Stockwinners Market Radar for May 15, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:17 EDT J C Penney trading halted, news dissemination

18:38 EDT Deciphera announces FDA approval of QINLOCK for treatment of GIST - Deciphera announced the U.S. FDA has approved QINLOCK for the treatment of adult patients with advanced gastrointestinal stromal tumor who have received prior treatment with 3 or more kinase inhibitors, including imatinib. The FDA previously granted Breakthrough Therapy and Fast Track designations as well as Priority Review for QINLOCK and reviewed the New Drug Application under the Real-Time Oncology Review pilot program. The QINLOCK NDA is also part of Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among participating international health authorities. QINLOCK targets the broad spectrum of KIT and PDGFR alpha mutations known to drive GIST.

18:28 EDT J.C. Penney files for Chapter 11 Bankruptcy, secures $900M in DIP financing - J. C. Penney announced that it has entered into a restructuring support agreement with lenders holding approximately 70% of JCPenney's first lien debt to reduce the company's outstanding indebtedness and strengthen its financial position. The RSA contemplates agreed-upon terms for a pre-arranged financial restructuring plan that is expected to reduce several billion dollars of indebtedness, provide increased financial flexibility to help navigate through the Coronavirus pandemic, and better position JCPenney for the long-term. To implement the Plan, the company filed voluntary petitions for reorganization under Chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court for the Southern District of Texas, in Corpus Christi, TX. During this process, JCPenney will continue to be one of the nation's largest apparel and home retailers with an expansive footprint of hundreds of stores across the U.S. and Puerto Rico and a powerful eCommerce site, jcp.com. JCPenney is welcoming customers back to select stores and continuing to offer its Contact-free curbside pickup service at all open stores. At the same time, JCPenney's eCommerce distribution centers continue to fulfill online orders and customer care centers are answering inquiries as usual. The health and safety of associates, customers, and communities remains a top priority, and the company is gradually reopening stores and offices in a phased approach while following guidance from local and state orders. JCPenney has approximately $500M in cash on hand as of the Chapter 11 filing date. JCPenney has received commitments for $900M in debtor-in-possession financing from its existing first lien lenders, which includes $450M of new money. Following Court approval, this financing, combined with cash flow generated by the company's ongoing operations, is expected to be sufficient to meet JCPenney's operational and restructuring needs. As part of the DIP commitment from its existing lenders, JCPenney will explore additional opportunities to maximize value, including a third-party sale process. JCPenney will file a number of customary first day motions with the U.S. Bankruptcy Court seeking authorization to support its operations during the financial restructuring process, including authority to pay non-furloughed associate wages, provide certain benefits to all associates, and to pay vendor partners in the ordinary course for all goods and services provided on or after the Chapter 11 filing date. Implementing the financial restructuring will allow JCPenney to accelerate its store optimization strategy. As part of its ongoing transformation, JCPenney will reduce its store footprint to better align its business with the current operating environment. Stores will close in phases throughout the Chapter 11 process, and the first phase of closures, including specific store details and timing, will be disclosed in the coming weeks.

17:58 EDT Illinois American Water acquires Village of Shiloh wastewater system - Illinois American Water President Justin Ladner announced the company's acquisition of the Village of Shiloh wastewater system. The purchase adds approximately 1,515 wastewater customers to the company's southern Illinois service area. This includes customers directly served by Illinois American Water as well as customers served through a mobile home park account. The Village of Shiloh voted in favor of the sale last year. The Illinois Commerce Commission recently approved the sale for $3.6M. The sale was completed today and represents the third acquisition by Illinois American Water this year. Illinois American Water plans to invest in the Village of Shiloh wastewater system. Work will include improvements to both the Church and Archview lift stations.

17:43 EDT Deciphera up over 5% after receiving FDA approval for ripretinib in 4L+GIST

17:33 EDT Naked Brand Group gets Nasdaq non-compliance notice - Naked Brand Group has received a letter from the Listing Qualifications Department of The Nasdaq Capital Market notifying the company that its stockholders' equity was below $2.5 million, and that the company therefore did not meet the minimum stockholders' equity required for continued listing under the equity standard pursuant to Listing Rule 5550(b)(1). Because the company also does not meet the alternative standards for market value of listed securities or net income, the company no longer complies with Nasdaq's continued listing standards. The company has a period of 45 calendar days, until June 29th, 2020, to submit a plan to regain compliance.

