Stockwinners Market Radar for May 14, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:38 EDT Great Panther Silver reports fatal accident at Mexico's Guanajuato Mine - Great Panther Mining is saddened to report a fatality has occurred at its Guanajuato Mine Complex in Mexico. The accident occurred today at approximately 9.30am CDT. The deceased, age 29, was a contract electrician at GMC. The accident involved a single motor vehicle travelling down a decline during care and maintenance activities. Another Great Panther contractor in the same vehicle was injured in the accident and has been transported to a local hospital, where he is in stable condition.

19:14 EDT Corporacion America Airport reports April passenger traffic down 98.3% - Corporacion America Airports reported a 98.3% decline year-over-year passenger traffic in April 2020. Total passenger traffic in April 2020 dropped 98.3% YoY, primarily reflecting continued travel restrictions imposed by governments, aiming to contain the spread of the COVID-19 pandemic. International traffic declined by 98.7% YoY, while domestic traffic dropped 98.2% YoY. In Argentina, total passenger traffic decreased 99.3% YoY, as a result of prolonged measures implemented mid-March by the Government restricting both international and domestic flights to contain the breakout. International passenger traffic declined 98.5% with minimum levels due to repatriation flights, while domestic passenger traffic dropped 99.7% YoY. In Italy, passenger traffic declined 99.9% YoY, with traffic at Florence airport down 100% YoY due to the temporary halt of operations from March 14 to May 4, 2020 as per government regulations, while passenger traffic at Pisa Airport was down 99.9% YoY. In Brazil, total passenger traffic dropped 96.2% YoY, driven by decreases of 95.5% in domestic passenger traffic and 99.4% in international traffic. Passenger traffic declined 98.5% YoY in Uruguay, 97.5% in Armenia and 98.6% in Ecuador.

18:44 EDT Abbott says NYU study of ID NOW not consistent with other studies

18:36 EDT Columbia Sportswear to reopen 30 U.S. stores - Columbia Sportswear will reopen 30 Columbia branded stores in ten states on Friday, May 15, bringing back more than 250 of its furloughed retail workers. Among steps being taken are requiring face coverings for employees, adjusting store layouts for social distancing, and delaying the restocking of clothes tried on in fitting rooms for 24 hours. In addition, employees will clean high touch points regularly and cashiers will wear gloves. As the company opens its stores, it will launch a checkout charity campaign to help fund relief efforts in the communities where it operates. The company delivered Columbia rain and fleece jackets along with cold-weather gear from Mountain Hardwear to healthcare workers in several states. The company expects to continue opening its US stores during the coming months with guidance from state and local authorities and communities.

18:17 EDT Clairvest acquires SunPower's solar operations business - Clairvest Group announced that it, together with Clairvest Equity Partners, acquired the solar operations and maintenance business of SunPower. Upon closing the business will be renamed NovaSource Power Services.

18:05 EDT Co-Diagnostics says COVID-19 test demonstrated 'excellent performance' - The company releases the prepared remarks for its Q1 earnings call, stating: "At the present time, timelines for effective coronavirus vaccines and therapeutics remain uncertain. What is widely known is that the need for testing on a mass scale continues to grow, as the U.S. and countries around the world strive to create COVID-safe schools, COVID-safe workspaces, and COVID-safe communities. In the United States for example there are more than 76 million students that need to be in school this fall along with 157 million workers who need to be at work. During the pandemic, Co-Diagnostics' ability to utilize its patented CoPrimer technology in highly accurate tests has significantly changed the trajectory of our Company. Co-Diagnostics was the first U.S. based company to receive a CE marking for its COVID-19 test, giving us an early entry into the European market as well as other areas of the world that accept CE marking as valid regulatory approval. In addition, being granted the FDA's emergency use authorization on April 3rd has been critical in fast-tracking the Company's COVID-19 diagnostic solution. We believe that test performance, combined with competitive pricing and high throughput attributes, makes for a compelling value proposition. Our COVID-19 test has been the subject of several independent studies validating its specificity and sensitivity, which have demonstrated its excellent performance characteristics."

17:53 EDT Applied says chip equipment sales 'may' rise in high single digit range in Q3 - The company said it is not providing revenue and earnings guidance for Q3 due to potential COVID-19 related disruptions but if current customer demand indications hold semiconductor systems revenue in Q3 may be up high single digits quarter-over-quarter, and higher again quarter over-quarter in Q4. This information is from a company slides presentation out after the close on Thursday.

17:23 EDT Lockheed Martin awarded $904.8M Navy contract modification - Lockheed Martin was awarded a $904.8M modification to a previously awarded firm-fixed-price, cost-plus-fixed-fee contract. This modification provides for the production and delivery of three MH-60R Seahawk maritime aircraft for the Navy and 21 MH-60Rs for the government of India. Work is expected to be complete by September 2024. FY20 aircraft procurement funds in the amount of $113.1M and Foreign Military Sales funds in the amount of $791.7M will be obligated at time of award, none of which will expire at the end of the current fiscal year. The Naval Air Systems Command is the contracting activity.

17:18 EDT Denny's reports Q1 domestic SSS down 6.3% - The company states: "Domestic system-wide same-store sales have sequentially improved over the last few weeks of April, as compared to the equivalent weeks of 2019, from the low of -80% experienced in the final week of the first fiscal quarter, which ended on March 25, 2020. As of May 13, 2020, 82% of domestic Denny's restaurants were operating, most with take-out and delivery options, streamlined menus, and reduced operating hours, which impacted same-store sales** results. Currently, 312 Denny's restaurants remain temporarily closed, including 272 domestic franchise restaurants and 40 international franchise restaurants."

17:07 EDT Office Depot announces restructuring plan, to cut 13,100 employees by 2023 - On May 13, Office Depot announced a restructuring plan to realign its operational focus to support its "business-to-business" solutions and IT services business units and improve costs. Implementation of the restructuring plan is expected to be substantially completed by the end of 2023. The company currently estimates it will incur incremental restructuring charges of up to approximately $543M, $194M of which will result in cash expenditures by the end of 2023. Such cash expenditures include $30M for supply chain capital investments and $21M for IT capital investments. The remaining $492M of estimated charges expected in the restructuring plan is comprised of one-time costs associated with potential retail store and distribution facility closures and related headcount reductions of which the company expects up to approximately $143M to be cash and $349M to be non-cash. The company expects to fund the cash charges with cash from operations and cash on hand. The restructuring plan includes closing and/or consolidating distribution facilities and retail stores and the reduction of approximately 13,100 employee positions by the end of 2023. The company is still evaluating the number of potential retail store and distribution facility closures, as well as the timing of any such closures. Total estimated non-cash charges consist of up to $106M for impairment of certain of the company's fixed assets with respect to anticipated store and distribution facility closures and up to $243M in non-cash charges related to store and facilities closures costs by the end of 2023. Estimated cash charges are expected to consist of approximately $55M for severance and other related employee costs and $88M for other restructuring related costs. The company expects the restructuring to result in up to approximately $860M in net savings by the end of 2023.

16:53 EDT Nike sees higher inventory having material impact on NA business in Q4 - "We are encouraged by the recovery we are seeing in Greater China and South Korea as we continue to deepen our connection to consumers," said John Donahoe, President and CEO of NIKE, Inc. "Even more so, consumers around the world are recognizing the need for an active and healthy lifestyle and sport is now more meaningful than ever. With our strong digital foundation, brand momentum and financial position, we believe this will be a catalyzing moment that strengthens NIKE's long-term future." "Since mid-March, the vast majority of NIKE-owned and wholesale partner stores outside Greater China and South Korea have been completely closed in order to protect the health and safety of our employees and help slow the spread of COVID-19. In light of store closures, product shipments to wholesale customers have slowed resulting in significantly lower wholesale revenue and higher inventory," the company said. "We continue to expect this to have a material impact on our NIKE Direct and wholesale operations in North America, EMEA and APLA in the fourth quarter."

16:45 EDT D.E. Shaw takes 5.1% passive stake 2U - D.E. Shaw disclosed a 5.1% stake in 2U, which represents over 3.2M shares. The filing does not allow for activism.

16:36 EDT Tyler Technologies Chairman John Marr sells $5.04M in company stock - Tyler Technologies Chairman John Marr sold 15,000 shares of company stock at $336.22 per share between May 12 and May 13 for a total transaction value of $5,043,320.

16:33 EDT Columbus McKinnon names David Wilson as President and CEO - Columbus McKinnon announced that its board has appointed David J. Wilson as President and CEO effective June 1, 2020. In conjunction with his appointment, Mr. Wilson will also be elected to serve on the Board of Directors of the Company. Mr. Wilson is the president of the Pumps Division of Flowserve Corporation (FLS), a provider of flow control products and services for the global infrastructure markets.

16:30 EDT Laredo Petroleum announces 1-for-20 reverse stock split - Laredo Petroleum announced that at the Company's Annual Meeting, its stockholders voted to approve a proposal authorizing the Company, at the discretion of the Board of Directors, to effect a reverse stock split of the Company's common stock at a ratio ranging from 1-for-5 to 1-for-20 of shares currently outstanding and a corresponding reduction in the number of authorized shares of the Company's common stock. Following the Company's Annual Meeting, the Board of Directors approved a 1-for-20 reverse stock split ratio. The reverse stock split is expected to become effective on or about June 1, 2020. If completed, the Company's stockholders will receive one new share of Laredo common stock for every 20 shares of Laredo common stock held prior to the effective date. Stockholders will receive cash in lieu of any fractional shares. If completed, the Company's common stock will begin trading on a split-adjusted basis on the New York Stock Exchange at the market open the day following the effective date. The reverse stock split is intended to increase the market price of the Company's common stock in order to regain compliance with the NYSE's continued listing standards. Once effective, the number of authorized shares of the Company's common stock will decrease from 450,000,000 to 22,500,000.

16:26 EDT Aurora Cannabis reports improved cash position of C$230.2M - C$154.6M in Q3 cash use represents a 43% decrease over prior quarter.

16:23 EDT Halozyme to receive $15M milestone payment from Johnson & Johnson's Janssen - Halozyme (HALO) will receive a $15M milestone payment from Janssen Biotech, a Johnson & Johnson (JNJ) company, triggered under the Collaboration and License Agreement between the two companies. The milestone payment is associated with the first commercial sale in the U.Sgreater than of Janssen's Darzalex Fasprotm utilizing Enhanze, recently approved by the FDA.

16:21 EDT Air Products to invest $2B for coal-to-methanol project in Indonesia - Air Products announced it has signed a definitive agreement for a long-term on-site contract for a world-scale coal-to-methanol production facility in Bengalon, East Kalimantan, Indonesia. Under the long-term on-site contract, PT. Bakrie Capital Indonesia, part of the Bakrie Group, and PT. Ithaca Resources, part of the PT. AP Investment, will supply the coal feedstock and have committed to offtake the methanol production for sale within Indonesia. Air Products will invest about $2B to build, own and operate the air separation, gasification, syngas clean-up, utilities and methanol production assets to produce methanol for Bakrie and Ithaca. This facility-including Air Products' proprietary Syngas Solutions dry-feed gasifier-will enable nearly two million tons per year of methanol to be produced from nearly six million TPY of coal. The project is expected onstream in 2024.

