silk Road Medical, Dr. Whealon served as Vice President of Research and Development for the Peripheral Vascular business at Medtronic where he was responsible for product development across three worldwide sites. Dr. Whealon received a B.S. degree in Metallugical Engineering and a Ph.D. in Materials Science and Engineering from the University of Wisconsin Madison. "Silk Road Medical has a unique opportunity to improve patient outcomes and create significant value for healthcare stakeholders by leveraging its intellectual property portfolio and culture of innovation. I am looking forward to leading the R&D team as we further capitalize on the potential of transcarotid technologies and therapies," said William Whealon, Ph.D., Vice President of Research and Development at Silk Road Medical. Mr. Buchanan, in his expanded role, will assume additional responsibility and leadership over key operations and administrative functions for the company, including strategic initiatives, operations, manufacturing and supply chain management. Ms. Rogers continued, "Lucas' deep knowledge of our business and strong leadership skills make him the ideal COO for Silk Road Medical as we continue to focus on operational excellence while we scale our business and pursue several strategic initiatives."

16:08 EDT ADC Therapeutics submits BLA to FDA for Loncastuximab in DLBCL - The company states: "ADC Therapeutics announced the submission of a Biologics License Application to the FDA for loncastuximab tesirine, or Lonca, for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma, or DLBCL. The BLA submission is based on data from LOTIS 2, the pivotal Phase 2 multi-center, open-label, single-arm clinical trial evaluating the efficacy and safety of Lonca in patients with relapsed or refractory DLBCL following greater than or equal to2 lines of prior systemic therapy. In June 2020, the company presented maturing data from LOTIS 2 at the virtual 25th Congress of the European Hematology Association. As of the April 6, 2020 data cut-off date, 145 patients were enrolled in the trial and patients had received a median of 3 prior lines of therapy. Lonca demonstrated an overall response rate of 48.3% and a complete response rate of 24.1%. The tolerability profile was generally manageable, with the most common grade greater than or equal to3 treatment-emergent adverse events in greater than or equal to10% of patients being: neutropenia with low incidence of febrile neutropenia, thrombocytopenia, GGT increased and anaemia."

16:05 EDT Fortune Brands announces $500M buyback - Fortune Brands announced that its board authorized the repurchase of up to $500M of shares of the company's common stock over the next two years on the open market or in privately negotiated transactions in accordance with applicable securities laws. The purchases, if made, will occur from time to time depending on market conditions.

14:58 EDT Ionis' treatment of Alexander disease granted FDA orphan designation - Ionis Pharmaceuticals' treatment of Alexander disease was granted FDA orphan designation, according to a post to the agency's website. Reference Link

14:16 EDT Sanofi says Libtayo reduced death risk by 32% compared to chemotherapy in trial - Pivotal trial data for the investigational use of PD-1 inhibitor Libtayo in first-line locally advanced or metastatic non-small cell lung cancer, or NSCLC, were shared in a presentation at the European Society for Medical Oncology, or ESMO, Virtual Congress 2020, Sanofi announced. The trial compared Libtayo monotherapy to platinum-doublet chemotherapy in patients whose tumor cells expressed PD-L1, including those whose cancers had confirmed PD-L1 expression of greater than or equal to 50%. These results form the basis of regulatory submissions, including in the U.S. and European Union. The late-breaking ESMO presentation expands on topline results shared in April. In the overall trial population of 710 patients, the median follow-up was 13 months for both Libtayo and chemotherapy. Among these patients, Libtayo demonstrated the following results compared to chemotherapy: 32% reduced risk of death; 22-month median overall survival compared to 14 months; 41% reduced risk of disease progression; and 37% objective response rate. Reference Link

12:48 EDT Sasol provides update on Lake Charles chemical complex - Sasol said in a statement: "Hurricane Laura made landfall on 27 August 2020 near Sasol's Lake Charles Chemical Complex in Southwest Louisiana, and is one of the strongest hurricanes on record to hit the United States. Significant property and utility infrastructure damage has been experienced across the region. Sasol's more than 800 Lake Charles employees are safe; however, hundreds of employees have suffered significant damage to their homes and remain in temporary housing while utility restoration and repair work is in progress. Sasol is assisting employees with home preservation, essential supplies and financial aid. In addition Sasol is supporting the local authorities, utility partners and citizen groups in community and infrastructure recovery efforts. Sasol has completed damage assessments of the complex's 14 manufacturing facilities and associated utilities and infrastructure. While there was moderate wind damage to cooling towers and some insulation and building damage, there is no apparent damage to major process equipment, utilities or infrastructure. This will need to be confirmed once site electrical power is completely restored and all systems are tested. Removal of debris, repair work and startup planning continue on the site. Regular employee work shifts have resumed, and several hundred contractors are working on site to expedite readiness for startup. The Sasol Lake Charles site is currently partially energized. Entergy expects full load service, industrial-level reliability power, to be available to Sasol and other industrial customers in the area by early-to-mid October."

12:35 EDT Bristol-Myers announces primary results from CheckMate -649 trial - Bristol Myers Squibb announced primary results from CheckMate -649, the pivotal Phase 3 trial in which first-line treatment with Opdivo plus chemotherapy showed "a statistically significant and clinically meaningful improvement" in the overall survival and progression-free survival of patients with unresectable advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma compared to treatment with chemotherapy alone. "Opdivo is the first PD-1 inhibitor to demonstrate superior OS and PFS in combination with chemotherapy when compared to chemotherapy alone in patients with gastric cancer, GEJ cancer or esophageal adenocarcinoma," the company stated. The OS and PFS benefits were observed in patients whose tumors express PD-L1 with a combined positive score greater than or equal to 5, achieving both of the trial's primary endpoints. The OS benefit was also observed in the all-randomized trial population. CheckMate -649 is the largest randomized, global Phase 3 study of an immune checkpoint inhibitor-based therapy in the first-line setting for patients with gastric and esophageal cancers conducted to date, the company stated. "CheckMate -649 recently became the first global study in over a decade to demonstrate a significant overall survival benefit over chemotherapy in the first-line setting of non-HER2 positive gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma, highlighting the potential of Opdivo plus chemotherapy to become a new standard of care for these patients, regardless of their tumor location. These available results of the CheckMate -649 study will be discussed with global health authorities as we strive to bring this important new treatment option to patients in need," said Ian M. Waxman, M.D., development lead, Gastrointestinal Cancers, Bristol Myers Squibb.

12:20 EDT Thoma Bravo completes acquisition of Majesco - Thoma Bravo announced that it has completed the acquisition of Majesco. As previously announced on August 8, under the terms of an amended and restated definitive merger agreement, Thoma Bravo agreed to acquire all of the issued and outstanding shares of Majesco common stock for $16.00 per share in cash. In conjunction with the closing, Majesco's common stock will cease trading before the market opens on Tuesday, September 22 and the company will no longer be listed on the Nasdaq stock exchange. Majesco will operate as a privately-held company.

12:02 EDT KLA Corp. appoints MaryBeth Wilkinson as EVP, chief legal officer - KLA Corporation announced the appointment of MaryBeth Wilkinson as executive vice president, chief legal officer and corporate secretary. Based in KLA's second headquarters in Ann Arbor, Michigan, Wilkinson will lead the company's legal and compliance organization, providing legal counsel to executive management and the board of directors. "A highly-regarded, welcome addition to our organization, we are confident MaryBeth will help drive, support and enrich KLA's rapid expansion and business growth," said Rick Wallace, KLA president and CEO. Directing all legal affairs of the organization, Wilkinson will be responsible for corporate governance, policy and regulatory strategy development, litigation oversight, environmental matters, intellectual property, global corporate compliance, and labor and employment laws. Wilkinson will report directly to Wallace.

12:00 EDT Daily S&P Biotech Bear 3x Shares rises 11.7% - Daily S&P Biotech Bear 3x Shares is up 11.7%, or $6.23 to $59.64.

12:00 EDT Cubic rises 27.8% - Cubic is up 27.8%, or $12.33 to $56.70.

11:19 EDT Elliott Management says 'fully prepared to acquire Cubic' - Elliott Management Corporation, which manages funds that own a significant economic interest in Cubic Corporation, released the following statement from Elliott Partner Jesse Cohn and Portfolio Manager Marc Steinberg regarding Cubic's shareholder rights plan announcement: "Over the past several weeks, Elliott has engaged privately with Cubic regarding a potential acquisition of the company. In response to the company's decision to make our dialogue public, we can confirm that we have acquired an approximately 15% economic interest in the company and have partnered with a leading private equity firm to pursue this opportunity. While we are disappointed with the board's decision to impose a shareholder rights plan, we are pleased that the board has acknowledged its fiduciary duty to engage in good faith in pursuit of the value-maximizing outcome for Cubic and our fellow shareholders. We are fully prepared to acquire Cubic and look forward to immediate engagement with the company."

11:15 EDT PagerDuty announces new integration with Zoom Video - PagerDuty (PD) announced a new integration with Zoom Video Communications (ZM) that it said enables DigitalOps teams to "quickly initiate Zoom meetings from within the PagerDuty platform, in one click." PagerDuty stated in its press release on the partnership: "With the whole world relying on digital services to live, work, learn and connect, it's critical for organizations to be able to orchestrate remote team work to resolve problems fast, no matter where employees are and using the collaboration tools of their choice. With the new Zoom and PagerDuty integration anyone in the incident response team can assemble people in the moment, or via a prescribed runbook response, without having to set up formal meetings and send invitations via email and chat." Oded Gal, Chief Product Officer of Zoom, added: "Zoom has become an essential part of everyday work, it's only natural that it be further automated through PagerDuty, so that people can immediately address issues in the moment."

11:02 EDT CapStar Financial appoints Denis Duncan as CFO - CapStar Financial Holdings and CapStar Bank announced that, due to an unexpected family health matter, Mike Fowler has requested to step down as CFO and assume the position of Treasurer. Accordingly, CapStar announces that Denis Duncan has been appointed CFO, effective September 21. Duncan recently retired from PricewaterhouseCoopers, where he was a senior banking and capital markets partner.