17:19 EDT BAE Systems awarded $1.12B Defense Logistics Agency contract modification - BAE Systems has been awarded a maximum $1.12B modification exercising the five-year option period of a 10-year base contract with one five-year option period for consumable and depot-level repairables supporting multiple weapon systems platforms. This is a firm-fixed-price requirements prospective price redetermination contract. Work has a March 22, 2025, performance completion date. Using customers are Army, Navy, Air Force, Marine Corps, Defense Logistics Agency and federal civilian agencies. Type of appropriation is FY20 through 2025 defense working capital funds. The contracting activity is the Defense Logistics Agency.

17:08 EDT ChannelAdvisor's Wingo sells 55,000 common shares - In a regulatory filing, ChannelAdvisor director M. Scot Wingo disclosed the sale of 55,000 common shares of the company on May 15 at a price of $12.39 per share.

17:01 EDT Berkshire exits Travelers, boosts stakes in United and Delta in Q1 - Warren Buffett's Berkshire Hathaway (BRK.A, BRK.B) disclosed in an SEC filing its holdings as of March 31, 2020. The fund exited two positions during the first quarter, including by size of previous position Travelers (TRV) and Phillips 66 (PSX). Berkshire increased its stake in three holdings, including by size of previous position PNC Financial (PNC), United Airlines (UAL), and Delta Air Lines (DAL). The fund reduced its stake in 17 holdings, including by size of previous position JPMorgan (JPM), Goldman Sachs (GS), General Motors (GM), Southwest (LUV), and American Airlines (AAL). Berkshire's top holdings as of March 31, in order of size, were Apple (AAPL), Bank of America (BAC), Coca-Cola (KO), American Express (AXP), and Wells Fargo (WFC).

16:50 EDT Third Point adds Disney, exits Campbell Soup in Q1 - Third Point disclosed in an SEC filing its holdings as of March 31, 2020. The fund's seven new buys during the first quarter included, by size of position, Disney (DIS), Charter Communications (CHTR), Roper Technologies (ROP), TE Connectivity (TEL), and ServiceMaster Global (SERV). Third Point exited 13 positions during the quarter, including by size of previous position Campbell Soup (CPB), Boston Scientific (BSX), Fox Corp. Class A (FOXA), Five Below (FIVE), and TD Ameritrade (AMTD). The fund increased its stake in five holdings, including Amazon (AMZN), Centene (CNC), and Ferrari (RACE). Third Point reduced its stake in 12 holdings, including by size of previous position Baxter (BAX), Raytheon Technologies (RTN), Burlington Stores (BURL), Salesforce (CRM), and Iqvia (IQV). The fund's top holdings as of March 31, in order of size, were Baxter, Danaher (DHR), Amazon, Centene, and Fidelity National Information Services (FIS).

16:43 EDT Pareteum discloses Nasdaq delinquency notice - Pareteum announced that on May 12, the company received a determination letter from the Listing Qualifications Staff of The Nasdaq Stock Market LLC indicating that the company is not in compliance with the requirement that a listed company timely file all required periodic financial reports with the Securities and Exchange Commission to remain listed on On May 13, 2020, the company received an additional letter from Nasdaq indicating that as a result of the company's failure to file a Quarterly Report on Form 10-Q for its fiscal period ended March 31, 2020, it was in further violation of the Rule. The company intends to timely request a hearing before the Nasdaq Hearings Panel. Under Nasdaq's rules, a timely request will stay the delisting of the company's securities pending the Panel's decision for a period of 15 days from the date of the request. During this process, assuming the Panel agrees to stay the suspension of trading beyond an automatic fifteen day stay, the company's common stock will continue to trade on The Nasdaq Capital Market until the Panel issues its decision following the hearing and through the expiration of any additional extension period granted by the Panel.