16:20 EDT Nike sees accelerated new member acquisition amid COVID-19 - Nike said: "As of today, 100 percent of NIKE-owned stores and over 95 percent of partner stores in Greater China and South Korea are open, with some still operating with reduced hours. In these markets, retail traffic trends are progressing and while physical store traffic remains below prior year levels, this is largely offset by higher conversion rates and continued strong digital demand." "Since mid-March, the vast majority of NIKE-owned and wholesale partner stores outside Greater China and South Korea have been completely closed in order to protect the health and safety of our employees and help slow the spread of COVID-19," the company continued. "In light of store closures, product shipments to wholesale customers have slowed resulting in significantly lower wholesale revenue and higher inventory. We continue to expect this to have a material impact on our NIKE Direct and wholesale operations in North America, EMEA and APLA in the fourth quarter. In the midst of the widespread physical store closures, we have been connecting and engaging with consumers leveraging the breadth of our digital ecosystem. Our strong digital footprint and capabilities are serving us well. We are seeing accelerated new member acquisition and strong digital demand across the global marketplace, with increased traffic and engagement on our mobile commerce and activity apps. We have increased our digital fulfillment capacity to meet this higher than anticipated demand which is partially offsetting declines in NIKE-owned stores. We have gradually reopened a small number of NIKE-owned stores across North America, EMEA and APLA as states and countries within each of these geographies ease quarantine measures and begin marketplace recovery. Specifically, store reopening has begun in over 15 countries including Germany, France, the Netherlands, Brazil and the United States. As of today, roughly 40 percent of our NIKE-owned stores in EMEA, 15 percent in APLA and 5 percent in North America, are open with some operating with reduced hours. Our wholesale partners in these countries have also begun to re-open stores. We remain focused on prioritizing the health of our teammates and consumers and continue to follow the advice and direction of local health authorities and governments. In preparation for stores reopening, we have taken appropriate steps to help ensure a safe retail environment including implementing social distancing and traffic control measures, increased product and facility sanitization, as well as providing face coverings to retail employees. In addition, we have maintained cleaning measures and social distancing policies in our distribution centers."

16:18 EDT Dillard's reports Q1 inventory down 14% - Reports retail gross margin 12.8% vs. 37.8% last year.

16:17 EDT New Relic names Seema Kumar chief marketing officer - New Relic announced the appointment of Seema Kumar as Chief Marketing Officer. Kumar is an accomplished go-to-market leader with experience driving success for high-growth SaaS companies, including Salesforce and ServiceChannel. Reporting to President and Chief Operating Officer Michael Christenson, Kumar will be responsible for the company's global marketing strategy and operations.

16:16 EDT Mersana Therapeutics initiates patient dosing in XMT-1592 dose escalation study - Mersana Therapeutics announced the initiation of patient dosing in a Phase 1 dose escalation study evaluating XMT-1592, its Dolasynthen ADC targeting NaPi2b. XMT-1592 is the company's first clinical candidate created using its new customizable and homogenous Dolasynthen ADC platform.

16:14 EDT AGNC Investment reports estimated tangible net book value of $15.22 per share - As of April 30. The estimate of tangible net book value includes deductions for the company's April dividend of 12c per common share, which was declared on April 8, with an April 30 record date.

16:12 EDT Denny's gives update on COVID-19 disruption - Domestic and international operations of Denny's and its franchisees have been significantly disrupted by the global COVID-19 pandemic due to related federal, state and local government responses that include "stay at home" directives and mandated dining room closures. The Company remains focused on the safety and well being of its guests, restaurant teams, franchisees, employees, and suppliers. Retraining materials and communications have been distributed to the entire system of restaurants, reinforcing strict food safety procedures, handwashing and personal hygiene standards, and enhanced daily deep cleaning protocols. These enhanced health and safety measures were developed in anticipation of dine-in service restrictions starting to ease and as Denny's restaurants prepare for new social-distancing standards in their dining rooms. The Company has remained in close contact with public health officials and government agencies to ensure all public health concerns are appropriately addressed.

16:07 EDT Covetrus names Matthew Foulston new CFO - Covetrus announced three additions to its senior leadership team, including global chief financial officer, president of its North American distribution business and global chief information officer. Matthew Foulston will become Covetrus' global chief financial officer effective June 1, 2020, replacing Stuart Gleichenhaus, who has been serving in that role on an interim basis since December 2019. Matthew Malenfant is the incoming president for Covetrus' North American distribution business, effective May 18, 2020. Recently, Malenfant was CEO of Saxco International, a leader in the packaging sector for beverage products. Steve Palmucci joined Covetrus on May 4, 2020 as global chief information officer, replacing Larry Rowland, who had been serving as a consultant and interim CIO since 2018.

16:04 EDT Aurora Cannabis reports Q3 kilograms sold 12,729 vs. 9,501 in Q2

16:03 EDT Farfetch reports Q1 GMV $610.8M vs. $419.3M last year

15:44 EDT Caladrius reports 'positive' results for CLBS16 from ESCaPE-CMD trial - Caladrius Biosciences presented full data results from the ESCaPE-CMD trial of Caladrius's autologous CD34+ cell therapy, CLBS16, at the Society for Cardiovascular Angiography and Interventions 2020 Scientific Sessions Virtual Conference. Data showed highly statistically significant improvement in coronary flow reserve correlating with symptom relief for patients with coronary microvascular dysfunction after a single intracoronary injection of CLBS16. "We are extremely pleased, yet not surprised, that the full results for the ESCaPE-CMD corroborate the previously reported and very positive partial data from the study," said Douglas Losordo, M.D., FACC, FAHA, Chief Medical Officer at Caladrius. "The results show an encouraging ability to increase CFR and potentially reverse CMD, a disease that disproportionately afflicts more women than men, after a single administration. The outcome from this study brings us one step closer to realizing the promise of CD34+ cell therapy to augment microvasculature in the heart enabling the restoration of health rather than simply management of disease. We look forward to initiating the next trial for this program, a Phase 2b study, in the fall of 2020."

15:29 EDT Delta to resume flights between Atlanta-Frankfurt and Detroit-London - Demand for air cargo is driving the return of Delta Air Lines' passenger services from the United States to Germany and the U.K. for the first time since the COVID-19 pandemic closed borders, the company announced. Beginning May 21, flights to Frankfurt and London will operate three times weekly from Atlanta and Detroit, respectively. The flights will also be available for customer travel. Delta is also launching scheduled cargo-only flights between New York-JFK and Mumbai, India, starting May 16, subject to foreign government approval. Reference Link

14:46 EDT Amazon to mass produce face shields for medical professionals - Amazon said on its blog: "The COVID-19 pandemic took communities by surprise. Protective equipment, like face shields for frontline medical staff, were, and continue to be, in short supply. In early March, a program manager at Amazon heard about a community group of 3D printing enthusiasts in Washington State that started making face shields for frontline workers. Comprised of makers and professionals of various vocations, this group had started to develop their own design and was building these by hand out of their homes and offices. Seeing the need, this Amazonian brought on colleagues from Prime Air's mechanical design and hardware teams. In no time, they were contributing solutions to this growing problem...Making sure the shields could be produced quickly and at scale, we produced a detailed open sourced design package for both 3D printing and injection molding. To date, Amazon has donated nearly 10,000 face shields and is on track to deliver 20,000 more in the coming weeks. To help quickly meet the growing requests from medical professionals across the country, we have decided to start mass-producing these face shields and aim to make hundreds of thousands available over the next few weeks, at-cost, on Amazon.com. Because of the design innovations and the capabilities of our supply chain, we are confident we will be able to list them at a significantly lower price - almost a third of the cost - than all other reusable face shields currently available to frontline workers. We are looking to prioritize frontline workers and then eventually open up to all Amazon customers." Reference Link

14:02 EDT KKR-backed AppLovin acquires Machine Zone, terms not disclosed - KKR-backed mobile game company AppLovin said in a blog post that it has agreed to acquire Machine Zone. Machine Zone is best known as the developer of high-grossing marquee titles including Game of War: Fire Age, Mobile Strike and Final Fantasy XV: A New Empire. "With this accelerated growth we will have to leave our first office (yes, we still have the first office we started out in back in 2011) to move one mile away to share Machine Zone's headquarters in Palo Alto," AppLovin said. "But, we are ready and excited about blending our superior technology and wicked smart employees under one roof. And, together we will continue our mission to grow the mobile gaming ecosystem - providing players with more interactive, fun games and supporting game developers by finding new and innovative tools to help them succeed." Reference Link

13:30 EDT Co-Diagnostics trading resumes

13:25 EDT Co-Diagnostics trading halted, volatility trading pause

13:00 EDT Intelsat trading resumes

12:41 EDT Air Products reports long-term supply contract with 'world-leading' PCB maker - Air Products announced it has been awarded another long-term onsite supply contract by "a world-leading printed circuit board and contract manufacturer in China." The company added: "Air Products' latest win will further enhance its strong supply position and onsite capacity to serve this customer and the fast-growing electronics markets. Air Products will add one large-volume high purity nitrogen generator to support the PCB and contract manufacturer's expansion in Northern China."

12:32 EDT Peltz says Fed should get rates close to zero as possible, not negative - Trian Partners CEO Nelson Peltz is speaking on CNBC.

12:30 EDT Peltz says GE Aviation will be good business if we start flying again - Trian Partners CEO Nelson Peltz is speaking on CNBC.

12:28 EDT Trian's Peltz says initiated two new stock positions - Trian Partners CEO Nelson Peltz is speaking on CNBC.

12:26 EDT Peltz says 'for sure' voting for Trump in 2020, loves his policies - Trian Partners CEO Nelson Peltz is speaking on CNBC.

12:24 EDT AIM ImmunoTech spikes 23% after FDA okays Ampligen trail in COVID-19 patients - Earlier on Thursday, AIM ImmunoTech announced that the U.S. Food and Drug Administration has authorized the first human trial assessing the safety and effectiveness of the company's lead asset, Ampligen , in combination with interferon alfa-2b, in cancer patients with COVID-19, the disease caused by the SARS-CoV-2 coronavirus. The company also provided a corporate business update and reported financial results for the first quarter ended March 31. The new clinical trial, to be conducted at Roswell Park Comprehensive Cancer Center under the leadership of Pawel Kalinski, MD, PhD, a pioneer in developing this combination as an investigational treatment for cancer, and Brahm Segal, MD, will test the safety of this combination regimen in patients with cancer and mild to moderate COVID-19, and the extent to which this therapy will promote clearance of the SARS-CoV-2 virus from the upper airway. The phase 1/2b study will enroll approximately 40 patients in two stages. Phase 1 will see 12-24 patients receiving both Ampligen and interferon alfa-2b at escalating doses. Once that initial phase is complete, further study participants will be randomized to two arms: one receiving the two-drug combination and a control group who will not receive Ampligen or interferon alfa but will receive best available care. AIM ImmunoTech intends to be a financial sponsor of the study and will provide Ampligen at no charge for this study. Additional information on the clinical trial is available at clinicaltrials.gov.

12:21 EDT Peltz says Procter & Gamble, Mondelez, Wendy's 'really good' companies - Trian Partners CEO Nelson Peltz is speaking on CNBC.

12:18 EDT Nelson Peltz says COVID 'won't last forever,' good values in market - Trian Partners CEO Nelson Peltz is speaking on CNBC.