10:40 EDT Airbus announces concept design for zero-emission concept aircraft - Airbus has revealed three concepts for the world's first zero-emission commercial aircraft which could enter service by 2035. These concepts each represent a different approach to achieving zero-emission flight, exploring various technology pathways and aerodynamic configurations in order to support the Company's ambition of leading the way in the decarbonisation of the entire aviation industry. All of these concepts rely on hydrogen as a primary power source - an option which Airbus believes holds exceptional promise as a clean aviation fuel and is likely to be a solution for aerospace and many other industries to meet their climate-neutral targets. The three concepts - all codenamed "ZEROe" - for a first climate neutral zero-emission commercial aircraft include: A turbofan design with a range of 2,000+ nautical miles, capable of operating transcontinentally and powered by a modified gas-turbine engine running on hydrogen, rather than jet fuel, through combustion. The liquid hydrogen will be stored and distributed via tanks located behind the rear pressure bulkhead. A turboprop design using a turboprop engine instead of a turbofan and also powered by hydrogen combustion in modified gas-turbine engines, which would be capable of traveling more than 1,000 nautical miles, making it a perfect option for short-haul trips. A "blended-wing body" design concept in which the wings merge with the main body of the aircraft with a range similar to that of the turbofan concept. The exceptionally wide fuselage opens up multiple options for hydrogen storage and distribution, and for cabin layout.

10:32 EDT Facebook introduces Rights Manager for Images tool - In a post, Dave Axelgard, Facebook, product manager, creator and publisher experience, said, "We want to ensure Facebook is a safe and valuable place for creators to share their content. That's why we built tools like Rights Manager in Creator Studio to help creators and publishers who have a large or growing catalog of content better control when, how and where their content is shared across Facebook and Instagram. Today, we are introducing Rights Manager for Images, a new version of Rights Manager that uses image matching technology to help creators and publishers protect and manage their image content at scale. To access Rights Manager, Page admins can submit an application for content they've created and want to protect. Rights Manager will find matching content on Facebook and Instagram. Settings can be adjusted to match things like ownership that should apply worldwide or only in certain locations. In addition to the free content management tools we offer to help combat infringement, we also have a fast and effective IP reporting system, a repeat infringer policy and other measures. And protecting intellectual property is an important part of our Terms of Service. Learn more about copyright protections offered on Facebook."

10:23 EDT Exelixis announces results from two cohorts of COSMIC-021 trial - Exelixis announced "positive" phase 1b clinical trial results for the combination of cabozantinib and atezolizumab in patients with locally advanced or metastatic solid tumors. Data from two expansion cohorts of the COSMIC-021 trial was presented during the European Society for Medical Oncology, or ESMO, Virtual Congress 2020. Results from the clear cell renal cell carcinoma cohort are being presented in the GU Proffered Paper Session on September 21, and results from the non-clear cell RCC cohort were presented as a poster available on demand for registrants beginning September 17, the company noted. "Given the broad experience with cabozantinib as monotherapy for advanced kidney cancer, it's very exciting to see the growing body of clinical evidence that demonstrates encouraging tolerability and clinical activity when combining cabozantinib with atezolizumab in this disease. We are especially encouraged to see a durable objective response in more than 50% of patients with previously untreated clear cell RCC, paired with an acceptable safety profile at both cabozantinib dose levels evaluated in combination with atezolizumab. We look forward to learning more about the potential of this combination regimen to improve outcomes for patients with advanced kidney cancer from the ongoing phase 3 CONTACT-03 trial," said Dr. Sumanta Pal, Clinical Professor, City of Hope, the principal investigator for the COSMIC-021 study.

10:04 EDT Air Products announces NA price increase for liquid, industrial gas products - Effective October 1, 2020, or as contracts permit, Air Products will increase product pricing, monthly service charges, and surcharges for merchant customers in North America. These adjustments include increases of: Up to 15% for liquid nitrogen and liquid oxygen; Up to 15% for liquid carbon dioxide; Up to 20% for monthly service charges. Some adjustments may be outside of these ranges based on specific situations. Helium, hydrogen and argon prices will also be increased based on supply/demand and cost situations and may be customer specific. These adjustments are in response to increases in sourcing, production and delivery costs, and support continued investments in reliability, security, and safety.

10:01 EDT Misonix enters supply, distribution agreement with Gunze Limited - Misonix announced that it has entered into an exclusive supply and distribution agreement with Gunze Limited for TheraGenesis Bilayer Wound Matrix. TheraGenesis is a proprietary, FDA cleared, porcine tendon derived collagen wound matrix with a silicone film layer used to treat trauma, burn and reconstructive wounds.

10:00 EDT Small Cap Bear 3x rises 9.4% - Small Cap Bear 3x is up 9.4%, or $1.54 to $17.84.

09:58 EDT Amwell says Teladoc patent infringement claims 'lack merit' - Amwell (AMWL) disclosed last week that on September 14, it received a letter from Teladoc Health (TDOC) alleging that certain of its cart products and associated peripherals infringe upon their patents. "While we can provide no guarantees about the outcome of any potential dispute, we believe that these claims lack merit and, if Teladoc attempts to bring these claims to court, we intend to defend against them vigorously," Amwell said in a regulatory filing . "Moreover, even if we were found to infringe upon any valid claim of these patents, our revenues from the Carepoints products approximated 5% of our revenues in 2019," it added.

09:47 EDT Small Cap Bear 3x rises 6.2% - Small Cap Bear 3x is up 6.2%, or $1.01 to $17.31.

09:47 EDT Cubic rises 14.2% - Cubic is up 14.2%, or $6.31 to $50.68.

09:39 EDT CleanSpark commissions software on new microgrid featuring Tesla batteries - CleanSpark (CLSK) announced the commissioning of its software on a new solar plus storage microgrid project in Central America. CleanSpark is partnered with an energy developer to deploy this unique solution for Micro Technologies SA, a major international assembly and manufacturing company. This microgrid is for their new factory located in the San Jose, Alajuela Province of Costa Rica. The local clean-energy developer focuses on distributed power generation, storage, and management. They have installed some of the first microgrids in Latin America. This collaborative project between the two companies will incorporate grid-tied solar and energy storage systems primarily to offset utility energy costs. The secondary function of the system is to provide backup power during utility outages from construction through commissioning of the complex, as well as when facility is fully operational. CleanSpark is providing its patented mPulse controls with market-based forecasting and operation. The company has also procured and will incorporate the Tesla (TSLA) PowerPack 2 battery energy storage system which will provide 558kW/1115kWh storage. Additionally, the project's solar installation includes 480kW AC, 531kW DC of PV solar panels. This represents the second microgrid located in Costa Rica with an mPulse controller paired with a Tesla energy storage solution.

09:27 EDT PagerDuty to acquire Rundeck for approximately $100M - PagerDuty announced that it has entered into a definitive agreement to acquire Rundeck, a leading provider of DevOps automation for enterprise. to acquire Rundeck for enterprise. The acquisition strengthens PagerDuty's leading incident response offering with intelligent machine automation including auto-remediation and self-healing that bring increased productivity to resolution and recovery efforts. Under the terms of the definitive agreement, PagerDuty will acquire Rundeck for a total purchase price of approximately $100M subject to adjustment, to be paid approximately 60% in cash and 40% in PagerDuty common stock. The acquisition is subject to certain customary closing conditions and is expected to close in October 2020.

09:18 EDT Ampio: FDA grants IND, approves trial protocol of inhaled Ampion - Ampio Pharmaceuticals announces the receipt of an Investigational New Drug from the U.S. FDA, allowing the company to proceed with clinical trials for the use of Ampion as an inhalation therapy for respiratory distress due to COVID-19 infection.

09:16 EDT Euroseas announces charter for C/V Akinada Bridge, sale of C/V Ninos - Euroseas announced its container vessel, C/V "Akinada Bridge", with capacity of about 5,600 teu and built in 2001, has extended her time charter contract for a minimum duration of twelve months and maximum duration of thirteen months and an additional ten to twelve months in charterers option, at a daily rate of $17,250 and $20,000 respectively. The new rate will commence on October 30th 2020. Furthermore, the charterers of C/V Synergy Oakland have declared their option to extend her charter for another 8-12 months at a rate that is determined by the Contex-4,250 Index less 10%. This rate will be applied starting October 23rd, 2020. As of 9/17/2020 the Contex-4,250 index stands at $15,369 and is subject to change every Tuesday and Thursday each week. In addition to the above, the company signed an agreement to sell C/V Ninos, a 1,169 teu vessel, built in 1990 for scrap for approximately $2.36m gross. The vessel is expected to be delivered to the buyer prior to September end.

09:15 EDT VivoPower announces non-binding LOI to acquire 51% shareholding in Tembo - VivoPower International announced that it has signed a non-binding Letter of Intent to acquire a 51% shareholding in Tembo 4x4 e-LV, a specialist battery-electric and off-road vehicle company with customers globally in the mining, government services, game safari and humanitarian aid sectors. The purchase consideration will be $4.7M and VivoPower will have the option to acquire the remaining 49% of Tembo in the future. Founded in the Netherlands, Tembo has since grown its global sales and distribution channels across four continents, with current customers in Australia, Africa, Europe, and North America. For its fiscal year ended December 31, 2019, Tembo generated $2.3M in revenue and an EBITDA loss of $0.2M, derived from battery-electric and off-road vehicle solutions. The Company is conducting due diligence and is in process of negotiating definitive documents with Tembo. The Company anticipates entering into a definitive agreement with Tembo and plans to disclose the terms of such definitive agreement when and if executed. The Company is working to close the transaction as promptly as practicable, subject to finalizing confirmatory tax, legal and accounting due diligence.

09:13 EDT Gevo welcomes targeted increased use of SAF by Sweden, Norway - Gevo welcomed two announcements from the Scandinavian region regarding Sustainable Aviation Fuel. As part of Sweden's target to be fossil-free by 2040, the Swedish Government announced on September 11th its intention to introduce a greenhouse gas reduction mandate for aviation fuel. The reduction level is expected to be 0.8% in 2021 and gradually increase to 27% by 2030, with most of the savings expected to come from the use of SAF. In addition to Sweden's announcement, Norway announced earlier this year to introduce a 0.5% biofuel blending mandate. Norway's ultimate target is for a 30% share of biofuels in the aviation sector by 2030. For every gallon of SAF produced, Gevo also produces approximately 10 pounds of protein that goes into the food supply chain and can sequester up to 2 pounds of carbon dioxide as carbon into the soil, making it one of the only renewable jet fuel producers to produce both food and fuel while sequestering carbon dioxide and lowering the GHG emissions as compared to traditional fossil-based jet fuel. In addition to adding food back into the food chain, Gevo will also be more transparent with its sustainability practices by utilizing blockchain technology to track its sustainable agriculture efforts. In April 2016, ASTM International completed its process of approving a revision of ASTM D7566 to include alcohol to jet synthetic paraffinic kerosene derived from renewable isobutanol. This allows Gevo's SAF to be used as a blending component in standard Jet A-1 fuel for commercial airline use in the U.S. and around the globe.

09:13 EDT Easterly Government Properties acquires FBI field office in Alabama - Easterly Government Properties announced that it has acquired a 76,112-square foot Federal Bureau of Investigation, or FBI, field office in Mobile, Alabama. FBI - Mobile is a three-story office building and single-story vehicle maintenance facility located on a roughly four-acre site that houses the FBI's Mobile field office, which oversees federal operations over 36 counties through five satellite offices in Auburn, Dothan, Monroeville, Montgomery and Selma. This build-to-suit property was completed in 2001 and is 100% leased to the General Services Administration for the beneficial use of the FBI until December 2029.