16:37 EDT Paulson adds Kirkland Lake, exits Caesars in Q1 - John Paulson's Paulson & Co. disclosed in an SEC filing its holdings as of March 31, 2020. The fund's two new buys during the first quarter included, by size of position, Kirkland Lake (KL) and Navistar (NAV). Paulson exited six holdings during the quarter, including by size of previous position Agnico Eagle Mines (AEM), Caesars (CZR), and LogMeIn (LOGM). The fund increased its stake in five holdings, including by size of previous position Tiffany (TIF), Tech Data (TECD), QEP Resources (QEP), Endo (ENDP), and Novagold (NG). Paulson reduced its stake in nine holdings, including by size of previous position SPDR Gold Shares (GLD), Discovery (DISCA), AngloGold Ashanti (AU), Tim Participacoes (TSU), and Pretium Resources (PVG). The fund's top holdings as of March 31, in order of size, were Bausch Health (BHC), SPDR Gold Shares, Horizon Therapeutics (HZNP), Takeda Pharmaceutical (TAK), and AngloGold Ashanti.

16:33 EDT Dril-Quip promotes Jeffrey Bird to COO, Raj Kumar to CFO - Dril-Quip announced the promotions of Jeffrey Bird to president and COO and Raj Kumar to VP and CFO, effective immediately. Bird has served as Dril-Quip's senior VP - production operations and CFO since February 2019, prior to which he was VP and CFO since he joined the company in March 2017. Kumar has served as Dril-Quip's VP - finance and CAO since February 2019, prior to which he was VP and treasurer since he joined the company in June 2017.

16:23 EDT Icahn takes stake in Delek, adds to Occidental, Welbilt, Hertz positions - Carl Icahn disclosed in an SEC filing its holdings as of March 31, 2020. Icahn's one new buy during the first quarter was Delek US Holdings (DK). Icahn increased its stake in five holdings, including by size of previous position, Occidental Petroleum (OXY), Welbilt (WBT), Newell Brands (NWL), Hertz Global Holdings (HTZ), and Cheniere Energy (LNG). Icahn's top holdings as of March 31, in order of size, were Icahn Enterprises (IEP), CVR Energy (CVI), Herbalife (HLF), and Occidental.

16:19 EDT Wabco, ZF receive regulatory approval in China for proposed merger - WABCO Holdings and ZF Friedrichshafen announced that the Chinese State Administration for Market Regulation provided regulatory clearance for their previously announced merger. All required regulatory approvals have now been received and WABCO and ZF expect to close the merger on May 29, 2020, subject to the satisfaction of all other closing conditions.

16:16 EDT Lone Pine buys Visa, exits Salesforce in Q1 - Stephen Mandel's Lone Pine Capital discosed in an SEC filing its holdings as of March 31, 2020. Lone Pine's nine new buys during the first quarter included, by size of position, Visa (V), L Brands (LB), Howmet Aerospace (HWM), Hilton Worldwide (HLT), and Ceridian HCM (CDAY). The fund exited 12 holdings during the quarter, including by size of previous position Salesforce (CRM), Union Pacific (UNP), MercadoLibre (MELI), Domino's Pizza (DPZ), and Iqvia (IQV). Lone Pine increased its stake in 17 holdings, including by sizze of previous position Match Group (MTCH), Carvana (CVNA), Amazon (AMZN), PayPal (PYPL), and Humana (HUM). The fund reduced its stake in 12 holdings, including by size of previous position TransDigm (TDG), Sea Ltd. (SE), Square (SQ), MasterCard (MA), and Altassian (TEAM). The fund's top holdings as of March 31, 2020, in order of size, were Alibaba (BABA), UnitedHealth (UNH), Amazon, Microsoft (MSFT), and Netflix (NFLX).

16:15 EDT Appaloosa buys Twitter, Netflix stakes, exits Caesars, cuts Facebook position - David Tepper's Appaloosa Management disclosed in an SEC filing its holdings as of March 31, 2020. Appaloosa's 13 new buys during the first quarter included, by size of position, Twitter (TWTR), Netflix (NFLX), Qualcomm (QCOM), HCA Healthcare (HCA), and Tesla (TSLA). Appaloosa exited four positions during the quarter, including by size of previous position, Caesars Entertainment (CZR), Cheniere Energy (LNG), Clearway Energy (CWEN), and Clearway Energy Class A (CWEN.A). Appaloosa increased its stake in four holdings, including by size of previous position, T-Mobile (TMUS), Intelsat (I), Micron (MU), and Energy Transfer LP (ET). Appaloosa reduced its stake in 13 holdings, including by size of previous position, Facebook (FB), Alphabet Class C (GOOG), PG&E (PCG), Alibaba (BABA), and Amazon (AMZN). Appaloosa's top holdings as of March 31, in order of size, were Amazon, Alibaba, Alphabet Class C, Facebook, and Micron.