12:05 EDT H&R Block intends to terminate Program Management Agreement with Axos Financial - Axos Financial (AX) disclosed this morning that on May 13, H&R Block (HRB) informed Axos that it intends to exercise its right to terminate the Program Management Agreement pursuant to a formal termination letter effective on or after July 1, 2020. Assuming a formal termination letter is received and the transaction volumes of activity for Emerald Card, Emerald Advance and Refund Transfer products for fiscal 2021 are similar to fiscal 2020 and there are no payments to Axos for transition services performed for H&R Block or the new bank, Axos sees the potential impact to operating results would be a reduction in net operating income for Emerald Card, Emerald Advance and Refund Transfer Products and administrative fees of approximately $21M or 35c per diluted share for fiscal 2021. In addition, the proposed termination of the PMA does not address the Refund Advance product, which is renewable annually. Assuming H&R Block elects to use another bank for Refund Advance, and the transaction volumes and pricing for the Refund Advance product for fiscal 2021 are similar to fiscal 2020 and there are no payments for transition services performed for H&R Block or the new bank, Axos says the potential impact on its operating results would be an additional reduction in net operating income for Refund Advance of approximately $10M or 17c per diluted share for fiscal 2021.

12:00 EDT Meredith falls -13.4% - Meredith is down -13.4%, or -$1.64 to $10.63.

12:00 EDT Comstock Resources falls -28.7% - Comstock Resources is down -28.7%, or -$1.86 to $4.63.

12:00 EDT Harmony Gold rises 8.1% - Harmony Gold is up 8.1%, or 28c to $3.81.

11:58 EDT Harsco director Phillip Widman purchased 25K shares of company stock - Harsco director Phillip Widman bought 25,000 shares of stock at $7.56 per share on May 14. The total transaction value of the purchase was $189,100.

11:18 EDT Sunnova Energy International Inc trading resumes

10:56 EDT FangDD Network Group Ltd (ADS) trading resumes

10:46 EDT FangDD Network Group Ltd (ADS) trading halted, volatility trading pause

10:35 EDT Norwegian Cruise Line: Most bookings represent new money

10:21 EDT Amazon launches Common Threads Vogue x Amazon Fashion - The COVID-19 pandemic has created an unprecedented time of financial stress and economic uncertainty for the fashion industry. Millions of people are losing their jobs, and retailers are struggling. Vogue and the Council of Fashion Designers of America (CFDA) first responded to the crisis in April by launching A Common Thread, a fundraising and storytelling initiative supporting those in the industry affected by the COVID-19 pandemic. A Common Thread was founded with the mission to support small and medium US fashion businesses with micro grants. With that as inspiration, Vogue, the CFDA, and Amazon have partnered on an online digital store front, Common Threads: Vogue x Amazon Fashion to help connect designers directly with consumers. In addition to helping create the store, Amazon has also donated $500,000 to A Common Thread. "I'm thrilled to announce this partnership, and want to thank Amazon Fashion, not only for its generous support of 'A Common Thread,' but also for so quickly sharing its resources to aid American designers affected by the pandemic," said Anna Wintour, Editor-in-Chief of Vogue, and U.S. Artistic Director and Global Content Advisor, Conde Nast. "While there isn't one simple fix for our industry, which has been hit so hard, I believe this is an important step in the right direction." Reference Link

10:13 EDT Norwegian Cruise: Furloughed employees retaining healthcare, other benefits

10:08 EDT Norwegian Cruise Line seeing cruise demand, particularly beginning in 4Q20 - Comments taken from Q1 earnings conference call.

10:03 EDT Tiziana Life Sciences announces publication of two Milciclib abstracts - Tiziana Life Sciences announces the online publication of two abstracts on clinical studies with Milciclib, a small molecule pan-inhibitor of cyclin dependent kinases in the proceedings of the virtual annual meeting of American Society of Clinical Oncology 2020. The first abstract reports Phase 2a clinical data with orally administered Milciclib in sorafenib-resistant hepatocellular carcinoma patients, for which it met the primary endpoint, that oral treatment with Milciclib was well tolerated with manageable toxicities and no recorded drug-related deaths, the company said. The second abstract reports preliminary clinical data from an ongoing investigator-originated trial with a combination of orally administered Milciclib and Regorafenib in liver transplant patients with recurrent HCC. Thus far, the study has shown mean AFP levels reduced by approximately 20% within one month of treatment, Tiziana added.

10:02 EDT Atlanticus Holdings trading halted, volatility trading pause

10:00 EDT ProShares Trust Ultra VIX Short Term Futures ETF rises 9.7% - ProShares Trust Ultra VIX Short Term Futures ETF is up 9.7%, or $4.26 to $48.32.

09:54 EDT MorphoSys announces long-term follow-up results from L-MIND study of tafasitamab - MorphoSys (MOR) and Incyte (INCY) reported updated results from the ongoing Phase 2 L-MIND study investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma, or r/r DLBCL. The results, based on a November 30, 2019 data cut-off, corroborate previously reported primary analysis data, the companies said. In this long-term analysis of the L-MIND data, 80 study patients receiving tafasitamab plus lenalidomide were included in the efficacy analysis. After a minimum of two years' follow-up, outcomes from the L-MIND study are consistent with the primary analysis and confirm the durability of the response and overall survival of tafasitamab in combination with lenalidomide followed by tafasitamab monotherapy in autologous stem cell transplantation-ineligible patients with r/r DLBCL. Assessment by an independent review committee at data cut-off showed an objective response rate of 58.8%, or 47 out of 80 patients, and a complete response rate of 41.3%, or 33 out of 80 patients. Median duration of response was 34.6 months, with median overall survival of 31.6 months and median progression-free survival of 16.2 months. The safety profile was consistent with that observed in previously reported studies of tafasitamab in combination with lenalidomide. The full analysis will be presented virtually at the EHA Annual Congress to be held June 11-14.

09:47 EDT Small Cap Bear 3x rises 6.0% - Small Cap Bear 3x is up 6.0%, or $2.32 to $41.30.

09:46 EDT Agios to present updated clinical proof-of-concept data on mitapivat at EHA - Agios Pharmaceuticals announced that mitapivat and ivosidenib clinical data will be presented at the European Hematology Association, or EHA, Annual Congress being held virtually June 11-14. The accepted abstracts are available online on the EHA meeting library website, noted the company, which also pointed out that all presentations can be accessed on demand by registered meeting attendees on the EHA Virtual Congress platform as of Friday, June 12 and will be accessible until October 15. Reference Link

09:37 EDT Alexion announces upcoming data presentations at virtual EHA meeting - Alexion Pharmaceuticals announced that five abstracts have been accepted for presentation at the 25th Congress of the European Hematology Association, or EHA, which will be held virtually from June 11 to 14. During the meeting, results will be presented from an interim analysis of the Phase 2 ULTOMIRIS 100 mg/mL formulation open-label study extension period. The 100 mg/mL formulation of ULTOMIRIS-a long-acting C5 inhibitor administered every eight weeks offering immediate, complete and sustained complement inhibition-was evaluated to determine if participants with paroxysmal nocturnal hemoglobinuria could achieve greater convenience by reducing infusion times, thus lessening demands on the healthcare system. "ULTOMIRIS is an important new standard of care for patients with PNH and atypical hemolytic uremic syndrome. An interim analysis of a PNH study evaluating the higher concentration formulation showed a 78-minute reduction in infusion time for adult patients in the 60-100kg cohort (representative of the majority of patients treated for PNH), and comparable safety, pharmacokinetics, and immunogenicity to the current formulation. This would reduce the time patients spend receiving their infusion-in clinic or in-home settings-lessening the overall burden on healthcare systems. We look forward to the opportunity to present these data during the virtually-held EHA meeting," said John Orloff, M.D., Executive Vice President and Head of Research and Development at Alexion.

09:34 EDT GATX completes sale of American Steamship Company business - GATX announced that it completed the sale of its American Steamship Company business to Rand Logistics for approximately $260M in cash proceeds. GATX expects to use the net sales proceeds to repay outstanding indebtedness under its $250M revolving credit facility.

09:31 EDT Terreno Realty acquires industrial property in Seattle for $5.6M - Terreno Realty acquired an industrial property located in Seattle, Washington for a purchase price of approximately $5.6M. The property consists of one industrial building containing approximately 13,000 square feet on 1.1 acres. The property provides three grade-level loading positions and excess yard and is 100% leased to one tenant through December 2021. The estimated stabilized cap rate of the property is 4%. Estimated stabilized cap rates are calculated as annualized cash basis net operating income stabilized to market occupancy divided by total acquisition cost. Total acquisition cost includes the initial purchase price, the effects of marking assumed debt to market, buyer's due diligence and closing costs, estimated near-term capital expenditures and leasing costs necessary to achieve stabilization.

09:30 EDT Kroger has hired more than 100,000 workers in past eight weeks - The Kroger Family of Companies announced it has hired more than 100,000 workers in the past eight weeks, including those from the hardest-hit sectors like restaurants, hotels and food service distributors. Prior to the crisis, Kroger's workforce topped 460,000 associates and recent hiring efforts have helped the retailer to provide continuous access to fresh, affordable food and essential products to communities during the pandemic. The Kroger Family of Companies has invested $700M since March to reward associates and safeguard associates, customers and communities, all of which was contemplated in the guidance provided in a business update on April 1.

09:28 EDT Verona Pharma to present overview of ENHANCE program on June 1 call - Verona Pharma plans to present an overview of its ENHANCE program on an investor and analyst R&D webcast at 7:30 a.m. EDT on Monday June 1, the company said. "The event will provide insight into the significant unmet need and challenges of treating COPD as well as further details of the ENHANCE program. In additional to members of Verona Pharma's management team, the webcast will feature a panel of Key Opinion Leaders in the field of COPD to provide a clinician's perspective...Verona Pharma continues to monitor the situation caused by the COVID-19 pandemic and its potential impact on its operational, planned clinical trials and the potential disruption to financial markets," the company noted.

09:24 EDT Zealand Pharma files NDA for HypoPal rescue pen

09:17 EDT Nvidia says Ampere Data Center GPU in full production - NVIDIA announced that the first GPU based on the NVIDIA Ampere architecture, the NVIDIA A100, is in full production and shipping to customers worldwide. The A100 draws on design breakthroughs in the NVIDIA Ampere architecture - offering the company's largest leap in performance to date within its eight generations of GPUs - to unify AI training and inference and boost performance by up to 20x over its predecessors. A universal workload accelerator, the A100 is also built for data analytics, scientific computing and cloud graphics.

09:16 EDT X4 Pharmaceuticals discloses efficacy, safety data from mavorixafor trial - X4 Pharmaceuticals disclosed efficacy and safety data from the Phase 2 open-label extension trial of its lead candidate mavorixafor in patients with Warts, Hypogammaglobulinemia, Infections, and Myelokathexis, or WHIM, syndrome. These data are included in an abstract published and selected to be presented as an e-poster at the European Hematology Association, or EHA, annual congress. The original Phase 2 clinical trial was a two-part, open-label, dose-escalation study of mavorixafor in adult patients followed by an open-label extension study to determine the safety, tolerability, and dose selection of mavorixafor in participants with genetically confirmed WHIM syndrome. The extension phase was open to patients who completed at least 24 weeks of the initial dose-escalation study and explored additional endpoints related to infection rates and wart burden, along with long-term safety. The trial results informed the design of the company's ongoing pivotal Phase 3 clinical trial. Data from the Phase 2 trial also resulted in the receipt of breakthrough therapy designation by the FDA for mavorixafor for the treatment of WHIM. Data from patients treated with 300 mg or 400 mg once-daily doses of mavorixafor for up to 28.6 months will be presented at this year's EHA Congress. The company observed sustained, dose-dependent increases in absolute neutrophil count and absolute lymphocyte count. Also, long-term hematological improvements correlated with fewer infections and improved cutaneous warts was observed as well. Clinical yearly infection rates decreased from 4.63 in the 12 months prior to the trial, to 2.41 at 300 mg and 2.14 at 400 mg of mavorixafor. Patients with cutaneous warts on hands and/or feet at baseline demonstrated a greater than 50% reduction in the number of warts at their last dermatological evaluation. Mavorixafor was well tolerated for the extended duration of more than two years without any attributable serious adverse effects.