09:12 EDT AngioDynamics launches Auryon Atherectomy Sytem - AngioDynamics announced the launch of the Auryon Atherectomy System, a newly-developed technology for the treatment of Peripheral Artery Disease, or PAD,including Critical Limb Ischemia, or CLI and In-Stent Restenosis, or ISR. The Auryon Atherectomy System uses technology to deliver treatment of PAD lesions and occlusions.

09:10 EDT China Ceramics regains Nasdaq compliance - China Ceramics announced that it has received a letter from the Listings Qualifications Department of The Nasdaq Stock Market notifying the company that it has regained compliance with NASDAQ's minimum bid requirements for continued listing requirements on the NASDAQ Stock Market. On September 3, the company effected a one-for-three reverse stock split to regain compliance with the minimum bid price requirement of $1.00 per share for continued listing on the NASDAQ Stock Market. The letter noted that since the closing bid of the company's common stock has been $1.00 per share or more for 10 consecutive business days, from September 3 to September 18, the company has regained compliance with Nasdaq Listing Rule 5550(a)(2) and that the matter is now closed.

09:10 EDT 4-CT, United Way of Central and Northeastern Connecticut select USIO - Usio announced that 4-CT and United Way of Central and Northeastern Connecticut have selected Usio's proprietary prepaid card-issuing platform as its preferred channel to distribute relief funds to those in need as a result of the COVID-19 pandemic. 4-CT and UWCNC are the latest in a growing list of governmental and non-profit organizations that recognize Usio's prepaid card platform is a convenient, flexible and more efficient means to manage charitable programs.

09:09 EDT Peacock now available on Roku platform - Peacock and Roku announced the Peacock app is now available nationwide on the Roku platform, reaching households with an estimated 100M people. Peacock provides access to more than 20,000 hours of on-demand movies and shows, as well as live news and sports programming, from NBCUniversal and beyond. Peacock uniquely offers the only free tier of premium content in the market, featuring more than 13,000 hours of current, classic, and original movies and shows, as well as timely live and on-demand content across news, sports, reality, late-night, and Spanish-language.

09:07 EDT Kubient, Zoox Smart Data launch strategic partnership - Kubient and Zoox Smart Data have launched a strategic partnership to allow advertisers to buy with vetted first party, consumer provided audience data, resulting in more efficient spends and maximum value connecting with premium audiences. This is the first adtech infrastructure and marketplace partnership that enables real time bidding programmatic access to and from demand platforms, brands and agencies. The close strategic partnership will grow an existing audience of over 100M Wi-Fi users a year, to almost to a billion users in the next 18 months.

09:06 EDT MPLX announces binding open season - MPLX launched a binding open season to assess shipper interest in firm priority capacity on the SLC Core Pipeline System, located in Wyoming, to transport crude oil from Fort Laramie Station, Wyoming, to Wahsatch Station, Utah. From Wahsatch Station, crude transportation service is available on a third-party system for ultimate delivery to refineries in the Salt Lake City, Utah, area. The binding open season will commence on Sept. 21 and will end at noon CDT on Oct. 23.

09:05 EDT Taronis Fuels expands wholesale gas operations in Northern California - Taronis Fuels announced the expansion of its existing wholesale industrial gas operations into the Northern California market. This is the second significant geographic expansion of this business segment in the past two months. The Company acquired a large, regional industrial gas wholesale distributor in May of 2020. This distributor historically operated primarily in the Atlanta, Dallas, Orlando and Tampa metropolitan markets. In late August, the Company expanded this business into the Houston market, adding $1 million in new sales. On October 1st, the Company will launch its newest operations, serving the Sacramento, San Jose, San Francisco and Oakland markets. This geographic expansion represents the largest single organic expansion initiative in Taronis Fuel's history. Historically, the Company has driven most of its rapid growth through acquisitions. Due to the accelerated pace of these acquisitions, organic growth was a relatively small component of the Company's overall growth. With the acquisition of TGS in May, the Company has now shifted to a more balanced emphasis on leveraging its existing scale, depth of management and access to proprietary renewable fuel products to drive organic revenue growth. This expansion in Northern California is expected to add approximately $2M annually in highly profitable industrial gas sales, representing a 25% increase in sales for this business segment. When the $1M in new business from Houston is included, the Company will have already grown its wholesale industrial gas segment 38% on an annualized basis in less than four months. As previously disclosed, the Company has identified more than twenty new markets for expansion of the wholesale industrial gas business, which is a 100% organic growth driver for the Company.

09:04 EDT Abbott receives CE Mark for next-generation MitraClip device - Abbott announced it has received CE Mark for its fourth-generation MitraClip Transcatheter Mitral Valve Repair System, the leading minimally invasive mitral valve repair device in the world. Known as MitraClip G4, the device is now approved for use in Europe and other countries that recognize CE Mark as a non-surgical option for the treatment of mitral regurgitation (MR), or a leaky heart valve. The device is already approved for use in the U.S.

09:02 EDT Microsoft plans to acquire ZeniMax Media for $7.5B in cash - Microsoft announced plans to acquire ZeniMax Media, the parent company of Bethesda Softworks, one of the largest, privately held game developers and publishers in the world. Creators of critically acclaimed and best-selling gaming franchises including The Elder Scrolls and Fallout among many others, Bethesda brings an impressive portfolio of games, technology, talent, as well as a track record of blockbuster commercial success, to Xbox. Under the terms of the agreement, Microsoft will acquire ZeniMax Media for $7.5B in cash. The transaction is subject to customary closing conditions and completion of regulatory review. Microsoft expects the acquisition to close in the second half of fiscal year 2021 and to have minimal impact to non-GAAP operating income in fiscal years 2021 and 2022. Non-GAAP excludes the expected impact of purchase accounting adjustments, as well as integration and transaction-related expenses.

09:01 EDT Microsoft to acquire ZeniMax Media for $7.5B in cash

08:52 EDT JBG Smith Properties awarded CBRS spectrum in national landing through auction - JBG Smith announced that it has acquired seven blocks of Citizens Broadband Radio Service, CBRS, spectrum stretching across Arlington County and the City of Alexandria through a national FCC auction that concluded in late August. JBG Smith's investment in CBRS spectrum is part of a broader effort to develop National Landing into a world-class innovation district. The acquisition of spectrum accelerates JBG SMITH's ability to partner with leading service providers to bring 5G and other technology infrastructure to National Landing. JBG SMITH envisions the area as a canvas for innovation in industry clusters such as defense and cybersecurity, cloud/edge computing, internet of things, and artificial intelligence. This robust technology infrastructure will allow enterprises to connect everything and everyone in real time and transform customer engagement and experiences in National Landing. JBG SMITH acquired four Priority Access Licenses totaling 40 MHz in Arlington (the maximum allowed in one jurisdiction for a single entity) and three PALs in Alexandria. A JBG SMITH subsidiary, SEAD LLC, purchased the seven licenses for $25.3 million. The licenses will span over 16.2 million square feet in National Landing and Potomac Yard, where JBG SMITH is the largest holder of existing and developable real estate. The submarket is also home to Amazon HQ2, the Virginia Tech Innovation Campus, and a diverse array of offices, apartments, retail, and open space. Matt Kelly, CEO, added, "We pursued ownership in spectrum to accelerate the roll-out of a ubiquitous 5G network in National Landing. We are eager to attract best-in-class service providers, so that our customers - the people that live, work, and play in National Landing - have the connectivity tools needed to innovate in an increasingly digital and flexible post-COVID economy."

08:48 EDT Cubic adopts shareholder rights plan in response to Elliott's takeover interest - Shares of Cubic Corporation (CUB) are sharply higher in pre-market trading after the company announced earlier that on September 20, its board of directors approved the adoption of a limited-duration shareholder rights plan and declared a distribution of one right for each outstanding share of common stock. The rights plan is effective immediately and will expire on September 19, 2021. The record date for the rights distribution is October 1, 2020. The Cubic board adopted the rights plan in response to Elliott Management informing the company privately that it has acquired a direct ownership and derivatives position that provided economic exposure equivalent to approximately 15% of Cubic's outstanding stock. Elliott further informed the company that it, and a private equity firm with whom Elliott has partnered, is interested in acquiring Cubic, subject to various conditions. "The Cubic board has not initiated a process to sell the company. The board believes that the company's standalone prospects are excellent and that Cubic's current strategic plan, including the recently announced NextCubic initiative, will create significant value for all Cubic shareholders," the company stated. "Cubic's Board is committed to creating long-term value and ensuring that our shareholders are able to realize the full potential of their investment in the Company," said David F. Melcher, Lead Independent Director of Cubic. "The adoption of the Rights Plan is intended to provide the Board with time to make informed decisions and prevent any third party from obtaining control of Cubic in a manner and at a price that are not in the best interests of Cubic's shareholders." The rights plan does not deter any offer or preclude the Cubic board from considering an offer that is fair and otherwise in the best interests of Cubic shareholders. Consistent with its duties, the board has and will review any proposal to significantly increase shareholder value, Cubic said. The rights will be exercisable only if a person or group acquires beneficial ownership - including certain synthetic equity positions created by derivative securities - of 15%, or 20% for passive institutional investors, or more of Cubic's outstanding common stock. Any shareholders with beneficial ownership of 15% or more of Cubic's outstanding common stock as of the time of this announcement are generally grandfathered at their current ownership levels but are not permitted to increase their ownership without triggering the rights plan. In pre-market trading, Cubic shares are up $6.33, or 14.3%, to $50.70.

08:47 EDT Hancock Jaffe Laboratories announces positive Nasdaq listing determination - Hancock Jaffe Laboratories announced that the company has received formal notification that the Nasdaq Hearings Panel has granted the Company's request for continued listing on The Nasdaq Capital Market pursuant to an extension through December 28, to evidence compliance with the minimum $1.00 bid price requirement. To evidence compliance with the rule, the Company must evidence a closing bid price of at least $1.00 per share for a minimum of ten, but generally not more than 20, consecutive business days by December 28. The extension constitutes the full extent of the Panel's discretion in this matter. The Company is taking definitive steps to timely evidence compliance with the terms of the Panel's decision and will provide an update regarding its compliance efforts when available. About Hancock Jaffe Laboratories specializes in developing and manufacturing bioprosthetic medical devices to establish improved standards of care for treating cardiac and vascular diseases. HJLI currently has two lead product candidates: the VenoValveÒ, a porcine based valve which is intended to be surgically implanted in the deep venous system of the leg to treat reflux associated with Chronic Venous Insufficiency; and the CoreoGraftÒ, a bovine tissue based off the shelf conduit intended to be used for coronary artery bypass surgery.