16:07 EDT Hallmark Financial receives Nasdaq notice over failure to file Form 10-Q - Hallmark Financial Services announced that it received notice from Nasdaq on May 13, 2020 that, as a result of the Company's failure to timely file its Form 10-Q for the period ended March 31, 2020 and because it remains delinquent in filing its Form 10-K for the year ended December 31, 2019, the Company is not in compliance with Nasdaq's Listing Rule 5250(c)(1). As a result, the Company has until May 28, 2020 to submit an update to its original plan to regain compliance with the filing requirements. If such updated plan is accepted, Nasdaq may grant an extension until up to September 14, 2020, to regain compliance. The notice from Nasdaq has no immediate effect on the listing of the Company's common stock on the Nasdaq Global Market. The Company intends to timely submit a plan to regain compliance with Nasdaq's listing rules and to work diligently to regain compliance with such listing rules within any extension period granted by Nasdaq. However, there can be no assurance that Nasdaq will accept the Company's plan to regain compliance or that the Company will be able to regain compliance within any extension period granted by Nasdaq. If the Company fails to timely regain compliance with Nasdaq's listing rules, the common stock of the Company will be subject to delisting on the Nasdaq Global Market.

15:58 EDT Bristol-Myers reports FDA approval for fifth indication for Opdivo + Yervoy - Bristol Myers Squibb announced that Opdivo 3 mg/kg plus Yervoy 1 mg/kg was approved by the U.S. Food and Drug Administration for the first-line treatment of adult patients with metastatic non-small cell lung cancer whose tumors express PD-L1 as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, marking the fifth indication for Opdivo + Yervoy, which is the first and only FDA-approved dual immunotherapy. "Opdivo ushered in a new era that changed the way NSCLC is treated when in 2015 it became the first immunotherapy approved for use in previously treated patients. As the first dual immunotherapy approved in the first-line setting, Opdivo + Yervoy builds on this legacy and is a testament to our commitment to helping patients with metastatic lung cancer to live longer," said Chris Boerner, chief commercialization officer, Bristol Myers Squibb.

15:46 EDT FDA approves Deciphera's fourth-line treatment of advanced GIST - The U.S. Food and Drug Administration approved Qinlock tablets as the first new drug specifically approved as a fourth-line treatment for advanced gastrointestinal stromal tumor, or GIST, a type of tumor that originates in the gastrointestinal tract. Qinlock is indicated for adult patients who have received prior treatment with three or more kinase inhibitor therapies, including imatinib. "Despite the progress that has been made over the past 20 years in developing treatments for GIST, including four FDA-approved targeted therapies - imatinib in 2002, sunitinib in 2006, regorafenib in 2013 and avapritinib earlier this year - some patients don't respond to treatment and their tumors continues to progress. Today's approval provides a new treatment option for patients who have exhausted all FDA-approved therapies for GIST," said Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research. FDA collaborated with the Australian Therapeutic Goods Administration and Health Canada on the review of this application as part of Project Orbis. FDA approved Qinlock three months ahead of schedule. The review of the applications is ongoing for the Australian TGA and Health Canada. The FDA granted approval of Qinlock to Deciphera Pharmaceuticals.

15:33 EDT Starboard Value reports 2.62M share Resideo stake

15:21 EDT Equinox Gold reports Q1 gold production 89.0K oz vs. 80.2K in Q4 - Reports Q1 gold sales 82.6K oz vs. 80.3K in Q4. The company states: "Equinox Gold took early precautionary measures at its mine sites and offices to proactively manage issues related to the COVID-19 pandemic. Each of the Company's operations has implemented preventive measures in collaboration with the Company's employees, contractors, local communities and governments to help ensure the health, safety and economic wellbeing of the Company's workforce and local communities. The Company has also evaluated supply chain and other risks at each operation and implemented business continuity protocols so the mines can operate as effectively as possible. The Company's operations have experienced limited disruption to date, with the exception of the Company's Los Filos mine in Mexico at which mining and development activities were suspended at the beginning of April in compliance with a Mexico Federal Government order requiring the temporary suspension of all non-essential businesses. On May 14th the Mexico Federal Government declared mining an essential activity and allowed for the restart of operations on June 1st. The Company is preparing to safely resume operations."