09:14 EDT AeroVironment awarded $75.93M contract from U.S. Army - AeroVironment (AVAV) announced the receipt of a one-year, $75.93M funded contract award on April 30 from the United States Army for procurement of the company's Switchblade loitering missile system. The contract award was funded for the first year of procurement through a Joint Urgent Operational Need Statement from the United States Army Tactical Aviation and Ground Munitions project office. Start of deliveries is anticipated by September. Two additional one-year options, currently unfunded, would extend the period of performance through April 2023 on a sole-source basis. Northrop Grumman (NOC) is a key partner on the Switchblade system, providing single purpose and multimode warheads for the program.

09:12 EDT Ford: 'It's in everyone's interest to get our stock back up'

09:11 EDT ServiceSource extends collaboration with Red Hat - ServiceSource (SREV) announced that it has extended its relationship with Red Hat (RHT). Through a new agreement, ServiceSource builds upon its history of strong collaboration, focused on supporting Red Hat's mid-market customer relationships. ServiceSource's customer success experts will add a layer of high-touch onboarding and customer health checks as part of an initiative designed to expand and renew Red Hat's existing customer footprint.

09:10 EDT Tecogen secures maintenance contract with Toronto recreational facility - Tecogen announced it has signed a two year maintenance contract for 4 InVerde e+ systems with a recreational facility in Toronto. The facility purchased and installed the units in 2019 with maintenance initially provided by a third party. Tecogen was able to secure the contract with the owners of the facility based on the new factory service center established in the Toronto area earlier in the year.

09:09 EDT Ping Identity appoints Candace Worley as Chief Product Officer Business Wire - - Ping Identity (PING) announced Candace Worley has joined the company's leadership team as global chief product officer. Worley brings over 25 years of enterprise strategy and product development experience from some of the largest names in the technology sector. At Ping Identity, Worley will be responsible for advancing the global product vision, leading technical product innovation efforts and bringing the company's premier identity solutions to market. Worley hails from Amazon Web Services (AMZN) where she most recently led the enterprise strategists and vertical marketing teams.

09:07 EDT INmune Bio on track to report data in XPro1595 Phase 1 study in October

09:06 EDT Ford CEO: 'Nagging' warranty problems are improving

09:05 EDT Sierra Oncology reports positive dose intensity and safety data at EHA Congress - Sierra Oncology announced that Dose Intensity and Long-Term Safety data for momelotinib will be presented in two posters at the 25th European Hematology Association - EHA - Virtual Congress June 11-21. "In these new analyses of data from the previously completed Phase 3 SIMPLIFY studies, momelotinib displayed favorable long-term efficacy, safety and tolerability consistent with its differentiated pharmacological and clinical profile. These data reinforce the remarkable durability of momelotinib treatment, which was achieved while maintaining sustained active and well tolerated dose intensity," said Barbara Klencke, Chief Development Officer. "Specifically, momelotinib showed an absence of significant rates of high-grade hematological and other toxicities, which reinforce the compound's potential to safely and effectively address the unmet needs of patients with intermediate/high risk myelofibrosis. Importantly, no new safety signals or evidence of cumulative toxicity were observed during extended momelotinib daily dosing." Sierra is currently enrolling patients in the MOMENTUM clinical trial for patients with myelofibrosis. Data from MOMENTUM, along with data from more than 820 myelofibrosis patients previously treated with momelotinib in prior clinical studies, will form the basis of the global registration strategy for momelotinib.

09:03 EDT Ford CEO: Explorer launch 'disrupted shareholder returns'

08:58 EDT Vaccinex CEO says doesn't see trials 'materially impacted' by pandemic - "During the first quarter and subsequent period, we took significant steps that we believe strengthen our balance sheet as we look to conclusion of important trials of our lead clinical candidate pepinemab in both Huntington's disease and non-small cell lung cancer," said Maurice Zauderer, Ph.D., President and Chief Executive Officer of Vaccinex. "And while the COVID-19 pandemic has created unprecedented disruptions and uncertainty affecting clinical development timelines around the world, we continue to engage with our trial sites and, given the advanced stage of both trials, we do not currently anticipate that these trials will be materially impacted by the pandemic. In parallel, we continue to advance plans to leverage our work in Huntington's disease and initiate a formal study of pepinemab in Alzheimer's disease when trial sites are again permitted to safely enroll patients. Both Huntington's and Alzheimer's are slowly progressive neurodegenerative diseases characterized by the activation of inflammatory cells in the brain. As we recently presented at this year's AAT-AD/PD(TM) Focus Meeting 2020, we believe pepinemab can block the upregulation of SEMA4D and the activation of glial cells in HD and AD patients, leading to a reduction in disease progression and improved long-term patient outcomes. We look forward to initiating our work in AD as soon as practicable," Dr. Zauderer concluded.

08:52 EDT Ford wants to resume dividend 'as soon as practical' - Comments taken from Ford's annual meeting of shareholders.

08:51 EDT Flowr announces partnership with Terrace Global to fund Holigen - The Flowr Corporation announces it has entered into an Equity Line and Profit Sharing Agreement with Terrace Global, whereby the two companies will work together to develop finished cannabis products for the European medicinal market. As part of the Partnership and under the terms of the Agreement, Terrace Global has agreed to fund the operations and certain capital expenditures at the Company's outdoor facility located in Aljustrel, Portugal in exchange for common shares and warrants in Flowr to be issued in certain intervals during 2020 and sharing of net proceeds from the sale of any medical cannabis products produced from the facility. The parties expect Terrace Global to fund at least C$3 million under this Partnership. The Partnership allows for both companies to participate in the planting, growing, cultivation, harvesting and production of high-quality medical cannabis. The Agreement contemplates advancing the planting of up to 12 hectares of land at Aljustrel in 2020 to cultivate medicinal cannabis for the European market. The goal of the Partnership is to develop various strains suitable for the European medicinal market and planting mechanisms which will determine the most effective and efficient systems to grow cannabis outdoors in Portugal. Flowr recently exported to Portugal approximately 14,000 clones to support Holigen's 2020 planting season. The cultivars which were shipped include Flowr's flagship strain BC Pink Kush as well as BC Louis XII and BC Tahoe OG, which were strains successfully grown in Flowr's Canadian outdoor operation, Flowr Forest, and which will be launched in the Canadian recreational market soon as new products. All three of these strains have THC content in excess of 20%. The Agreement provides for the establishment and approval of cultivation plans and operating budgets to be approved by Flowr and Terrace Global. Once approved, Terrace Global will provide Flowr with the full amount of funds required by such Program. It is expected that the Company will begin initial planting efforts in Aljustrel immediately. The products created under the terms of the Agreement will be sold by Flowr under the Holigen brand in Europe, and Terrace Global will share in 25% of the net proceeds of sales of such product, which percentage may be reduced to 20% in certain circumstances. The common shares to be issued to Terrace Global in exchange for the funding of the Program will be issued at a price equal to the volume weighted average trading price of the common shares on the day prior to the day of such subscription less the maximum applicable discount available under the rules of the TSX Venture Exchange, subject in all circumstances to a minimum price of $0.52 per common share, as is determined by dividing the amount of the approved budget by such price. In addition, upon issuance of common shares under the Agreement, Terrace Global will be entitled to an equal number of whole warrants, with each warrant being exercisable to purchase one common share for a period of thirty-six (36) months at an exercise price equal to the greater of $0.76 per common share and the minimum exercise price permitted at that time under the rules of the TSX Venture Exchange. The transactions contemplated by the Agreement are subject to the approval of the TSXV. In addition, Flowr also announced today that 75,000 incentive stock options and 50,000 restricted share units have been granted to an officer of the Company. The Options are exercisable at a price of $0.64. The Options and RSUs will vest in equal tranches of thirty-three and one-third percent over a period of three years.

08:48 EDT Enphase Energy chosen by Flywheel Development for solar projects - Enphase Energy announced that Flywheel Development LLC has selected Enphase microinverters as the inverter technology of record for its portfolio of commercial solar projects. Based in Washington D.C., Flywheel Development is a leading sustainable development company active in real estate, sustainable design, solar development, and stormwater management infrastructure, with a focus on high-performance, net-zero buildings. Flywheel has standardized its portfolio of commercial and multi-unit dwelling solar projects on Enphase microinverters due to their high degree of design flexibility. Among the Flywheel solar project portfolio in the greater D.C. area is Nicholas Landing, a newly constructed, nine-unit housing development owned by the Housing Commission of Talbot County, Maryland, and funded in part by the Maryland Department of Housing and Community Development. Nicholas Landing complements the architectural style of the surrounding structures and therefore required Flywheel to design a solar system that spans the shared roofs of the buildings across numerous, variably pitched planes. To meet the requirement for an equitable distribution of energy output to each of the residential units, Flywheel used HelioScope solar design software to determine which combination of differently oriented solar modules should interconnect to each of the nine units. The distributed architecture, which underpins the Enphase microinverter system, allowed for maximum flexibility in defining the ideal combination of modules on each AC branch circuit.

08:41 EDT Delta Air Lines to further consider early aircraft retirements

08:41 EDT Delta Air Lines: Retiring 777 fleet 'not an easy decision'

08:40 EDT Tracon Pharmaceuticals presents clinical data for Envafolimab - TRACON Pharmaceuticals announced that positive data from envafolimab in a pivotal trial in China for the treatment of MSI-H/dMMR cancer will be presented by the Company's corporate partners, 3D Medicines and Alphamab, at the American Society of Clinical Oncology 2020 Virtual Scientific Program. ASCO abstract #3021 entitled "Envafolimab in Advanced Tumors with Mismatch-Repair Deficiency" reviewed data available on December 17, 2019 from the ongoing pivotal Phase 2 trial of envafolimab given by subcutaneous injection without an adjuvant in MSI-H/dMMR cancer. The trial enrolled 103 patients with MSI-H colorectal or gastric cancer or with dMMR in other advanced solid tumors, in an open label format with efficacy endpoints, including the primary endpoint of confirmed objective response rate determined by independent central review. MSI-H/dMMR status was assessed centrally for CRC and GC and locally for other tumors. Key highlights included: The confirmed ORR in 50 patients with CRC who failed a fluoropyrimidine, oxaliplatin and irinotecan plus those with advanced GC who failed at least one prior systemic treatment, with at least two on-study tumor assessments, was 30%, of whom 80% were responding with median follow-up of 7.5 months at the time of the data cutoff. The confirmed ORR in the overall population was 34%, of whom 86% were responding with median follow-up of 6.7 months at the time of the data cutoff. The confirmed ORR in 24 patients with CRC who failed a fluoropyrimidine and oxaliplatin or irinotecan was 54% of whom 85% were responding at the time of the data cutoff. Envafolimab was well tolerated with a safety profile similar to that of approved PD-1 checkpoint inhibitors but without infusion related reactions.