08:45 EDT Marimed granted approval to open third adult use dispensary in Illinois - MariMed announced it received an adult use license from the Illinois Department of Financial and Professional Regulation for its third adult use dispensary in Illinois. The dispensary is in Mount Vernon, IL, and will be operated under the Thrive brand, open for business on September 21, 2020 with a grand opening ceremony on September 25, 2020. Located in a newly remodeled 5,000-square foot building in a major retail area at the crossing of interstate highways US 64 and US 57, Thrive Mt. Vernon will market adult use cannabis and cannabis products in a previously underserved area. The location provides easy access to customers 21 years and older in the region as well as to those traveling into Illinois from Indiana, Kentucky, Tennessee, and Missouri. The dispensary will offer a variety of cannabis products from flower, topicals, edibles and concentrates, across multiple brands and product sizes, flavors, and other options, sourced from a majority of the 21 cultivators in the state. Consumers will also have access to a large selection of ancillary products. Additionally, the dispensary will feature an education and training area where interested qualified customers may learn about the attributes of cannabis usage, the technologies involved in cultivation and production, and career opportunities in this emerging industry. MariMed plans to open a fourth dispensary for adult use sales in 2021, pending all necessary licensing approvals.

08:41 EDT Greenlane names Michael Cellucci president, sales and marketing, North America - Greenlane Holdingss announced that it has hired Michael Cellucci as President of Sales and Marketing North America. In addition, Michael Ouwendijk will join Greenlane Europe as Sales & Marketing Director. As President of Sales and Marketing North America, Cellucci will oversee corporate vision as the organization continues to pursue higher-margin revenue opportunities. Cellucci served as President of Drew Estate: The Rebirth of Cigars Across Europe, Ouwendijk will be responsible for leading Greenlane's go-to-market strategies and consumer marketing and engagement. Ouwendijk has a proven track record of improving sales and marketing activities and expanding market share. Prior to Greenlane, he was Country Manager for Northern Europe at ST Dupont.

08:38 EDT Exagen launches test to aid in detection of ANCA-Associated Vasculitis - Exagen announced the launch of AVISE Vasculitis AAV, a new testing panel of individual analytes designed to provide physicians with rapid and reliable results in the assessment and monitoring of ANCA-associated vasculitis. ANCA-associated vasculitis is a group of autoimmune diseases characterized by vascular inflammation and damage. Early signs and symptoms vary greatly and are not always indicative of the severity of the disease. Rapid and accurate testing is essential to prevent death and long-term disability. AVISE Vasculitis AAV is intended for use in patients suspected of ANCA-associated vasculitis, otherwise recognized as small vessel diseases: granulomatosis with polyangiitis, microscopic polyangiitis, and eosinophilic granulomatosis with polyangiitis. AVISE Vasculitis AAV enhances Exagen's catalogue of AVISE tests, allowing physicians further access to Exagen's specialty lab dedicated to autoimmune diseases.

08:36 EDT China Pharma obtains multiple certifications for masks - China Pharma announced that the masks produced by its subsidiary Hainan Helpson Medicine & Biotechniqe Co., Ltd. has received multiple certifications, and have been listed on the Whitelist.

08:33 EDT Amyris' Pipette brand selected by Alibaba for entry into China market - Amyris (AMRS) announced that its Pipette baby and mother care brand was among a limited number of small- and medium-sized U.S. brands that were selected as a winner of Alibaba Group's Tmall Global Go Global 11.11 Pitch Fest. As a result, Pipette will be fast-tracked to enter the China market and launch on Alibaba Tmall Global's Singles' Day on November 11.

08:32 EDT Wrap Technologies says BolaWrap safely restrains suicidal subject in Florida - Wrap Technologies reported a successful deployment of the BolaWrap by St. Cloud Police Department in Florida. The encounter was captured on an officer's body-worn camera. According to the St. Cloud Police Department, on September 12, 2020, St. Cloud Police Department officers responded to a call in reference to an adult male apparently suffering with a mental health crisis. Information provided to the responding officers was that the subject wanted to commit "suicide by cop." Officers located the subject who was standing with his mother and brother in the driveway of a nearby residence. The subject's family advised responding officers that the subject had recently dealt with a relationship breakup that caused him to disdain law enforcement. The subject's mother also informed police officers that he wanted to be killed by law enforcement. The responding officers worked to de-escalate the situation by attempting to engage him in dialogue. It was obvious to the officers that he was distraught, mentally unstable and uncooperative. The officers implemented a tactical plan to restrict the subject's mobility through the use of the BolaWrap Remote Restraint device and deployed the BolaWrap around the subject's legs. As evident by the body camera footage, the deployment surprised and distracted the subject, allowing the officers the tactical advantage to safely approach the subject without injuring him or themselves. The subject was then transported to a mental health facility for evaluation.

08:30 EDT Keytruda doubled survival rate versus chemo in certain patients NSLC - Merc announced five-year survival results from the pivotal Phase 3 KEYNOTE-024 trial, which demonstrated a sustained, long-term survival benefit and durable responses with KEYTRUDA, Merck's anti-PD-1 therapy, versus chemotherapy as first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 . At five years, the overall survival rate was twice as high for patients who received KEYTRUDA versus chemotherapy. KEYTRUDA also reduced the risk of death by 38% (HR=0.62 [95% CI, 0.48-0.81) versus chemotherapy, with a median OS of 26.3 versus 13.4 months. Results from KEYNOTE-024 represent the longest follow-up and first-ever five-year survival data for an immunotherapy in a randomized Phase 3 study for the first-line treatment of NSCLC. "Before 2014, the five-year survival rate for patients in the U.S. with advanced non-small cell lung cancer was only 5%. Data presented today from KEYNOTE-024 showed that 31.9% of patients treated with KEYTRUDA were alive at five years," said Martin Reck, M.D., Ph.D., Lung Clinic Grosshansdorf, German Center of Lung Research. "Survival outcomes in these patients with metastatic lung cancer did not seem possible to many oncologists, including myself, several years ago. The long-term survival benefit achieved with KEYTRUDA as a single agent in this study is a great example of the progress we have made in lung cancer to provide patients with more time without disease progression and a chance at a longer life." "KEYTRUDA has become foundational in the treatment of metastatic lung cancer based on the sustained, long-term survival benefit demonstrated in our clinical trials. These new, first-of-their-kind five-year survival results from KEYNOTE-024 add to our understanding of the important role that KEYTRUDA now has in the treatment of lung cancer," said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. "It is particularly noteworthy that at five years, 81.4% of patients who completed two years of treatment with KEYTRUDA were alive and nearly half of these patients remained treatment-free, representing an encouraging new precedent in the first-line metastatic non-small cell lung cancer setting. We are grateful to the many patients and health care providers in this trial and our other trials for their essential role in these studies and in advancing cancer care."

08:28 EDT Tracon Pharmaceuticals highlights updated clinical data from envafolimab trial - TRACON Pharmaceuticals highlighted updated clinical data from the pivotal trial of envafolimab in MSI-H/dMMR cancer patients that were recently presented by the Company's corporate partners, 3D Medicines and Alphamab Oncology. In a presentation highlighting updated clinical results at the Chinese Society of Clinical Oncology 2020 Virtual Scientific Program entitled, "Subcutaneous Injection of PD-L1 Antibody Envafolimab in Advanced Tumors with Mismatch-Repair Deficiency," single agent envafolimab was shown to have a 32% confirmed objective response rate by central radiographic review of 41 patients with MSI-H/dMMR colorectal cancer who failed a fluoropyrimidine, oxaliplatin and irinotecan, and had at least two on-study tumor assessments. Duration of response was greater than or equal to 12 months in 75% of patients and overall survival was greater than or equal to 12 months in 65% of patients. The ORR in the overall population was 43%, DOR was greater than or equal to 12 months in 92% of patients and OS was greater than or equal to 12 months in 75% of patients. Envafolimab demonstrated good tolerability and safety and there continued to be no infusion-related reactions. Earlier data from this trial were presented by 3D Medicines and Alphamab Oncology at ASCO 2020, in a presentation entitled, "Envafolimab in Advanced Tumors with Mismatch-Repair Deficiency," at which time single agent envafolimab was shown to have a 28% confirmed ORR by central radiographic review in 39 patients with MSI-H/dMMR CRC who failed a fluoropyrimidine, oxaliplatin and irinotecan, and had at least two on-study tumor assessments. The trial enrolled 103 patients with MSI-H CRC, GC or with dMMR in other advanced solid tumors at clinical sites in China, in an open label format with efficacy endpoints, including the primary endpoint of confirmed ORR determined by independent central review. MSI-H/dMMR status was assessed centrally for CRC and GC and locally for other tumors. The confirmed ORR in MSI-H/dMMR colorectal cancer patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan reported at CSCO 2020 of 32% is similar to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR colorectal cancer patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan, and the 27.9% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan seen in cohort A of the pivotal KEYNOTE-164 trial.

08:26 EDT WeedMD secures expanded Health Canada license to sell all cannabis formats - WeedMD announced that it has secured an amendment to its Health Canada licences allowing the Company to produce, package, sell and distribute all cannabis formats directly from its 610,000-square-foot flagship cultivation and processing site in Strathroy, Ontario. WeedMD's hybrid-greenhouse in Strathroy is currently operating at full capacity under a 210,000 square foot canopy alongside additional drying and processing space. The Company's 27-acre, low-cost, outdoor grow, now in its second year of operation, is located on site along with a 50,000 square foot stand-alone, licensed processing facility dedicated for outdoor cannabis processing. The outdoor harvest is expected to kick-off in early October 2020 and will provide terpene-rich, high-cannabinoid input material for extraction and dried flower product formats such as pre-rolls and ready-to-roll. WeedMD's fully-licensed, extraction centre-of-excellence in Aylmer, ON produces the Company's cannabis derivatives, and its fully-licensed Bowmanville, ON facility houses the Company's medical fulfilment and distribution activities as well as its award-winning client services team.

08:24 EDT ATIF Holdings signs strategic collaboration with Zhuhai Boxin Technology - ATIF Holdings announced that through its viable interest entity, Qianhai Asia Times International Finance Services Co. Ltd., it has reached strategic cooperation with Zhuhai Boxin Technology Limited, to target explicitly at Zhuhai-based hi-tech enterprises as potential clients for the Company's online financial consulting services platform IPOEX.com. This is the third partnership aiming at in-depth collaborations reached between the Company and its invaluable partners within this month, following Dexin Dahua and Wenzhou Chamber of Commerce in Shenyang City. Based on the partnership, Boxin Tech will serve as one of IPOEX's corporate client channels, making fullest use of its rich experience in catering the needs of government-sponsored projects. Boxin Tech, together with IPOEX, will apply to Zhuhai City's relevant authorities to organize specialized consulting events, for the purpose of appealing to Zhuhai-based enterprises operating in internet and information technology, software design and other high-tech field to become members on IPOEX. In return IPOEX will provide all-encompassing, online and offline consulting services in global financial system, equity capital raising, project incubation and IPO advisory for these corporate clients.