14:36 EDT Broad Street Realty collected 53% of contractual rent due for May - Broad Street Realty provided an update on the impact of COVID-19 on its business. It said in a statement, "Early on during this pandemic, the Company established a temporary COVID-19 impact response team to be proactive and anticipate issues arising as a result of the pandemic. The Company has worked hard to maintain an open line of communication with its tenants and offer assistance where possible, including helping them identify local, state and federal resources that may be available to support their businesses and employees. The Company has had a number of tenants request various forms of rent relief, which the Company is evaluating on a case-by-case basis. As of May 14, 2020, the Company had collected 70% of contractual rent due for the month of April and 53% of contractual rent due for the month of May, and the Company had agreed to defer 20% of contractual rent due for the month of April and 23% of contractual rent due for the month of May. Collections and rent deferrals to date may not be indicative of collections or rent deferrals in any future period." CEO Michael Jacoby added, "The impact of COVID-19 is real and significant. The pandemic has caused interruptions and slowdowns in our and our tenants' businesses, as well as our ability to complete the seven pending mergers with Broad Street entities."

14:31 EDT Clovis says FDA approves Rubraca tablets for BRCA mutation-associated mCRPC - Clovis Oncology announced that the U.S. Food and Drug Administration approved Rubraca tablets for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. The FDA approved this indication under accelerated approval based on objective response rate and duration of response data from the multi-center, single arm TRITON2 clinical trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The TRITON3 clinical trial is expected to serve as the confirmatory study for the Rubraca accelerated approval in mCRPC. Warning and precautions include myelodysplastic syndrome, acute myeloid leukemia and embryo-fetal toxicity. "Standard treatment options for men with mCRPC have been limited to androgen receptor-targeting therapies, taxane chemotherapy, Radium-223 and sipuleucel-T," said Wassim Abida, M.D., Medical Oncologist, Memorial Sloan Kettering Cancer Center, and Principal Investigator for the TRITON2 study. "Rubraca is the first in a class of drugs to become newly available to patients with mCRPC who harbor a deleterious BRCA mutation. Given the level and duration of responses observed with Rubraca in men with mCRPC and these mutations, it represents an important and timely new treatment option for this patient population."

14:23 EDT FDA approves Bristol-Myers combo for metastatic non-small cell lung cancer - The Food and Drug Administration today approved the combination of Bristol-Myers' Opdivo plus Yervoy as first-line treatment for patients with metastatic non-small cell lung cancer whose tumors express PD-L1, as determined by an FDA-approved test, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations. The recommended doses for metastatic NSCLC are nivolumab 3 mg/kg every two weeks and ipilimumab 1 mg/kg every six weeks until disease progression, unacceptable toxicity, or up to two years in patients without disease progression.

14:15 EDT PG&E rallies 2% to $11.34 after judge refuses to toss out victim bankruptcy vote

13:32 EDT Medtronic presents results from two late-breaking trials at SCAI sessions - Medtronic announced results from two late-breaking clinical trials presented virtually at the 2020 Society for Cardiovascular Angiography and Interventions, or SCAI, Scientific Sessions. "Ten-year outcomes from the Melody Transcatheter Pulmonary Valve Therapy demonstrated strong long-term hemodynamic and safety outcomes, while the first-ever results from the investigational Harmony TPV pivotal trial met safety and efficacy endpoints for hemodynamic function at six months," the company stated. "As demonstrated by these late-breaking studies, we're consistently building our body of new, short-, and long-term research around innovative, minimally-invasive TPV solutions for CHD patients," added Sandra Lesenfants, vice president and general manager of the Structural Heart division, which is part of the Cardiac and Vascular Group at Medtronic.

13:24 EDT Atlantic Power CEO buys 25,000 shares - Atlantic Power CEO James Moore disclosed in a regulatory filing his purchase of 25,000 shares of company common stock on May 15 at an average price of $1.86 per share for a total transaction value of $46,500.