08:39 EDT Delta Air Lines authorizes plan to retire Boeing 777 aircraft

08:37 EDT Predictive Oncology licensing NSP10 technology for COVID-19 vaccine - Predictive Oncology has, with the announced acquisition of Soluble Therapeutics and the subsequent partnership and licensing of a novel nanoparticle vaccine technology platform recently developed by Dr. Daniel Carter, entered the race to develop a COVID19 vaccine. The ground-breaking vaccine technology is based on a self-assembling nanoparticle called NSP10 which follows a foundational vaccine platform developed earlier by Dr. Carter and his team, using another self-assembling protein called ferritin. NSP10 Nanoparticle has special surface properties that allow for the rapid design and display of viral receptor stems for virtually any virus, making it extremely versatile. Previous vaccine studies of NSP10-based Nanoparticles in rabbits produced exceptionally high titers against a herpes viral protein called glycoprotein D, normally non-highly antigenic. Titers in this case ranged from 1:1,000 with a simple injection of 500 micrograms of plasmid DNA, to as much as 1:25,000 after a second booster - all without the use of adjuvants or transfection agents. To our knowledge, this is unprecedented and revolutionary for a DNA vaccine. The exact reasons why the NSP10-based Nanoparticles exhibit these properties is still a subject of study, but scientists know that nanoparticles are processed differently by the immune system and smaller nanoparticles can often produce higher titers - NSP is one of the smallest currently evaluated. The level of titer is important for many reasons, for example, earlier animal experiments with vaccines focused on severe acute respiratory syndrome and Middle East respiratory syndrome found that low antibody levels could potentially lead to dysfunctional immune responses, increasing infection and damaging the lungs. In addition to enhanced protective immunity, stronger titers mean that it takes less vaccine per dose which has added advantages in safety and production scale. In the special case of NSP10-based vaccines, as it translates to humans, this could mean that a single gram of plasmid DNA can potentially immunize as many as 2,000 people, perhaps more.

08:36 EDT Amyris receives GRAS validation for new health and nutrition ingredient - Amyris' first health and nutrition ingredient received a validation by a unanimous Panel of Medical Experts as Generally Recognized As Safe, or GRAS. Following this successful validation, Amyris will submit an application for FDA GRAS approval of this ingredient. The ingredient is currently not being named due to partner's requirements.

08:32 EDT ClearSign Combustion receives multi-flare order from ASHCOR - ClearSign has received an order from collaborative partner ASHCOR for ClearSign Core flare technology systems to build into four ultra low NOx emission produced gas flares destined for a Southern California operator. The flares were sold and will be installed by mutual channel affiliate International Combustion and Controls, a Division of California Boiler.

08:31 EDT Legacy Acquisition Corp intends to adjourn Special Meeting of Stockholders - Legacy Acquisition Corp. announced that it intends to convene and then adjourn, without conducting any other business, Legacy's special meeting of its stockholders, scheduled to occur on Monday, May 18, 2020 at 4:00 p.m., Eastern Time. The adjournment is intended to provide additional time for negotiations regarding the PIPE Financing and the terms of the Share Exchange Agreement. The date and time to reconvene the Special Meeting will be determined by Legacy's board of directors and announced at a later time. The Special Meeting is being held to vote on the proposals described in Legacy's definitive proxy statement, filed with the Securities and Exchange Commission on March 31, 2020, relating to its proposed business combination with a wholly-owned holding company of Blue Valor Limited, a company incorporated in Hong Kong, which will hold a digital-first, intelligent and integrated, global advertising & marketing services group.

08:26 EDT Pluristem provides 28-day follow up for ventilator-dependent COVID-19 patients - Pluristem Therapeutics reported an update on the status of COVID-19 infected patients treated with PLX cells under a compassionate use program in Israel and the FDA Single Patient Expanded Access Program in the U.S. All treated patients were in Intensive Care Units, on invasive mechanical ventilation and suffered from Acute Respiratory Distress Syndrome at the time of treatment. As of today, a total of 18 patients were treated in Israel and in the U.S., of which 8 so far have completed a 28-day follow up period. 28-day follow up highlights for 8 patients treated with PLX cells: The survival rate of the 8 patients treated with PLX cells was 87.5%. 75% were off any mechanical ventilation. 62.5% were discharged alive from the hospital compared to 3.3% in data published in the NY area during March-April 2020 for patients requiring mechanical ventilation and discharged alive. Notwithstanding the Company's prior intention not to provide further updates on the status of patients treated under compassionate use, the Company is now providing this update in response to a substantial increase in shareholder inquiries, following the FDA clearance of Phase II study and prior to recruitment of the first patient. The Company intends to provide a final update regarding the compassionate use program in Israel and the FDA Single Patient Expanded Access Program in the U.S. once it has completed such programs and after it has completed its previously announced Phase II study with respect to the use of its PLX cells for the treatment of severe COVID-19 cases complicated by ARDS.

08:22 EDT Krystal Biotech announces interim results from Phase 1/2 trial of KB105 - Krystal Biotech announced interim results for a first-in-human Phase 1/2 placebo controlled clinical trial evaluating topical administration of KB105 in patients with autosomal recessive congenital ichthyosis being presented at the Society for Investigative Dermatology annual meeting. Following today's results, Krystal plans to enroll pediatric patients in the Phase 2 portion of the clinical trial. The interim results summarize data from three adult patients, aged 39, 24, and 20 years old who participated in a randomized placebo-controlled study to receive either topical KB105 or placebo in circular skin areas of 20cm. The KB105 treated areas were biopsied following a single treatment to assess onset of expression and following multiple repeat administrations to assess durability and efficacy of repeat dosing. Safety data from all three patients showed that repeat dosing with KB105 was well-tolerated with no drug related adverse events and no immune response to the HSV modified vector or TGM1. Also, no vector shedding or systemic exposure was detected in any of the three patients. KB105-treated areas showed clearly detectable TGM-1 expression in all treated sites following initial and repeat administration. KB105-expressed TGM1 was correctly localized in the epidermis, co-localizing with loricrin, and was functionally active. QPCR, immunofluorescence and in situ analysis demonstrated similar delivery efficacy of TGM1 DNA from single and repeat administration. Phenotypic evaluation was limited by small treatment areas, but KB105 treated areas showed reduced reversion to disease phenotype. Micro-needling pre-treatment did not show any significant increase in expression when compared to direct topical administration without micro-needling, especially after repeated application. Krystal plans to initiate a Phase 2 study in pediatric patients in the second half of 2020. The Company hopes to incorporate the new ichthyosis severity score scale into studies for clinical validation.

08:17 EDT CareDx, Veracyte announce exclusive partnership for - CareDx (CDNA) and Veracyte (VCYT) announced an agreement through which CareDx will become the exclusive worldwide commercialization partner for solid organ transplant-rejection tests on the nCounter FLEX Analysis System, Veracyte's diagnostic platform. CareDx previously announced plans in September 2019 to develop HistoMap, a gene expression profiling solution to identify allograft rejection in transplant biopsy tissue. HistoMap will run on the nCounter FLEX Analysis System and will be developed using the Human Organ Transplant, or HOT, panel from the Banff Foundation for Allograft Pathology. CareDx will be responsible for the global commercialization of HistoMap. This agreement marks Veracyte's first diagnostics company partnership that is designed to expand the menu of genomic tests it offers on the nCounter instrument since acquiring the global diagnostic rights to the platform from NanoString Technologies in December 2019.

08:15 EDT Kratos Mobile Laboratory product supports COVID-19 response efforts - Kratos Defense & Security Solutions announced that its Mobile Laboratory Product, developed in part by the Kratos Command, Control, Communications, Computing, Combat & Intelligence, Surveillance and Reconnaissance Division for the Department of Defense's Analytical Laboratory System, Modified Work Order program, has been deployed as part of the National Guard's efforts to combat COVID-19. The ALS program, run through the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense, provides a common, mobile laboratory capability to DoD field analytic units across multiple domain spaces. The system provides on-site capability to detect and/or identify a wide range of CBRNE materials in environmental samples. These mobile units have been adapted to conduct clinical specimen testing in support of COVID-19 response efforts and are being deployed to the epicenters of the pandemic within the United States to provide additional laboratory capacity and capabilities to support increased testing activities.

08:14 EDT TiVo announces partnership with University of Waterloo - TiVo announces an innovative partnership with the University of Waterloo that will begin with a project investigating methods to enhance the user quality-of-experience for 360 degrees omnidirectional video on head-mounted devices. The research will be led by the University of Waterloo's Professor Zhou Wang, whose research includes signal and image processing, computational vision and pattern analysis, multimedia coding and communications, and biomedical signal and image processing. The first phase of the partnership will be a project targeting the development of perceptual quality-of-experience assessment methods, with the further aim of developing perceptual encoding and streaming methods to improve performance, resulting in contributions to the practical use and standardization of 360 degrees omnidirectional videos used in, among other applications, immersive content experiences. This creative project will enable the University to further the impressive research done by Dr. Wang while adding innovation to TiVo's world-class patent portfolio.

08:13 EDT Materion raises quarterly dividend to 11.5c per share - Materion announced that its board declared a Q2 dividend of 11.5c per share of common stock, an increase of $0.005 per share, or approximately 5%. The dividend is payable on June 10, to shareholders of record at the close of business on May 29. On an annualized basis, the amount of the dividend is 46c per share and equates to a yield of approximately 1% based on the Materion common stock price at the close of trading on May 13.

08:12 EDT Histogen publishes preclinical data on HST 004 Spinal Disc program - Histogen announced the publication of data on HST 004, its patented, naturally-derived material for spinal disc repair in the Journal of Medicine and Surgical Sciences. Histogen has developed a cell conditioned media that is embryonic-like in composition and that has been shown to stimulate stem cells in vivo. The material expresses stem cell-associated proteins, including nodal, brachyury, nestin and Oct4, and has the potential to reduce inflammation and stimulate autologous intravertebral disc cells, which can lead to the repair of IVD matrix. In a spinal disc study, HST 004 reversed inflammation and protease activity and stimulated aggrecan secretion in the thrombin-induced rabbit ex vivo model. In vivo studies in the rabbit degenerative disc model showed that, in as little as 4 weeks post treatment with HST 004, disc height increased as compared to the control. MRI analysis demonstrated regeneration of the disc tissue. Pain associated with degenerative disc disease or spinal disc injury affects 21 million patients in the U.S. With surgical intervention considered a last resort and utilized in only 5% of cases, a minimally invasive treatment that helps to restore cartilage and reduce inflammation could fill a significant unmet need. On January 28, 2020, Histogen announced that it entered into a definitive agreement with Conatus Pharmaceuticals pursuant to which Histogen will merge with and into a wholly-owned subsidiary of Conatus in an all-stock transaction.

08:11 EDT Heat Biologics to present Phase 2 lung cancer trial data at ASCO - Heat Biologics (HTBX) announced that it has been selected to deliver a poster presentation at the ASCO Annual Meeting, to be held virtually during May 29-31. HS-110 is currently in Phase 2 trial in combination with Bristol-Myers Squibb's (BMY) Opdivo for multiple treatment settings in advanced non-small cell lung cancer.

08:10 EDT SurveyMonkey updates app integration with Microsoft Teams - SurveyMonkey (SVMK) announced major new features and updates to its app integration with Microsoft (MSFT) Teams. These new features make it easier for team leaders and employees to stay connected, generate surveys, and collect feedback from one another as companies across the world are working from home. Microsoft Teams has over 75 million daily active users, with SurveyMonkey app usage up more than 90% since March. The latest updates empower customers with a broad range of features for Microsoft Teams that businesses can utilize every day, including designing surveys as well as collecting, analyzing, and acting on feedback. The expanded capabilities in Microsoft Teams will improve multiple key elements of its integration and enable organizations to generate feedback directly through the Teams interface, keeping all of the data in a single place.These latest features will help make it easier for enterprises, mid-sized and small businesses to gather trends, ideas, and feedback from across their organizations to make better data-driven decisions. Users can now launch surveys and collect feedback on a number of topics, including employee check-ins on workspace environments, virtual events, employee training, and more.