08:21 EDT Onconova announces initiation Phase 1 trial of ON 123300 in China by partner - Onconova Therapeutics announced the initiation of a Phase 1 clinical trial in China for ON 123300 by its partner, HanX Biopharmaceuticals. In December 2017, Onconova entered into an agreement with HanX Biopharmaceuticals for the development, registration, and commercialization of ON 123300 in China. The agreement included a licensing fee, and future potential milestone payments and royalties on sales. Outside of China, Onconova retains rights in rest of the world. ON 123300 is a novel small molecule, and a dual inhibitor of CDK4/6 and ARK5, a key enzyme controlling cellular energy homeostasis. Inhibition of ARK5 by ON 123300 results in the collapse of oncogene-altered energy metabolism, leading to programmed cell death. Differentiated from health authority approved CDK4/6 inhibitors, ON 123300 exhibits single agent toxicity against various cancers in preclinical studies including breast cancer, colon cancer, mantle cell lymphoma and multiple myeloma.

08:19 EDT Liminal BioSciences: FDA confirms receipt of resubmission of BLA for Ryplazim - Liminal BioSciences announced that the U.S. FDA acknowledged receipt of the resubmission, by its US subsidiary, Prometic Biotherapeutics, of the Biologic License Application for Ryplazim for the treatment of clinical signs and symptoms associated with congenital plasminogen deficiency in pediatrics and adults. The FDA confirmed that the resubmission is a complete, Class 2 response and has provided a Prescription Drug User Fee Act target action date of March 5, 2021.

08:17 EDT Capstone Turbine gets orders for 10 C65 microturbines, totaling 650 kilowatts, - Capstone Turbine Corporation announced that it continues to have success in the European energy efficiency market with three separate orders for 10 C65 microturbines, totaling 650 kilowatts, kW, from various commercial industrial combined heat and power customers. E-quad Power Systems, Capstone's exclusive distributor in Germany and Luxembourg, secured the order, which is expected to be commissioned by the end of 2020.

08:15 EDT Enphase Energy announces partnership with three solar distribution companies - Enphase Energy announced it has entered into partnerships with three solar distribution companies in Belgium and the Netherlands- Carbomat Group, Libra Energy and Solarclarity, further strengthening Enphase's presence in the European solar market. The companies will distribute the Enphase IQ 7 family of microinverters to residential installers across Belgium and the Netherlands. In addition, the solar systems will be outfitted with Enphase Envoy communications gateways, which connect an Enphase-based solar system to the Enphase Enlighten monitoring platform and helps make per-panel energy monitoring and insights for operations and maintenance easy. Enphase has seen increasing demand for its microinverters in Belgium and the Netherlands. The residential sector, including households and social housing, along with small-sized businesses, has been the primary adopter of Enphase microinverter technology. New housing construction in Belgium and the Netherlands is also an important sector for Enphase due to the Company's unique ability to offer a truly future proof and scalable solar system design that is easy to install and offers excellent performance and reliability.

08:14 EDT Establishment Labs announces publication on hybrid breast reconstruction - Establishment Labs Holdings announced that a recently published independent study concluded that the hybrid breast reconstruction approach using Motiva Ergonomix implants improved outcomes in implant-based breast reconstructions. Published in Plastic and Reconstructive Surgery-Global Open, this independent study analyzed 56 prepectoral, hybrid breast reconstructions in 33 patients performed between 2014 to 2017. Utilizing the two-step, prepectoral reconstruction approach, the study found that Motiva Ergonomix implants allowed better control of the final breast shape, and complications related to submuscular approaches were avoided. The study further noted that Motiva Ergonomix implants "offer a wide set of advantages related to their surface features that can benefit short- and long-term adverse events related to chronic inflammation and fibrotic reaction."

08:13 EDT Toll Brothers reports preliminary quarter-to-date net signed contracts up 110% - Toll Brothers announced preliminary results regarding the Company's fourth quarter-to-date net signed new home contracts. Midway through the Company's FY 2020 fourth quarter, from August 1 through September 15, 2020, the Company's net signed contracts increased 110% year-over-year to 1,678 homes, compared with 800 homes for the same period in FY 2019. Average monthly per-community demand increased 114% over the same period to 3.6 contracts-per-community from 1.7 one year earlier. Douglas Yearley, Jr., chairman and CEO, stated: "The strong demand in our third quarter has continued into mid-September of our fourth quarter throughout our twenty-four states and across our product lines and price points. We continue to raise prices to manage the pace of growth, offset rising costs, and maximize profitability. We attribute the accelerated buyer demand to a number of factors, including historically low interest rates, a continued undersupply of homes, and a growing desire for a home that can be personalized for today's evolving lifestyles. Our luxury build-to-order business model is ideally suited to meet these trends. With our diversified product lines and well-located land, we believe we are positioned for growth in FY 2021, assuming market fundamentals remain favorable."

08:11 EDT I-MAB announces China NMPA clearance for Phase 1 trial of lemzoparlimab - I-Mab announced that the Center for Drug Evaluation of the China National Medical Products Administration has cleared the Investigational New Drug application for lemzoparlimab (also known as TJC4) to initiate a phase 1 clinical trial in patients with relapsed or refractory advanced lymphoma as part of an ongoing IMCT being conducted also in the U.S. Additionally, a phase 1/2a clinical trial in patients with relapsed or refractory acute myeloid leukemia in China is currently underway with clinical results expected in early 2021.

08:10 EDT IPG Photonics discloses detection of ransomware attack - In a regulatory filing, IPG Photonics disclosed that on September 14, the company detected a ransomware attack impacting certain of its operational and information technology systems. "Promptly upon its detection of the attack, the company initiated response protocols, launched an investigation and engaged the services of cybersecurity and forensics professionals. As of the date hereof, the company has recovered most of its critical operational data and business systems. Although the company is in the early stages of assessing the incident, based on the information currently known, the company does not expect the incident to have a material impact on its business, operations or financial condition. The company carries insurance, including cyber insurance, which it believes to be commensurate with its size and the nature of its operations," IPG Photonics stated in the filing.

08:10 EDT Nemaura Medical licenses validated mobile application Healthimation - Nemaura Medical announces it has licensed the rights to Healthimation mobile application based digital program, a well-validated and award-winning 12-week program to help patients manage their weight and pre-diabetes or early diabetes conditions. The program is intended to be combined with the company's proBEAT(TM)= non-invasive patch CGM for an enhanced behavioral change experience. Developed at a major diabetes center in the U.S. over more than 15 years, the digital program curriculum implements the most advanced approach to nutrition, exercise, and behavioral change and has been clinically tested and has demonstrated many benefits to a patient's overall health, including weight reduction, significant improvements in A1C, lipid profile, and blood pressure, and a reduction in medications taken. Healthimation, LLC has implemented this curriculum in an app that gamifies daily tasks and uses engaging high-quality animation and live coaching to encourage users to make healthy behavior changes, such as improvements in personal nutrition and exercise coaching, via the development and education of the app's avatar Lena. Through machine-learning technology, the software makes Lena "smarter", resulting in more personal recommendations for the patient over time. The Company believes that combination of the digital program with Nemaura's proBEAT offering expected to launch this year, will allow for more beneficial outcomes in patients with Type 2 diabetes, help prevent high-risk pre-diabetic patients from becoming diabetic, and possibly even lead to diabetes remission in some patients. The integrated offering offers numerous advantages in breadth of application and depth of features over other competing digital platforms on the market attempting to address the weight control and/or diabetes markets, many of which are more expensive and more invasive than the Company's anticipated solution. SugarBEAT, Nemaura's patented, CE marked, needle-free CGM that is non-invasive, affordable, and painless, is easily applied to the skin via a small unobtrusive patch. The device transmits blood glucose data to users and/or healthcare professionals via a mobile app to allow for better monitoring or treatment. The Company's BEATdiabetes is a planned health subscription service driven by the personalized data provided by sugarBEAT and processed through an artificial intelligence engine to provide personalized 1-on-1 lifestyle coaching and behavior change recommendations.

08:08 EDT Biocept: Highmark makes PCD on Target Selector liquid biopsy assay - Biocept announces that Highmark, America's fourth largest Blue Cross Blue Shield affiliate, has made a positive coverage determination that Biocept's Target Selector liquid biopsy assay has been accepted for medical coverage for use in the diagnosis and treatment of patients with non-small cell lung cancer. The coverage determination follows two years of evaluation performed by the Allegheny Health Network Cancer Institute of Biocept's liquid biopsy assay to more rapidly assess the molecular status of patients with NSCLC, enabling oncologists to select the most appropriate therapy while also reducing the overall cost of care.

08:07 EDT PolarityTE receives NIH grant for a point-of-care device to treat chronic wounds - PolarityTE announced it has received notification of being awarded a Phase I Small Business Innovation Research grant from the National Institutes of Health, NIH, for an application titled, "Fluid Management System for Point of Care Device for Novel Regenerative Treatment for Chronic Wounds." The Phase I grant, which totals approximately $245,000, is funded over a six-month period and will support research to apply for a subsequent larger Phase II grant. "I'm proud of the hard work the PolarityTE team dedicated to pursuing this grant and we are pleased to see that work validated by an award from the NIH," said David Seaburg, Chief Executive Officer of PolarityTE. Mr. Seaburg continued, "We will continue to leverage our scientific team's talent and pursue opportunities we believe will add value to the SkinTE franchise." "We are incredibly excited to receive this grant and look forward to working with the NIH to generate research supporting the development of a point-of-care device," said Dr. Nik Sopko, MD, PhD, Chief Scientific Officer. "We believe the ability to use products like SkinTE in a point-of-care setting will help many more patients gain access to novel treatments that can address unmet needs and deliver meaningful improvements to the standard of care."