13:17 EDT Tiger Global bought 4.15M shares of Peloton during Q1 for $110.3M

13:11 EDT Moncef Slaoui confident COVID-19 vaccine coming by end of 2020 - Moncef Slaoui, who oversees the White House's "Operation Warp Speed" to advance COVID-19 vaccines, said during a Rose Garden press conference, "I have very recently seen early data from a clinical trial with a coronavirus vaccine and these data made me feel even more confident that we will be able to deliver a few hundred million doses of vaccine by the end of 2020." Slaoui just resigned from the board of Moderna (MRNA) upon assuming the new role.

13:04 EDT Baker Hughes reports U.S. rig count down 35 to 339 rigs - Baker Hughes reports that the U.S. rig count is down 35 rigs from last week to 339, with oil rigs down 34 to 258, gas rigs down 1 to 79, and miscellaneous rigs unchanged at 2. The U.S. Rig Count is down 648 rigs from last year's count of 987, with oil rigs down 544, gas rigs down 106, and miscellaneous rigs up 2 to 2. The U.S. Offshore Rig Count is down 3 rigs from last week to 12 and down 10 year-over-year. The Canada Rig Count is down 3 rigs from last week to 23, with oil rigs unchanged at 7 and gas rigs down 3 to 16. The Canada Rig Count is down 40 rigs from last year's count of 63, with oil rigs down 15 and gas rigs down 25.

12:37 EDT Beckman Coulter awarded expanded partnership with BARDA - Beckman Coulter, a unit of Danaher, announced it was awarded an expanded partnership with BARDA as part of their rapidly expanding COVID-19 medical countermeasure portfolio. The partnership was awarded to Beckman Coulter, in collaboration with Dascena, Inc., for additional advanced research and development toward optimization of a machine-learning based sepsis diagnostic and prediction algorithm to include assessing its use with coronavirus patients. The sepsis diagnostic and prediction algorithm builds on Beckman Coulter's existing Early Sepsis Indicator, which received FDA 510(k) clearance in April 2019, combining the monocyte distribution width novel laboratory test parameter values with Dascena's electronic health record data based machine-learning algorithm to help accurately predict and detect those with sepsis This COVID-19 specific study is part of BARDA's Rapidly Deployable Capabilities program to identify and pilot near-term innovative solutions for COVID-19, leveraging the development of Beckman Coulter's digital sepsis prediction algorithm under BARDA's Division of Research Innovation and Venture's Solving Sepsis Program.

12:28 EDT American Express reports April net write-off rate 2.7% vs. 2.8% last month - Reports April 30 days past due U.S. Consumer Card Member loans 1.7% vs. 1.7% last month.

12:21 EDT CorEnergy says bankruptcy filing of UPL constitute defaults under lease terms - CorEnergy Infrastructure Trust announced that, on May 14, 2020, UPL filed a voluntary petition to reorganize under Chapter 11 of the United States Bankruptcy Code. The filing includes Ultra Wyoming, the operator of the Pinedale LGS and tenant under the Pinedale Lease Agreement with the company's indirect wholly owned subsidiary Pinedale LP. "The bankruptcy filing of both the guarantor, UPL, and the tenant constitute defaults under the terms of the Pinedale Lease. The bankruptcy filing imposes a stay of CorEnergy's ability to exercise remedies for the foregoing defaults. Ultra Wyoming has also filed a motion to reject the Pinedale Lease, with a request that such motion be effective June 30, 2020. The company expects to engage in negotiations with UPL, although the outcome of any negotiations is uncertain at this time...As previously disclosed, the company's Board of Directors has declared a first quarter 2020 dividend of $0.05 per share for the company's common stock and a dividend of $0.4609375 per depositary share for the Company's 7.375% Series A Cumulative Redeemable Preferred Stock, with each such dividend payable on May 29, 2020, to shareholders of record on May 15, 2020. The Board of Directors will continue to evaluate the company's dividend payments on a quarterly basis, including the impact of any potential future reduction or loss of rent under the Pinedale Lease," the company stated.

12:00 EDT Viad falls -10.0% - Viad is down -10.0%, or -$1.66 to $14.98.

12:00 EDT NeoPhotonics falls -15.2% - NeoPhotonics is down -15.2%, or -$1.32 to $7.39.