08:09 EDT Cue Biopharma announces strategic research collaboration with Oxford University - Cue Biopharma announced it has entered into a research collaboration agreement with Dr. Michael Dustin and the University of Oxford to determine the molecular mechanisms underlying the activity of its IL-2 based CUE-100 series Immuno-STAT Biologics. "Cue Biopharma is pleased to enter into this strategic collaboration with Dr. Dustin and the University of Oxford," said Saso Cemerski, senior director of immuno-oncology discovery and translational immunology at Cue Biopharma. "Dr. Dustin, the scientific pioneer and founder of the T cell immune synapse field has made seminal observations contributing toward our understanding of the biophysical interactions and signaling pathways that underscore immune cell activation, including the mechanistic underpinnings of T cell recognition of antigens. Our strategic collaboration will exploit the state-of-the art technologies pioneered by Dr. Dustin's lab to elucidate the immune synapse interactions of our IL-2-based CUE-100 series that ultimately result in selective and specific activation of tumor-antigen-specific T cells."

08:06 EDT CVS Health to establish up to 1,000 COVID-19 test sites by end of May - Building on the company's comprehensive efforts to help slow the spread of the virus, on Friday, May 15 CVS Health will open more than 50 COVID-19 test sites at select CVS Pharmacy drive-thru locations across Arizona, Connecticut, Florida, Massachusetts and Pennsylvania. The opening of hundreds of additional test sites across the country will be announced over the next two weeks. The new sites will utilize self-swab tests and mark the next phase of the company's COVID-19 testing strategy, announced April 27 at the White House. CVS Health expects to have up to 1,000 locations across the country offering this service by the end of May, with the goal of processing up to 1.5M tests per month, subject to availability of supplies and lab capacity. The company currently operates large-scale rapid test sites in coordination with five states, which can process a total of nearly 30,000 tests per week. Testing will not take place inside any retail locations, and CVS Pharmacy, HealthHUB and MinuteClinic will continue to serve customers and patients.

08:05 EDT Carnival: Booking trends for 1H21 remain within historical ranges - President and CEO Arnold Donald said: "Our booking trends for the first half of 2021, which remain within historical ranges, demonstrate the resilience of our brands and the strength of our loyal recurring customer base, of which 66% are repeat cruisers. In addition, we plan to stagger fleet reentry to optimize demand and operating performance over time."

08:03 EDT Carnival announces layoffs, furloughs, reduced work weeks, salary reductions

08:02 EDT Carnival reports steps to bolster ability to manage through pause in guest ops

07:57 EDT CorVel announces improved payment process for provider portal - CorVel Corporation announced expansion of its provider portal interface, increasing payment options to ensure timely and accurate payment for healthcare providers. To ensure healthcare providers receive prompt payment for their services, CorVel offers a portal through which providers can submit bills, medical records, and be paid, overcoming barriers to slow payment or lack of electronic remittance options. The provider portal, in combination with the Company's AI-augmented claim workflow, compresses the time that it takes to process and pay medical bills. The program is gaining momentum as the use of the portal increases.

07:54 EDT Immunovant achieves first earnout milestone under share exchange agreement - Immunovant announced that holders of its 11.5 million outstanding warrants will have until 5:00 p.m., New York City time, on June 15, 2020 to exercise their warrants. The 11.5 million warrants are exercisable for an aggregate of 5.75 million shares of Immunovant's common stock at a price of $11.50 per share, representing a total of $66.125 million in potential proceeds to Immunovant. Pursuant to the warrant agreement, Immunovant is entitled to redeem all of the outstanding warrants if the last sale price of its common stock is at least $16.50 per share on each of 20 trading days within any 30 trading-day period. This share price performance target was achieved on May 11, 2020. Any warrants that remain unexercised immediately after 5:00 p.m., New York City time, on June 15, 2020 will be void and no longer exercisable, and the holders of those warrants will be entitled to receive $0.01 per warrant. Warrants must be exercised for a whole number of shares at a price of $11.50 per share and, as a result, warrants must be exercised in multiples of two. As a result of the redemption of the outstanding warrants, Immunovant's warrants and units will each cease to be listed on the Nasdaq Capital Market, effective at the close of trading on June 15, 2020. Holders of warrants in "street name" should immediately contact their broker to determine their broker's procedure for exercising their warrants since the process to exercise is voluntary. At 5:00 p.m., New York City time, on June 15, 2020, Immunovant's outstanding units will be mandatorily separated into their component parts - one share of common stock and one warrant to purchase one-half of one share of common stock - and the warrants and units will cease trading. As a result, at 5:00 p.m., New York City time, on June 15, 2020, each unit holder's account, in lieu of units, will reflect ownership of the number of shares of common stock underlying such holder's units. The shares of common stock underlying the warrants have been registered by Immunovant under the Securities Act of 1933, as amended, and are covered by a registration statement filed with, and declared effective by, the Securities and Exchange Commission. In addition to the warrant redemption, Immunovant announced that it has satisfied the criteria to issue 10 million shares of common stock to the former shareholders of Immunovant Sciences, the first earnout milestone under the Share Exchange Agreement, dated September 29, 2019, by and among Health Sciences Acquisitions Corporation, Immunovant Sciences Ltd., the Sellers and Roivant Sciences Ltd., as representative of the Sellers. The Sellers were entitled to receive an additional 10 million shares of common stock after the closing of the business combination with HSAC in December 2019 if the volume-weighted average price of the common stock was at least $17.50 per share for each of 20 trading days within any 30 trading-day period prior to March 31, 2023. This condition was met as of May 12, 2020.

07:47 EDT Emerald Health Therapeutics reduced workforce by approx. 60 employees - A strategic restructuring that occurred throughout the second half of fiscal 2019 and into the first quarter of 2020, reduced Emerald's workforce by approximately 60 employees, significantly decreasing SG&A labour costs.

07:44 EDT Orin Hirschman reports 9.43% passive stake in Energy Focus

07:40 EDT Stratasys announces actions in response to COVID-19 pandemic - In response to COVID-19, the company has taken actions to ensure employee safety, preserve liquidity, maintain business continuity, mitigate costs and support the global healthcare community to combat the pandemic. The company initiated travel restriction policies, instituted work-from-home for most employees, implemented comprehensive safety protocols for all offices. Stratasys also instituted a non-essential hiring freeze, effectively reducing all employees to a four-day work week while adjusting cost base and production plan. The company continues to invest in new product development that it believes will be the foundation of growth for many years to come. Lastly, Stratasys has worked with its global network of partners and customers to facilitate the printing of hundreds of thousands of components such as face shields, testing swabs and ventilator tubes to the global medical community.

07:37 EDT Probe Metals completes acquisition of 100% interest in Detour Quebec project - Probe Metals announced the completion of the previously announced acquisition of SOQUEM's 25% interest in the Company's Detour Quebec Joint-Venture Project. The details of the transaction and the property are described in the Company's press release dated April 27, 2020. Pursuant to the Transaction, Probe owns 100% of the Detour Quebec Project. The Company acquired SOQUEM's interest for total consideration of 599,359 common shares to SOQUEM for a total value of $425,000 based on 20-day volume weighted average price of $0.709 per share on the TSX Venture Exchange; and is subject to regulatory approval, one milestone payment of $1,000,000 if a positive Preliminary Economic Assessment is released including mineral resources of at least 1,000,000 ounces of gold. Probe would have the option to pay the milestone payment in cash, in shares of the Company or a combination of both at the sole discretion of the Company. In accordance with applicable securities regulations and the policies of the Exchange, the common shares issued to SOQUEM pursuant to the Transaction are subject to a statutory four month and a day hold period.

07:33 EDT Safehold to be added to MSCI U.S. REIT Index, effective May 29 - Safehold announced that it will be added as a constituent to the MSCI U.S. REIT Index, effective at the close of market on May 29. MSCI now recognizes Land (ground lease) as an eligible property type and Safehold has become the first and only company to be included within the new category.

07:30 EDT uniQure presents preclinical data in SCA3, Fabry Disease, Hemophilia A - uniQure presented new preclinical data on its gene therapy candidates AMT-150 for Spinocerebellar Ataxia type 3, AMT-190 for Fabry disease, and AMT-180 for the treatment of Hemophilia A. The data are featured in presentations at the American Society of Gene and Cell Therapy Annual Meeting. uniQure is delivering a total of 22 data presentations at the meeting, which is taking place virtually from May 12 to May 15. The uniQure presentations in Spinocerebellar Ataxia type 3 show a continuation of strong proof-of-concept data in mice and other preclinical models, as well as encouraging new data in non-human primates (NHPs). Additionally, new data related to AAV biology show that a single administration of AAV5-hFIX in newborn mice led to stable hFIX expression up to 18 months after dosing. SCA3, also known as Machado-Joseph disease, is caused by a CAG-repeat expansion in the ATXN3 gene that results in an abnormal form of the protein ataxin-3. People with SCA3 experience brain degeneration that results in movement disorders, rigidity, muscular atrophy and paralysis. There is currently no treatment available that slows the progressive course of this lethal disease. AMT-150 is a one-time, intracisternally-administered, AAV gene therapy incorporating the Company's proprietary miQURE silencing technology that is designed to halt ataxia in early manifest SCA3 patients. AMT-150 is currently in pre-investigational new drug enabling studies. In an in vivo preclinical study featured in an oral presentation, six non-human primates received a one-time injection of AMT-150 via the cisterna magna to assess expression and distribution. Samples taken after 8 weeks showed widespread transduction of the brain and spinal cord, with the highest genome copies found in the posterior fossa and cortical regions. ATXN3-microRNA was expressed in all brain regions and was correlated with the number of vector genome copies. Using in-situ hybridization, researchers confirmed the presence throughout the brain of high quantities of mature miATXN3 microRNA molecules. In other preclinical studies featured in separate poster presentations, researchers evaluated AMT-150 in SCA3 mouse models, as well as human induced pluripotent stem cell-derived neurons and astrocytes, to investigate potential off-target effects of AAV5-miATXN3. The iPSC-derived cell cultures, which were derived from two SCA3 patients, represent the most disease-relevant cell type for therapeutic targeting of AMT-150. A clear dose-dependent expression of miATXN3 was observed in the iPSC-derived neurons and astrocytes transduced with AMT-150. Mature miATXN3 molecules were also associated with extracellular vesicles that strongly correlated with the dose and miATXN3 expression, suggesting the potential therapeutic spread of the engineered miATXN3. Additionally, AMT-150 clearly demonstrated ATXN3 knockdown in human neurons and various SCA3 mouse models with subsequent neuropathology improvement. Fabry disease is an X-linked genetic disorder resulting from a deficiency of alpha-galactosidase A. The current standard of care for Fabry disease is bi-weekly infusions of enzyme replacement therapy, a treatment that has limited effectiveness in many patients due to poor cross-correction, which hampers clearance of substrates in the target organs, in particular the kidney and the heart. In addition, a significant number of patients develop antibodies to the enzyme, alpha-gal or GLA. AMT-190 provides expression of a proprietary, exclusively licensed modified NAGA, which shows a high structural resemblance to alpha-gal and has GLA activity. ModNAGA may have several advantages over current therapies, including higher stability in plasma, circumvention of GLA-inhibitors and better uptake in target organs. In vivo studies in wild-type NHPs were conducted to assess expression of ModNAGA upon AAV-injection. These studies demonstrated that a single administration of AMT-190 resulted in modNAGA expression in the liver and significant increases of GLA activity levels in the NHP plasma. Earlier in vivo studies in GLA knock-out and WT mice demonstrated that AMT-190 resulted in up to ten-fold higher GLA activity in plasma, compared to the relevant control group, and successful lowering of Gb3 and LysoGb3 in plasma and target organs of GLA-KO mice. The data presented also show that a single administration of AMT-190 in GLA-KO mice continued to elevate GLA-activity levels in the liver and plasma and reduce GLA-substrates in plasma and target organs up to 30-weeks post-injection. Hemophilia A is an X-linked bleeding disorder resulting from a deficiency in coagulation Factor VIII that serves as a cofactor for Factor IX in the activation of the coagulation cascade. About 30 percent of the hemophilia A patient population develops inhibitors to Factor VIII over the course of the disease. AMT-180 comprises a recombinant AAV5 vector incorporating a proprietary modified Factor IX gene. Data from multiple in vivo studies in rodents and NHPs demonstrated that a single administration of AMT-180 was well-tolerated and without increased coagulation activation markers. The preclinical studies were used to predict suitable clinical doses by assessing Factor VIII-independent clotting activity and correlating this to FIX-FIAV protein levels. The studies demonstrated that the dose calculation model in NHPs predicted dose-dependent increases in FVIII-independent activity. A Single Administration of AAV5-hFIX in Newborn, Juvenile and Adult Mice Leads to Stable hFIX Expression up to 18 Months after Dosing. In addition to updates on our preclinical programs, an oral presentation provides important new data on AAV biology, showing that AAV5/FIX expression was maintained long-term, up to 18 months after dosing, in mice that were treated very early in life. The total number of genomic transgene copies was remarkably constant during the lives of the mice. FIX expression was maintained during the 18 months after dosing, despite the cells in the liver having turned over several times. The original volume of liver that was transduced is smaller in younger mice, but the mice livers did not lose the initial transduction/expression during cell division over time.