08:06 EDT Kiniksa announces upcoming rilonacept analyst day - Kiniksa Pharmaceuticals (KNSA) announced that the company will host a virtual Rilonacept Analyst Day on Monday, September 28th, 2020 from 8:00 a.m. to 9:30 a.m. Eastern Daylight Time. The event will feature presentations from the Kiniksa management team on the market opportunity for rilonacept in recurrent pericarditis as well as the company's continued commercial preparations and launch strategy. Additionally, guest speaker Paul Cremer, MD, Cardiovascular Medicine, Cleveland Clinic, will review the burden of recurrent pericarditis, the current treatment landscape, and the unmet need. Rilonacept was discovered and developed by Regeneron Pharmaceuticals (REGN) and is approved by the U.S. Food and Drug Administration under the brand name ARCALYST for the treatment of Cryopyrin-Associated Periodic Syndromes. Kiniksa licensed rilonacept from Regeneron in 2017 for evaluation in diseases believed to be mediated by both interleukin-1 alpha and interleukin-1 beta, including recurrent pericarditis. The FDA granted Breakthrough Therapy designation to rilonacept for recurrent pericarditis in 2019 and Orphan Drug designation to rilonacept for pericarditis in 2020. Based on highly statistically significant Phase 3 data in recurrent pericarditis, the Biologic License Application for CAPS will transfer to Kiniksa, and the company plans to submit a supplemental Biologic License Application in recurrent pericarditis to the FDA this year. Upon receipt of FDA approval for rilonacept in recurrent pericarditis, Kiniksa will assume the sales and distribution of rilonacept for the approved indications in the United States and evenly split profits on sales with Regeneron.

08:05 EDT Catabasis Pharmaceuticals names Noah Clauser CFO - Catabasis Pharmaceuticals announced that it has promoted Noah Clauser to Chief Financial Officer. Mr. Clauser brings close to 20 years of financial experience to this role and has been with Catabasis for 9 years, most recently as Vice President, Finance. "Noah has strategically built our financial and operations functions and has been a valuable team member through a critical stage for Catabasis," said Jill C. Milne, Ph.D., Chief Executive Officer of Catabasis. "We are looking forward to his expanded role as we approach our potential future transition to a commercial organization." "I am excited for this new opportunity as we approach the next stage of our company, with top-line results from the Phase 3 PolarisDMD trial for edasalonexent expected in the fourth quarter of this year," said Mr. Clauser. "I am looking forward to continuing our work to make an impact in the lives of patients and families affected by Duchenne muscular dystrophy."

08:05 EDT ARCA Biopharma submits IND application for AB201 as potential COVID-19 treatment - ARCA biopharma announced it has submitted an Investigational New Drug application with the U.S. Food and Drug Administration under the Coronavirus Treatment Acceleration Program to evaluate AB201 for the treatment of patients hospitalized with COVID-19. Pending FDA feedback, ARCA anticipates initiating the Phase 2b portion of a sequential Phase 2b/3 clinical evaluation of AB201 as early as the fourth quarter of this year.

08:03 EDT Getty Realty CFO Danion Fielding announces intention to resign later this year - Getty Realty announced that Danion Fielding, the company's Vice President, Chief Financial Officer and Treasurer, intends to resign later this year for personal reasons. Current plans call for Fielding to continue to serve in his role until a successor can be found. Mr. Fielding's departure is not based on any disagreement with the Company's accounting principles, practices or financial statement disclosures. In connection with Fielding's departure, Getty has commenced a search for a new Chief Financial Officer and Treasurer.

08:02 EDT Whole Earth Brands CEO Albert Manzone appointed to board of directors - Whole Earth Brands announced the appointment of its CEO Albert Manzone, to the Company's board of directors effective September 18, 2020. Following Mr. Manzone's appointment, the Board of Directors will consist of seven members. Mr. Manzone has served as CEO of Whole Earth Brands since June 2020 and as CEO of the predecessor company, Flavors Holdings Inc., since February 2016 prior to the Company's business combination.

07:59 EDT Newmont to sell portfolio of eleven royalties to Maverix Metals for $90M - Newmont (NEM) announced that it has entered into a definitive agreement with Maverix Metals (MMX) to sell a portfolio of eleven royalties. Newmont will receive total consideration of approximately $90 million from Maverix, consisting of $15M in cash, 12M Maverix common shares, and up to $15M in contingent cash payments payable upon completion of certain milestones. The royalties provide exposure to five flagship gold assets owned and operated by growth-oriented mining companies. The portfolio includes royalties on Camino Rojo and Ana Paula in Mexico, Cerro Blanco in Guatemala, and Mother Lode and Imperial in the United States. The Transaction builds on Newmont's existing ownership interest in Maverix and provides the Company additional participation in the future upside of a growing royalty and streaming business. Maverix's diversified portfolio includes over 100 royalties and streams across 18 countries, with assets predominately located in Australia the Americas and Mexico. Closing of the Transaction is expected to occur in the fourth quarter of 2020 upon completion of customary closing conditions, and once completed, Newmont's ownership interest in Maverix will increase from 26 percent to approximately 32%. "This transaction further strengthens our strategic partnership with Maverix and generates additional value for our respective shareholders," said Tom Palmer, President and Chief Executive Officer. "We remain focused on continuing to optimize our portfolio and look forward to realizing further value through our position in Maverix."

07:44 EDT Adicet Bio down 13% to $18.61 after announcing 4.5M secondary offering

07:38 EDT Savaria appoints Stephen Reitknecht as CFO - Savaria Corporation announced the appointment of Stephen Reitknecht as CFO of Savaria effective September 21, 2020.

07:35 EDT MacroGenics announces $15M milestone triggered under Incyte agreement - MacroGenics (MGNX) announced that a $15M milestone payment has been triggered under its exclusive global collaboration and license agreement with Incyte (INCY) for retifanlimab, an investigational anti-PD-1 monoclonal antibody designed by MacroGenics and licensed to Incyte. The milestone was triggered by the initiation of the Phase 3 POD1UM-304 clinical trial, evaluating the efficacy and safety of retifanlimab with platinum-based chemotherapy in patients with metastatic squamous and non-squamous non-small cell lung cancer. MacroGenics and Incyte have each established multiple development programs for retifanlimab, evaluating the anti-PD-1 molecule either as monotherapy or in combination with other agents. Incyte is conducting clinical trials that are potentially registration-enabling for patients with metastatic NSCLC, squamous carcinoma of the anal canal, MSI-high endometrial cancer, Merkel cell carcinoma, and MacroGenics is conducting a potentially registration-enabling study in HER2-positive gastric cancer. Under the collaboration agreement with Incyte, MacroGenics is eligible to receive up to a total of $390M in potential remaining development and regulatory milestones and up to $330M in potential commercial milestones. If retifanlimab is approved and commercialized, MacroGenics would be eligible to receive royalties, tiered from 15 to 24 percent, on future worldwide net sales of the molecule.

07:32 EDT Crinetics receives rare pediatric disease designation for CRN04777 - Crinetics Pharmaceuticals announced that the U.S. Food and Drug Administration has granted rare pediatric disease designationfor CRN04777, an investigational, orally available, nonpeptide somatostatin receptor type 5 agonist being developed as a treatment for congenital hyperinsulinism. Congenital HI is a devastating rare disease in which infants are born with life threatening hypoglycemia due to excess insulin secretion.

07:22 EDT Northern Oil and Gas completes 1-for-10 reverse split, provides outlook - Northern completed the previously announced 1-for-10 reverse split of its common stock. The reverse split became effective on September 18 and Northern's common stock will start trading on a split-adjusted basis today. The company said, "Northern's unique non-operated model affords the Company the ability to be highly selective in its capital allocation process, both on its existing organic footprint and throughout a multitude of day to day Ground Game acquisition opportunities. With capital becoming increasingly scarce across the E&P industry, operators and non-operators alike are turning to external parties to solve their non-operated working interest budget needs. Given this environment, Northern has a superior opportunity set to deploy capital in high return prospective projects. The pipeline of visible investment opportunities currently stands in the hundreds of millions of dollars, both in the Williston Basin as well as the Permian Basin, where Northern announced its initial acquisition on September 10th. In addition, Northern continues to expect to end 2020 with approximately 30 net wells in process. Management remains focused on investing in assets that are in preeminent oil and gas basins, operated by best-in-class teams, and projected to meet stringent economic thresholds. To this point, any investment currently under consideration is required to be accretive to Northern's peer leading 2019 return on capital employed (ROCE). Armed with a growing opportunity set and a rigorous investment methodology, Northern continues to execute on its multi-year path to generate free cash flow, reduce debt, improve margins, and grow the business in a responsible manner."

07:18 EDT Virtusa sends letter to shareholders regarding BPEA transaction - Virtusa mailed a letter to shareholders related to the transaction with Baring Private Equity Asia, or BPEA, announced on September 10. The text of the letter follows: "At Virtusa's upcoming 2020 Annual Meeting of Stockholders on October 2nd (the "2020 Annual Meeting"), you will face an important, but clear, choice about the future value of your investment in our Company: the realization of maximum and certain return as soon as possible - $51.35 per share in cash - or the likelihood of disruption in the boardroom that could potentially delay your chance to receive that return on your investment... On September 10, 2020, Virtusa announced that funds affiliated with Baring Private Equity Asia (BPEA) will acquire all outstanding shares of common stock of Virtusa for $51.35 per share in an all-cash transaction valued at approximately $2.0 billion. While New Mountain Capital (NMC) may try to convince you otherwise, this compelling transaction that your Board negotiated and unanimously approved will deliver to you a maximum and certain return on your investment at a time of likely continued economic uncertainty. The all-cash consideration represents: A premium of approximately 27 percent to the closing price of Virtusa common stock on September 9, 2020, the last trading day prior to the transaction announcement; Premiums of approximately 29 percent and 46 percent to Virtusa's volume-weighted average prices ("VWAP") for the last 30 and 60 trading days, respectively; and, A valuation of 16.2x Firm Value / Last Twelve Months EBITDA as of June 30, 2020 - a premium valuation made all the more compelling by the volatile and risky macroeconomic and equity market environment... Not supporting the re-election of our two nominees and electing NMC's nominees instead at our upcoming Annual Meeting would put your investment return at risk. As we've detailed in prior letters to you, NMC's two candidates do not have unique skills, qualifications or perspectives required to add new value to our boardroom. Our Board already possesses essentially all of the qualities that NMC's candidates purportedly would bring. We already have independent directors with deep IT experience and industry pedigree, as well as significant shareholder representation on our Board. We also carefully evaluated NMC's strategic and operational recommendations and concluded that we were already addressing every one of them in the execution of the Plan and the ordinary course leadership of Virtusa. Even more importantly, electing NMC's candidates could potentially delay your ability to maximize the value of your investment through the BPEA transaction. NMC's agenda is to gain disproportionate influence over the Board, first by seeking to control 20 percent of board seats (despite owning only approximately 10 percent of the Company), and then by forming and leading a "Business Optimization Committee" that would effectively usurp the authority of the full Board of Directors. We strongly believe that, if elected, NMC's candidates would continue to pursue NMC's own agenda and could potentially seek to interfere with and delay the closing of the value-maximizing BPEA transaction and your receipt of $51.35 per share in cash. For example, NMC has made vague assertions about exploring "whether alternative transactions that are more beneficial to the Issuer's shareholders are available." Given the thorough market assessment we conducted before agreeing to the BPEA transaction, we are confident that there is no better alternative available for our shareholders. In summary, NMC's insistence on continuing with this proxy contest creates a needless distraction for our Company and shareholders at a crucial time, especially considering that shareholders will be voting separately on the merits of the BPEA transaction at a future date and, in the interim, will not benefit in any way from adding NMC candidates to our Board..."

07:15 EDT Materialise and Ditto team to advance digital technologies in the eyewear - Materialise announced that it has made a strategic investment in Ditto, a developer of virtual eyewear try-on platforms. In addition, the two companies will collaborate to advance the digital transformation in the eyewear industry and support the creation of new and personalized shopping experiences. The introduction of advanced digital technologies in the eyewear industry is creating new opportunities, including the possibility to offer personalized frame recommendations and virtual try-on solutions. As part of an end-to-end digital platform, frames can also be 3D printed. 3D printing supports the creation of unique and personalized designs, reduces stock risks and enables a more sustainable manufacturing process. Ditto partners with retailers, brands and eye care professionals to create personalized shopping experiences for eyewear customers. Ditto's platform captures a precise map of each customer's face and their personal style preferences to make insightful recommendations, determine precise fit and style, and visualize it all with vivid realism. In the process, their clients gain a deeper understanding of each customer that opens up new opportunities to better serve them across channels.

07:11 EDT Trevena announces presentations on TRV027, OLINVYK, TRV250 at ACCP meeting - Trevena announced three presentations at the virtual 2020 American College of Clinical Pharmacology Annual Meeting, taking place from September 21st to 23rd, 2020. The Company will give a live presentation on TRV027, its AT1 receptor selective agonist being studied as a potential treatment for ARDS / abnormal clotting in COVID-19. Additionally, the Company will present two posters highlighting previously published data for OLINVYK, which is approved in the U.S. for the management of acute pain, and TRV250, its delta receptor selective agonist being developed for the acute treatment of migraine. Poster Presentation Details: Live presentation: "The Use of Simulation in the Re-purposing of Drugs for COVID-19: The Example of TRV027": In a COVID-19 infection, the SARS-coronavirus-2 binds to and removes the ACE2 protein in the lungs and other organs, resulting in a hormonal imbalance of angiotensin 2 within the RAAS pathway, converging at the AT1 receptor. There is significant interest in the potential utility of TRV027 in COVID-19 patients, given its unique mechanism of action at the AT1 receptor, which is known to mediate the effects of angiotensin 2 on lung damage and abnormal coagulation. Simulations were conducted to determine potential therapeutic doses, which informed a proof-of-concept trial recently initiated by Imperial College London. The study will enroll 60 hospitalized, non-ventilated patients aged 18 or older with a confirmed COVID-19 infection. The primary objective of the study is to evaluate whether TRV027 reduces abnormal clotting associated with COVID-19. Poster presentation: "Improved Safety of Opioid Analgesic Oliceridine Compared to Morphine Assessed by Utility Function Analysis": OLINVYK was associated with a higher probability of analgesia than respiratory depression, while the reverse was true for morphine. The clinical utility function model predicted there would be a lower probability of a respiratory event occurring with OLINVYK versus morphine. Over the clinically relevant concentration range, OLINVYK had a higher probability of providing analgesia than producing respiratory depression, while morphine had a higher probability of producing respiratory depression than providing analgesia. Poster presentation: "A Phase 1 Healthy Volunteer Study of the Safety, Tolerability and Pharmacokinetics of TRV250, a G Protein-Selective Delta Receptor Agonist": TRV250 was well-tolerated up to 30 mg, with a PK profile appropriate for an acute migraine therapy. There were no serious adverse events and no clinically significant changes in EEG, ECG, or other safety parameters.

07:09 EDT CollPlant, United Therapeutics announce expansion of collaboration - CollPlant Biotechnologies (CLGN) and United Therapeutics (UTHR) announced an expansion of their collaboration with the exercise by United Therapeutics of its option to cover a second lifesaving organ, human kidneys. United Therapeutics paid CollPlant $3M for the option exercise. The collaboration agreement combines CollPlant's proprietary recombinant human collagen and BioInk technology with the regenerative medicine and organ manufacturing capabilities of United Therapeutics. The option exercise grants United Therapeutics through its wholly owned organ manufacturing and transplantation-focused subsidiary, Lung Biotechnology PBC, an exclusive license to CollPlant's technology for the production and use of rhCollagen-based BioInk for 3D bioprinting of human kidneys. This expanded collaboration is aimed at helping reduce global organ shortages and thereby potentially saving lives of millions of patients on kidney waiting lists.

07:09 EDT Mateon Therapeutics announces OT-101 presentation at Pharma Forum 2020 - Mateon Therapeutics announced that on September 21, 2020, Dr. Vuong Trieu, CEO of Mateon, will be presenting as Webinar "Trabedersen-Drug Development using phosphorothioate antisense platform" at Pharma Forum 2020/ Pharmacology and Toxicology/September 21, 2020. Of significant is the finding that cytokine levels of clinical plasma samples of 12 pancreatic cancer patients of the P001 study of OT-101 in advanced solid tumor patients were measured using the ImmunoSignal cytokine storm assay developed by Eurofins. Nine patients with elevated IL-6 were examined further. More than 50% of these patients exhibited significant reduction in IL-6 level following 1st cycle of dosing with OT-101. Of significant are pts 1041 and 1051 who exhibited a rebound following treatment stop on cycle 1 which decreased again on subsequent cycle 2. All patients exhibited elevated IL-6 on disease progression. The data are supportive of OT-101 against COVID-19 and in line with positive outcome recently reported for Roche's IL-6 inhibitor reported in the Empacta trial, Actemra used alongside standard of care reduced the risk of COVID-19 pneumonia patients advancing to mechanical ventilation or death by 44%.

07:07 EDT Bausch Health to acquire option to purchase Allegro ophthalmology assets - Bausch Health and Bausch + Lomb, and Allegro Ophthalmics, a privately held biopharmaceutical company focused on the development of novel therapies that regulate integrin functions for the treatment of ocular diseases, announced that Bausch Health has entered into an agreement to acquire an option to purchase all ophthalmology assets of Allegro, including global rights for risuteganib 1, Allegro's lead investigational compound in retina, which is believed to simultaneously act on the angiogenic, inflammatory and mitochondrial metabolic pathways implicated in diseases such as intermediate dry Age-related Macular Degeneration. The Option payment totaling $50M would be made in two tranches, with the first payment of $10M upon signing. Allegro intends to raise additional funding, following which, Bausch Health will make a second payment of $40M, which is expected to be made in 2021. If Bausch Health then elects to exercise the Option, additional payments will be payable.

07:05 EDT Agios announces final OS data from Phase 3 ClarIDHy study of TIBSOVO - Agios Pharmaceuticals announced the results of the final overall survival analysis from its global Phase 3 ClarIDHy trial of TIBSOVO in previously treated cholangiocarcinoma patients with an isocitrate dehydrogenase 1 mutation. A consistent trend in improved OS was observed in patients treated with TIBSOVO compared to those randomized to placebo, but was not statistically significant. The OS endpoint can be affected by crossover, so these results should be taken in the context of the large proportion of patients in the placebo arm who crossed over to receive TIBSOVO following radiographic disease progression; additional analyses performed to take crossover into account further support that TIBSOVO may improve OS. The safety profile observed in the study was consistent with previously published data. OS was a secondary endpoint in the ClarIDHy study; as previously announced, the study met its primary endpoint of progression-free survival. The company plans to submit a supplemental new drug application for TIBSOVO in previously treated IDH1-mutant cholangiocarcinoma in the first quarter of 2021 and intends to work closely with regulators on next steps. A full analysis of the ClarIDHy OS data will be submitted for presentation at a future medical meeting. The ClarIDHy trial is a global, randomized Phase 3 trial in previously treated IDH1-mutant cholangiocarcinoma patients who have documented disease progression following one or two systemic therapies in the advanced setting. Patients were randomized 2:1 to receive either single-agent TIBSOVO 500 mg once daily or placebo with crossover to TIBSOVO permitted at the time of documented radiographic progression per RECIST 1.1. As of the May 30, 2020 data cutoff, 185 patients were randomized, with 124 patients in the TIBSOVO arm and 61 patients in the placebo arm. Forty-three patients randomized to placebo crossed over to open-label TIBSOVO upon radiographic disease progression and unblinding. The primary endpoint of the ClarIDHy trial is progression-free survival as evaluated by independent radiology review. Results from the trial demonstrated a statistically significant improvement in PFS among patients randomized to TIBSOVO compared with placebo patients, with a median PFS of 2.7 months in the TIBSOVO arm versus a median PFS of 1.4 months in the placebo arm. The estimated PFS rate was 32% at six months and 22% at 12 months for patients randomized to TIBSOVO(R), while no patients randomized to placebo were free from progression or death beyond six months as of the data cut-off. Secondary endpoints include investigator-evaluated PFS, safety and tolerability, overall response rate, overall survival, duration of response, pharmacokinetics, pharmacodynamics and quality of life assessments. Data from the study were previously presented at the European Society for Medical Oncology Congress, held in September 2019 in Barcelona, Spain, and published in The Lancet Oncology on May 13, 2020. Based on these data, the National Comprehensive Cancer Network guidelines, the French National Treatment Guidelines for Biliary Cancer and the Italian Clinical Practice Guidelines on Cholangiocarcinoma were updated to recommend treatment with TIBSOVO for patients with advanced previously treated IDH1-mutant cholangiocarcinoma. TIBSOVO is not approved in any country for the treatment of patients with previously treated advanced IDH1-mutant cholangiocarcinoma.

07:04 EDT Becton Dickinson provides update on BD Alaris System recalls - Becton Dickinson provided an update on previously announced voluntary recalls of the BD Alaris System. Three of the recalls, which BD announced on August 4, have been designated as Class I recalls by the FDA, which means that FDA has determined that there is a reasonable probability that the use of the product will cause serious adverse health consequences or death. One of the situations was designated as a Class II recall, which means use of the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. This FDA classification does not change the guidance BD provided in the company's August 4 recall announcements to customers. BD initiated the voluntary recalls to notify customers of the potential for four hardware situations that may result in the infusion pump not operating as expected. BD has provided instructions to correct and/or mitigate the situations. The four recalls include: Alaris PC Unit Model 8015 Front Case with Keypad Replacement Kits; Alaris Pump Module Model 8100 Front Case with Keypad Replacement Kits; BD AlarisSyringe Module Model 8110 and PCA Module Model 8120; BD Alari EtCO2 Module model 8300 channel error.