07:27 EDT Solid Biosciences presents data from DMD Gene Therapy Program - Solid Biosciences announced the presentation of clinical biomarker data from its SGT-001 microdystrophin gene therapy clinical trial for the treatment of Duchenne muscular dystrophy on May 13 at the American Society of Gene and Cell Therapy 23rd Annual Meeting, which is being held virtually. In addition, data from studies characterizing novel adeno-associated virus vectors engineered for muscle gene delivery were presented in a poster session. SGT-001 Microdystrophin Gene Therapy for Duchenne Muscular Dystrophy. Oral presentation delivered by Patrick Gonzalez, PhD, Associate Director, R&D, Solid Biosciences. Data presented from the ongoing IGNITE DMD clinical trial studying SGT-001 at a dose of 2E14 vg/kg were: SGT-001 administration results in dose-dependent, muscle wide microdystrophin expression in muscle biopsies collected 90 days post-SGT-001 administration. SGT-001-driven microdystrophin expression results in stabilization of dystrophin associated proteins. SGT-001-driven microdystrophin expression results in restored enzymatically active neuronal nitric oxide synthase at the sarcolemma. Characterization of Novel AAV Vectors Engineered for Muscle Gene Delivery. Poster presentation and online Q&A delivered by Jennifer Green, PhD, Senior Scientist, R&D, Solid Biosciences. This study utilized a rational design approach to generate a set of novel capsids predicted to have increased muscle tropism and transduction efficiency for the development of treatment for Duchenne. Key findings are: AAV-SLB101, a novel capsid, showed superior transduction efficiency in comparison to AAV9 in in vitro assays in both mouse and Duchenne human skeletal muscle cells. These in vitro results translated to increased biodistribution and microdystrophin protein expression in vivo in both quadriceps and heart, and decreased biodistribution to liver, in comparison to AAV9. An expanded panel of novel capsids identified two more candidates of interest, AAV-SLB102 and AAV-SLB111, that look similar to AAV-SLB101 in in vitro assays for binding, uptake and microdystrophin protein expression in C2C12 cells.

07:24 EDT Sol-Gel Technologies expects data from PoC study of SGT-210 in 2021 - A proof of concept clinical study of SGT-210, erlotinib gel, a topical epidermal growth factor receptor inhibitor, for the potential treatment of punctuate palmoplantar keratoderma type 1 initiated in January 2020. This clinical study was recently expanded to include other types of palmoplantar keratoderma. Patient enrollment is expected to be renewed subject to Israel Ministry of Health guidelines for COVID-19. Data is expected in 2021.

07:23 EDT Sol-Gel Technologies to file Epsolay NDA in 2Q20 - Sol-Gel expects to file an NDA for Epsolay in the second quarter of 2020. If approved, Epsolay has the potential to be the first FDA-approved single-agent BPO prescription drug product and to redefine the standard of care for the treatment of inflammatory lesions associated with rosacea.

07:21 EDT Prevail to report interim data from Phase 1/2 trial of PR001 in 2H20 - As announced in March 2020, Prevail initiated dosing for the PROPEL Phase 1/2 trial of PR001 for patients with PD-GBA. As previously reported, in response to the COVID-19 pandemic, trial sites had temporarily suspended patient screening and enrollment activity. Prevail now expects patient screening to resume by the end of the second quarter of 2020 at certain clinical sites. The Company remains on track to report interim data on a subset of patients in the second half of 2020. In addition, study startup activities are continuing for the PROVIDE Phase 1/2 clinical trial of PR001 for Type 2 nGD, and the Company intends to initiate dosing in mid-2020. Prevail also continues to expect to initiate the PROGRESS Phase 1/2 clinical trial of PR001 for Type 3 nGD in the second half of 2020. The timelines for PR001 are subject to any delays related to the COVID-19 pandemic.

07:19 EDT Frequency Therapeutics announces data from FX-322 exploratory clinical study - Frequency Therapeutics announced top-line data from an exploratory clinical study designed to show whether drug levels of FX-322 in the cochlea can be directly measured. In addition to confirming the viability of the approach, study results showed measurable concentrations of FX-322 in every patient and that anatomical factors did not prevent the active agents of FX-322 from reaching the cochlea. Further, the levels of FX-322 in the cochlea were predicted to reach the therapeutically active range of the treatment. FX-322 is Frequency's lead product candidate, designed to regenerate auditory sensory hair cells in the cochlea and improve hearing in patients with sensorineural hearing loss, or SNHL. A Phase 1/2 study of FX-322 previously demonstrated statistically significant and clinically meaningful improvements in key measures of hearing function in patients with SNHL. The exploratory study, initiated late in 2019, was conducted at the Hannover Medical Centre in Hannover, Germany. Results were based on an analysis of cochlear fluid, known as perilymph, obtained intraoperatively from patients undergoing cochlear implant surgery. Each patient received a single intratympanic injection of FX-322, enabling researchers to directly measure the level of FX-322 in perilymph, which is not otherwise feasible in inner-ear studies because accessing the cochlea involves an invasive surgical procedure. In the study, seven subjects received a single dose of FX-322 at the same dose level given in the company's Phase 1/2 study and its ongoing Phase 2a study. Levels of both molecules that make up FX-322 were measured in all patients. The presence of round window membrane mucosal folds in certain subjects did not prevent the entry of FX-322 into the cochlea. Both agents that make up FX-322 were also predicted to achieve therapeutically active drug levels in the high frequency range of the cochlea, based on computer models. Study subjects were followed for approximately 30 days after the procedure and no serious treatment related adverse events were observed.

07:15 EDT Hookipa Pharma says on track to file HB-202 initial new drug submission in 1H20 - HOOKIPA's lead oncology product candidates, HB-201 and HB-202, are in development for the treatment of Human Papillomavirus-positive cancers. In December 2019, HOOKIPA initiated the Phase 1/2 clinical trial for HB-201 and expects preliminary results in late 2020 or early 2021. The open label, dose escalating Phase 1/2 clinical trial is evaluating HB-201 in HPV16+ cancers, alone and in combination with an approved checkpoint inhibitor. HOOKIPA plans to enroll 100 patients in total with 20 patients in each dose escalation and expansion group, respectively. Enrollment of the first group of patients receiving the intravenously administered first dose level has been completed and the trial is accruing patients at the next higher dose level. HOOKIPA remains on track to file the HB-202/201 Initial New Drug submission with the U.S. Food and Drug Administration in the first half of 2020. The planned clinical trial combining HB-202 with HB-201, also in patients with HPV16+ cancers, is an open label, dose escalation Phase 1/2 trial with the primary endpoint to evaluate safety and tolerability. That trial is expected to commence later in 2020.

07:14 EDT Nevro announces CE mark approval for the Senza Omnia SCS system - Nevro announced it has received CE mark approval for the Senza Omnia Spinal Cord Stimulation system. "Following a successful launch in the United States late last year, we are excited to now have approval for the Senza Omnia SCS system in Europe," said D. Keith Grossman, Chairman, CEO and President of Nevro.

07:11 EDT VBL Therapeutics expects cash to fund requirements into 3Q22 - At March 31, 2020, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposits totaling $31.6 million and working capital of $24.6 million. VBL expects that its cash and cash equivalents and short-term bank deposits with the addition approximately $16.7 million from the net proceeds of the Registered Direct Offerings of which we have announced on May 7, 2020 and on May 11, 2020, will be sufficient to fund operating expenses and capital expenditure requirements into the third quarter of 2022.

07:07 EDT Gan Limited reports April internet gaming win up 118.6% year-over-year - Gan Limited updated the market following the publication on May 13 by New Jersey's Division of Gaming Enforcement, or DGE, of Internet gaming and Internet sports betting financial information for the calendar month of April in New Jersey. Internet Gaming Win was $80M in April, compared to $36.6M in the prior year period, reflecting a year-over-year increase of 118.6%. Total Internet Sports Wagering Handle was approximately $54.6M for the month of April, a significant decrease from prior months as the result of most sporting events being canceled during the global COVID-19 pandemic, which compares to: $163.4M for the month of March, $436.5M for the month of February and $471.1M for the month of January. Internet Sports Wagering Gross Revenues for the month of April were $2.7M, compared to $16.6M in April 2019.