07:02 EDT Axsome Therapeutics announces expedited development of AXS-12 for narcolepsy - Axsome Therapeutics announced that the development plan for AXS-12 for the treatment of narcolepsy has been expedited following a Breakthrough Therapy meeting with the U.S. Food and Drug Administration. AXS-12 is a novel, oral, highly selective and potent norepinephrine reuptake inhibitor for the treatment of narcolepsy. The expedited development plan includes one Phase 3 efficacy trial, which, along with the previously completed Phase 2 CONCERT trial, will be used to support the filing of an NDA or approval of AXS-12 for the treatment of cataplexy in narcolepsy. The planned Phase 3 trial will be a randomized, double-blind, placebo-controlled, parallel-group study. Axsome intends to initiate this trial in 1Q 2021. Patients completing this trial will be eligible to enroll in an open-label safety extension study. Also, as part of the expedited development plan, it was established that the data from numerous short-term and long-term clinical trials of patients treated with reboxetine, and the data from a full range of completed nonclinical studies with reboxetine, previously obtained through an exclusive license from Pfizer, can be used to support the filing of an NDA for AXS-12. One Phase 3 trial of AXS-12 in patients with narcolepsy will be conducted to support, along with the completed Phase 2 CONCERT trial, an NDA filing for AXS-12 in the treatment of cataplexy in narcolepsy. The existing short-term and long-term safety database of more than 2,500 patients treated with reboxetine, previously obtained through an exclusive license from Pfizer, along with the safety data from the completed and planned studies of AXS-12 in patients with narcolepsy, would be sufficient to support an NDA filing for AXS-12. Certain existing, completed clinical pharmacology studies of reboxetine, previously obtained through an exclusive license from Pfizer, are considered sufficient to support an NDA filing for AXS-12. The extensive package of completed nonclinical studies of reboxetine, previously obtained through an exclusive license from Pfizer, are considered sufficient to support an NDA filing for AXS-12. In August 2020, Axsome received Breakthrough Therapy designation from the FDA for AXS-12 for the treatment of cataplexy in narcolepsy. A Breakthrough Therapy designation is granted to potentially expedite development and review timelines for a promising investigational medicine when preliminary clinical evidence indicates it may demonstrate substantial improvement on one or more clinically significant endpoints over available therapies for a serious or life-threatening condition. The Breakthrough Therapy designation for AXS-12 for the treatment of cataplexy in narcolepsy was supported by the positive results from the Phase 2 CONCERT study, a randomized, double-blind, placebo-controlled, crossover, multicenter U.S. trial. In the trial, 21 patients with a diagnosis of narcolepsy with cataplexy were treated for 2 weeks with AXS-12 or with placebo, followed by a crossover to the other treatment after a 1-week down-titration and washout period. AXS-12 met the primary endpoint demonstrating a highly statistically significant reduction from baseline in the mean weekly number of cataplexy attacks, averaged for the 2-week treatment period, as compared to placebo, and at the end of the 2-week treatment period. AXS-12 also significantly improved excessive daytime sleepiness compared to placebo, as measured by the Epworth Sleepiness Scale and by the frequency of inadvertent naps. In addition, AXS-12 significantly improved cognitive function compared to placebo over the 2-week treatment period as measured by the Ability to Concentrate item of the Narcolepsy Symptom Assessment Questionnaire. AXS-12 was well tolerated in this trial with the most commonly reported adverse events being anxiety, constipation, and insomnia.

06:50 EDT AstraZeneca, Merck: LYNPARZA recommended for treatment of mCRPC, BRCA1/2 - AstraZeneca (AZN) and Merck (MRK) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending LYNPARZA for approval as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2 mutations who have progressed following a prior therapy that included a new hormonal agent.

06:46 EDT AstraZeneca, Merck: LYNPARZA recommended for approval in EU by CHMP - AstraZeneca (AZN) and Merck (MRK) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending LYNPARZA for the maintenance treatment of adult patients with advanced high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency-positive status defined by either a BRCA1/2 mutation and/or genomic instability. The positive opinion was based on a biomarker subgroup analysis of the Phase 3 PAOLA-1 trial, which was published in The New England Journal of Medicine.

06:34 EDT AdaptHealth names Frank Mullen as Chief Accounting Officer - AdaptHealth (AHCO) announced the appointment of Frank Mullen as Chief Accounting Officer, a newly created position. Mullen will report to Jason Clemens, AdapthHealth's CFO. Mullen brings over 25 years of public company accounting and finance leadership to AdaptHealth. He joins the company from Ryder System (R) where he served as Vice President and Controller.

06:17 EDT Strategic Education, Noodle Partners announce collaboration - Strategic Education and Noodle Partners announced that they will join forces to provide employers with a seamless approach to administering tuition assistance benefits. The partnership is designed to ensure the effectiveness of such benefits and to give covered employees access to affordable, relevant education options from top public and private schools.

06:13 EDT Aslan Pharmaceuticals opens new sites in ASLAN004 atopic dermatitis study - ASLAN Pharmaceuticals announced that clinical sites in the US and Australia are now open and ready to enrol patients into its multiple ascending dose study testing the first-in-class therapeutic antibody ASLAN004 in moderate to severe atopic dermatitis patients. Patients will now be recruited from 4 sites in Australia, 3 sites in the US alongside 2 existing sites in Singapore. ASLAN recently restarted recruitment into the second cohort of the randomised, double blind, placebo-controlled study in Singapore following the lifting of government restrictions in response to COVID-19. All 8 patients have now been fully recruited into the cohort and ASLAN plans to initiate recruitment into the third cohort following approval by the Data Monitoring Committee. A further 8 patients will be recruited in Singapore, the US and Australia. ASLAN expects to report interim, unblinded data from all 3 dose cohorts in 4Q 2020.

06:10 EDT Maxar Technologies awarded IDIQ contract valued at up to $49M - Maxar announced that it has been selected by the U.S. Army Geospatial Center to deliver multiple highly portable, direct-downlink tactical ground systems that provide critical geospatial intelligence to users in remote locations. Maxar was awarded a sole-source, indefinite-delivery/indefinite-quantity contract valued at up to $49M over eight years and two initial task orders worth a combined value of $8M.

06:09 EDT Axonics receives Health Canada Approval of next-generation INS - Axonics announced that Health Canada has approved its next generation rechargeable implantable neurostimulator for the Axonics r-SNM System. The next generation INS approved by Health Canada reduces how frequently a patient needs to recharge their implanted device to once a month for about one hour. Axonics received U.S. FDA approval for this version of its INS in April 2020. Health Canada previously approved the first generation Axonics r-SNM System in January 2017. Axonics is currently the only rechargeable SNM system available in Canada.

06:05 EDT PepsiCo aims to source 100% renewable electricity across operations by 2030 - PepsiCo announced a new target to source 100% renewable electricity across all of its company owned and controlled operations globally by 2030 and across its entire franchise and third-party operations by 2040. The transition has the potential to reduce approximately 2.5M metric tons of greenhouse gas, or GHG, emissions by 2040. This announcement builds upon the company's global efforts to increase its use of renewable energy sources and its transition to renewable electricity in the U.S., its largest market, announced earlier this year. PepsiCo currently procures renewable electricity in 18 countries, nine of which already meet 100% of their electricity demand from renewable sources. With the shift to renewable electricity in the U.S. underway this year, PepsiCo is currently on track to source 56% of its electricity through renewable sources globally by the end of 2020. To achieve 100% renewable electricity globally, PepsiCo will employ a diversified portfolio of solutions, including power purchase agreements, or PPAs, that will support the development of new projects such as solar and wind farms around the world, as well as through purchased energy certificates that will enable the near-term transition to renewable sources in many geographies. The company will also continue to expand its onsite wind and solar projects at its facilities around the world.

05:35 EDT Comscore expands TV measurement footprint with Samba TV partnership - Comscore announced its expanded TV measurement footprint driven by a new partnership with Samba TV. The launch of international Smart TV measurement capabilities will begin in select European markets. By working with new and existing partners, Comscore will now be able to deliver CTV measurement capabilities to markets around the world, following partnerships announced this year in Italy and Sweden. The new Smart TV measurement across linear, CTV, and over-the-top includes ad exposure data at the program and series level. The company said the new data will bolster ad effectiveness studies designed to help clients understand the extent to which their campaigns met ROI objectives, including purchase behavior and tune-in. As a result of this partnership, clients have already commenced new TV measurement projects in Europe. Comscore and Samba TV plan to expand into additional regions in 2021.

05:24 EDT Alexion receives CHMP recommendation for Ultomiris MAA in European Union - Alexion announced that the Committee for Medicinal Products for Human Use, or CHMP, has recommended marketing authorization in the European Union for a new 100 mg/mL intravenous, or IV, advanced formulation of Ultomiris. Ultomiris is a long-acting C5 inhibitor administered every eight weeks for the treatment of two ultra-rare diseases-paroxysmal nocturnal hemoglobinuria, or PNH, and atypical hemolytic uremic syndrome, or aHUS. Ultomiris 100 mg/mL would constitute an advancement in the treatment experience for patients with aHUS and PNH by reducing average annual infusion times by approximately 60% compared to Ultomiris 10 mg/mL while delivering comparable safety and efficacy. With Ultomiris 100 mg/mL, most patients will spend six hours or less a year receiving treatment.

05:17 EDT The9, Voodoo to collaborate on game publishing in mainland China - The9 announced that it has signed an agreement with Voodoo, a French game developer and publisher. The9 and Voodoo will collaborate on the publishing and operation of casual games in mainland China. The9 will publish and operate under this agreement two, with an option for a third, casual games with IAP, or in app purchases, licensed by Voodoo. Voodoo's games have been downloaded 3.7B times on iOS and Android phones cumulatively up-to-date, with monthly active users of 300M. Voodoo has released more than 100 games,

05:09 EDT Wheaton Precious Metals to seek secondary listing on London Stock Exchange - Wheaton Precious Metals announced its intention to seek the listing of its shares on the standard listing segment of the official list of the FCA and admission to trading on the main market for listed securities of the London Stock Exchange. This secondary listing is part of Wheaton's growth strategy. Subject to required regulatory approvals from the FCA and the LSE, including publication of a prospectus, the company intends to seek admission during Q4. The company is not intending to raise capital in conjunction with admission and will be retaining its primary listing on the Toronto Stock Exchange and dual listing on the New York Stock Exchange. Wheaton considers that admission to trading on the main market of the LSE, in addition to the company's current TSX and NYSE listings, will enhance the company's access to the pools of equity capital available in the United Kingdom and key financial centers in the EMEA region. This proposed listing will support the company's plans for growth and brings the first senior precious metal streaming company to the LSE.