07:06 EDT Norwegian Cruise Line sees approx $70M-$110M per month costs during suspension - The company said, "The Company has taken swift, proactive measures to mitigate the financial and operational impacts of COVID-19. This action plan includes cost reduction and cash conservation levers the Company has deployed to preserve and enhance liquidity while also securing additional capital. The Company anticipates estimated ongoing ship operating expenses and administrative operating costs combined to range from approximately $70 million to $110 million per month during the suspension of operations as a result of the following cost reduction measures: Meaningfully reducing cruise operating expense which includes reducing expenses associated with crew payroll, food, fuel, insurance and port charges. The majority of ships in the Company's fleet are currently transitioning to cold layup. Significantly reduced or deferred marketing expense in the first half of the year. Introduced a temporary shortened work week and reduced work hours with commensurate 20% salary reduction for shoreside team members. Temporarily furloughed approximately 20% of the shoreside workforce through July 31, 2020. Furloughed team members remain employees of the Company and retain healthcare and other benefits. The Company is covering the employee share of medical insurance premiums during the furlough period. Implemented a company-wide hiring freeze. Paused employer 401(k) match contribution. Suspended travel for shoreside employees across the organization. Reduced Capital Expenditures: The Company has identified approximately $515 million of capital expenditure reductions, comprised of: Approximately $345 million, or an approximately 65% reduction of non-newbuild capital expenditures for the remainder of 2020. Approximately $170 million in expected deferred capital expenditures for newbuild related payments through March 31, 2021. The Company is currently finalizing documentation for deferrals of these payments. Upon completion, the Company does not expect any newbuild related payments to have an impact on liquidity until April 2021. Total capital expenditures, net of expected deferrals of newbuild related payments, for the remainder of 2020 is expected to be approximately $195 million. Improved Debt Maturity Profile: Deferred approximately $385 million of payments related to guaranteed financing by Euler Hermes Aktiengesellschaft, the official Export Credit Agency ("ECA") of Germany, through April 2021 and amended associated credit agreements to incorporate this debt deferral in connection with an industrywide initiative granting a 12-month debt holiday to provide interim debt service relief for amortization payments and financial covenants. The Company is finalizing documentation for the deferral of the remaining approximately $155 million of ECA backed payments through March 31, 2021 with its other ECA lenders. Deferrals are to be repaid in eight equal semi-annual installments following the Debt Holiday. Secured a 12-month deferral for approximately $150 million of debt amortization through March 31, 2021 relating to the Term Loan A and Norwegian Jewel term loan. Deferrals are to be repaid 25% per year in equal installments following the deferral period with any outstanding balance paid in full at maturity. Extended $230 million Pride of America term loan by one year to January 2022. Extended $675 million Norwegian Epic revolving credit facility to March 2022. Taken together, the aforementioned cash conservation measures and the deferral of near-term debt amortization and newbuild related payments, the Company estimates its monthly cash burn to be on average in the range of, approximately $120 million to $160 million per month during the suspension of operations. This includes ongoing ship operating expenses, administrative operating expenses, interest expense (including approximately $12 million of additional cash interest expense per month for the next twelve months for debt refinancings and new financing transactions announced last week) and expected capital expenditures and excludes cash refunds of customer deposits as well as cash inflows from new and existing bookings. The increase versus prior monthly cash burn estimates of approximately $110 million to $150 million per month reflects additional interest expense."

07:03 EDT Carlyle Group portfolio company acquires Tissue Analytics - Net Health, a portfolio company of Carlyle Group, announced that it has acquired Tissue Analytics, a developer of automated mobile wound and skin imaging and predictive analytics solutions. The acquisition of Tissue Analytics expands Net Health's position within the wound care market, and for all customers, will accelerate the delivery of next generation wound care technology solutions, including predictive analytics. Silversmith invested additional equity to support the acquisition of Tissue Analytics.Tissue Analytics applications will be integrated with Net Health's WoundExpert EHR solution to add capabilities for use within hospital outpatient settings. Clinicians will be able to capture and upload wound images and other documentation, including automated measurements, to the WoundExpert platform. All Tissue Analytics employees have joined Net Health, with co-founder Kevin Keenahan and CTO Joshua Budman taking on leadership roles in business development and predictive analytics, respectively. The company's SMART on FHIR workflows will continue to be made available for all EHR partners and health systems.

06:52 EDT Intelsat trading halted, news dissemination

06:39 EDT Kaleido Biosciences begins clinical study of KB109 in COVID-19 patients - Kaleido Biosciences initiated a controlled clinical study evaluating Microbiome Metabolic Therapy candidate KB109 added to Supportive Self-Care for outpatients who are positive for SARs-Cov-2 infection with mild-to-moderate COVID-19. "The burden of the COVID-19 pandemic on patients and healthcare facilities is vast, and there remains a need for interventional studies evaluating patients with mild-to-moderate disease, which represents the majority of infections," said Chief Medical Officer and Head of Research & Development Katharine Knobil. "We have evidence from our ex vivo research that KB109 increases the production of metabolites that have been shown to improve the immune response in viral respiratory infections. Published data suggest these metabolites may prevent an overaggressive immune response to COVID-19 and avoid more serious complications of this infection. Because of the favorable safety profile of KB109, we are able to rapidly initiate this very important clinical study. We look forward to exploring the potential of KB109 in COVID-19 as well as expanding our understanding of its applicability to other infections." The studies will include assessment of clinical outcomes, healthcare utilization, and biomarkers of the inflammatory response that will inform the potential of KB109 in COVID-19 as well as other viral and bacterial infections. Top-line data from the multi-center study are expected in Q4.

06:14 EDT Exact Sciences announces results from Oncotype DX clinical survey at ASCO - Exact Sciences announced results from a prospective clinical survey of the Oncotype DX Breast Recurrence Score test, accepted at the 2020 American Society of Clinical Oncology, or ASCO, annual meeting, published online in the ASCO meeting library, and expected to be published in the Journal of Clinical Oncology meeting's proceedings. The findings, consistent with previous studies, further support the value of the test in guiding chemotherapy treatment decisions. Results also highlight the practice-changing impact of the landmark TAILORx study, which showed that the Oncotype DX test identifies the vast majority of women with node-negative disease who receive no substantial benefit from chemotherapy, as well as the important minority for whom chemotherapy can be life-saving. The survey results at ASCO20 summarize physicians' treatment decisions pre- and post-Recurrence Score results in hospitals across Latin America. A total of 647 patients were enrolled during routine care at 14 community and academic sites in Argentina, Colombia, Mexico, and Peru, while an additional 155 patients were treated at the largest public breast cancer hospital in Brazil. The analysis conducted in Argentina, Colombia, Mexico, and Peru included patients treated before and after the June 2018 publication of TAILORx. Overall, the findings revealed a 36% net decrease in chemotherapy recommendations among patients with node-negative disease and a 46% decrease in those with node-positive disease. Importantly, the decrease in chemotherapy recommendations in node-negative disease was greater following the publication of TAILORx results and went from 28% to 36%. Of the 155 patients treated in Brazil between August 2018 and April 2019, 70% were classified as having high-risk disease based on traditional clinical parameters, and the majority had tumors larger than two centimeters. A total of 151 of the 155 patients were initially recommended chemotherapy in addition to hormonal therapy based on clinical and pathological features. Based on their Recurrence Score results, 104 of the 151 patients were spared chemotherapy and received hormonal therapy alone instead. Results from this public hospital show that clinical and pathological features did not adequately identify patients most likely to benefit from chemotherapy. Testing also led to economic benefits and potential savings, suggesting that the Oncotype DX test should be incorporated in the Brazilian public health system.

06:05 EDT Organigram announces first phase of return-to-work strategy - Organigram Holdings has announced the first phase of its return-to-work strategy. The company has begun to implement a staggered return-to-work plan effective May 13. While the Province of New Brunswick currently remains in a state of emergency, the company has been in contact with government officials to stay abreast of the province's and provincial health authority's guidance related to safety and security. Indications suggest conditions in New Brunswick continue to improve and the province may begin to lift some of the current restrictions. Similarly, Organigram has maintained an open dialogue with jurisdictional and regional partners across the country through the pandemic in order to assess and appropriately respond to consumer demand. The first phase of Organigram's return-to-work strategy involves recalling approximately 50 employees at the Moncton campus. These employees will fill core roles across various departments that have been deemed highest priority by the Organigram leadership team in this initial phase. Subsequent phases of this plan will be dependent upon public health and safety guidelines and the evolving needs of Organigram's business. The safety of employees remains Organigram's top priority. Safety measures including an increased focus on sanitation and social distancing, with additional hand sanitizing stations throughout the facility, cleaning and sanitizing of high touch surfaces, and additional cleaning in common areas implemented at the outset of the pandemic remain in place at the Organigram facility. The company's leadership team will continue to monitor measures and requirements as mandated by the Province of New Brunswick to ensure a safe and healthy workplace for all employees.

05:32 EDT Xeris Pharmaceuticals enters exclusive agreement with Clinigen Group - Xeris Pharmaceuticals announced an exclusive agreement with Clinigen Group to manage the supply and distribution of Gvoke outside of the United States where Gvoke is not currently licensed.

05:18 EDT Sanofi announces FDA priority review of sutimlimab - The FDA has granted priority review of Sanofi's Biologics License Application, or BLA, for sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease, or CAD. Sutimlimab, an investigational monoclonal antibody, targets the underlying cause of hemolysis in CAD by selectively inhibiting complement C1s. If approved, sutimlimab would be the first and only approved treatment for these patients. The target action date for the FDA decision is November 13. "People living with cold agglutinin disease currently have no approved treatment option and experience chronic anemia and profound fatigue, which have a persistent and serious impact on their lives," said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi. "Results from our 26-week pivotal Phase 3 study clearly demonstrated that sutimlimab had a clinically meaningful effect on complement-mediated hemolysis, which is the cause of anemia and fatigue. If approved, sutimlimab will be the first and only FDA-approved treatment to uniquely address C1-activated hemolysis and help alleviate the chronic disease burden for people with CAD."

05:12 EDT Intelsat, certain subsidiaries file voluntary Chapter 11 petitions - Intelsat announced that it has undertaken a financial restructuring to position the company for long-term success. The restructuring process is intended to enhance the Company's liquidity and will likely result in a substantial reduction of Intelsat's legacy debt burden, allowing for Intelsat to emerge with a strengthened balance sheet to complement its strong operating model and future growth plans. One of the primary catalysts for restructuring the balance sheet now is Intelsat's desire to participate in the accelerated clearing of C-band spectrum under the Federal Communications Commission order in support of a build-out of 5G wireless infrastructure in the United States. To meet the FCC's accelerated clearing deadlines and ultimately be eligible to receive $4.87B of accelerated relocation payments, Intelsat needs to spend more than $1B on clearing activities. These clearing activities must start immediately, long before costs begin to be reimbursed. The company is also managing the economic slowdown impacting several of its end markets caused by the COVID-19 global health crisis. "This is a transformational moment in the history of our company," said Stephen Spengler, CEO of Intelsat. "Intelsat is the pioneer and foundational architect of the satellite industry. For more than 50 years, we have been respected for quality, innovation, sector leadership, and premium services. Our success has come despite being burdened in recent years by substantial legacy debt. Now is the time to change that. We intend to move forward with the accelerated clearing of C-band spectrum in the United States and to achieve a comprehensive solution that would result in a stronger balance sheet. This will position us to invest and pursue our strategic growth objectives, build on our strengths, and serve the mission-critical needs of our customers with additional resources and wind in our sails." To facilitate the financial restructuring, Intelsat and certain of its subsidiaries have filed voluntary Chapter 11 petitions in the U.S. Bankruptcy Court for the Eastern District of Virginia, Richmond Division. Intelsat General, or IGC, which serves the Company's U.S. commercial, government, and Allied military customers, is not part of the Chapter 11 proceedings. While it moves as quickly as possible through the restructuring process, Intelsat's day-to-day operations, engagement with customers and partners, and capital investments will continue as usual. The company will continue to drive its business forward - launching new satellites, investing in its ground networks, developing new services, and progressing Intelsat's next generation network and service strategy at full speed. No changes to the company's operations or workforce are planned. Intelsat has secured a commitment for $1 billion of new financing. Subject to Court approval, this debtor-in-possession financing, coupled with significant cash on hand and positive cash flow generated by the business, will provide ample liquidity during the restructuring process to support ongoing operations, fund the substantial upfront C-band clearing costs, and allow the company to continue investing in the innovations and services that customers need today and in the future. The company is filing with the Court a series of customary motions seeking to maintain business-as-usual operations and uphold its commitments to its stakeholders, including employees, customers, and vendors, during the restructuring process. Approval of these "first day" motions, which the Company expects to receive in short order, will help facilitate a smooth transition into the process.