12:00 EDT Regional Management rises 20.8% - Regional Management is up 20.8%, or $2.50 to $14.52.

11:25 EDT Oppenheimer Holdings authorizes repurchase of up to 530,000 class A shares - Oppenheimer Holdings announced that its Board of Directors approved a share repurchase program that authorizes the company to purchase up to 530,000 shares of the company's Class A non-voting common stock, representing approximately 4.2% of its 12,636,523 currently issued and outstanding shares of Class A non-voting common stock. This authorization will supplement the 98,625 shares that remain authorized and available under the company's previous share repurchase program covering up to 640,000 shares of the company's Class A non-voting common stock, which was announced on July 26, 2019, for a total of 628,625 shares authorized and available for repurchase. The share repurchase program is expected to continue indefinitely.

11:10 EDT Toyota plans to cut Japan production in June, will halt production for four days - Toyota said in a statement that "Due to the effects of COVID-19 on the current market and the decline in demand of new vehicles globally, Toyota intends to continually make gradual adjustments in production operations at all plants for completed vehicles in Japan. We sincerely apologize for the inconvenience caused to our suppliers and people in those regions. Specifically, we have decided to halt production at all plants for completed vehicles in Japan for four days, on June 5, 12, 19 and 26. In addition to the above non-operating days, we plan to halt production as well as reducing operation time from double shifts to a single shift for some of the plants and production lines."

11:03 EDT Sorrento says antibody shows 100% inhibition of COVID virus in 'in vitro' test - Sorrento Therapeutics announced that its anti-SARS-CoV-2 antibody, STI-1499, demonstrated 100% inhibition of SARS-CoV-2 virus infection in an in vitro virus infection experiment at a very low antibody concentration. As recently announced, Sorrento aims to generate an antibody cocktail product that would act as a "protective shield" against SARS-CoV-2 coronavirus infection and remain effective even if virus mutations render a single antibody therapy less effective over time. Sorrento has determined STI-1499 will likely be the first antibody in the antibody cocktail "COVI-SHIELD" it is developing, as recently announced. STI-1499 is also expected to be developed as a stand-alone therapy, "COVI-GUARD," because of the high potency it has exhibited in experiments to date. Sorrento plans to request priority evaluation and accelerated review from regulators to determine the best pathway to make any potential treatment available as soon as possible. "Sorrento's existing state-of-the-art cGMP antibody manufacturing facility in San Diego is expected to be able to produce up to two hundred thousand doses per month and the company intends to produce a million doses at risk while seeking FDA approval for any STI-1499 product candidate. The company is seeking potential government support and pharmaceutical partners to further scale up STI-1499 manufacturing capacity with a goal of potentially providing tens of millions of doses in a short period of time to meet the vast projected demand," Sorrento said. "Our STI-1499 antibody shows exceptional therapeutic potential and could potentially save lives following receipt of necessary regulatory approvals. We at Sorrento are working day and night to complete the steps necessary to get this product candidate approved and available to the waiting public," stated Dr. Henry Ji, Chairman and CEO of Sorrento.

10:34 EDT Facebook announces acquisition of visual expression company GIPHY - Facebook announced that visual expression company GIPHY is joining its Instagram team. Axios reported Facebook paid $400M to acquire the company. "GIPHY makes everyday conversations more entertaining, and so we plan to further integrate their GIF library into Instagram and our other apps so that people can find just the right way to express themselves," Facebook said in a statement. It added, "We've used GIPHY's API for years, not just in Instagram, but in the Facebook app, Messenger and WhatsApp. GIPHY will continue to operate its library (including its global content collection), and we're looking forward to investing further in its technology and relationships with content and API partners." Reference Link

10:28 EDT J.C. Penney trading resumes, shares jump 27% to 26c

10:24 EDT Datametrex announces C$500 purchase order for COVID-19 test kits - Datametrex AI Limited announced it has received a purchase order for COVID-19 test kits from a Canadian based mining company "with over 4,000 employees in multiple jurisdictions outside of Canada." Under the terms of the order, Datametrex will sell to the purchaser an initial 10,000 units of COVID-19 Detection Kits, comprising of 10,000 3 mL Universal Transport Medium Sterile Swabs with 16x100mm Skirted Tubes with Plastic Red Capture Caps, and 1 Real-Time PCR Detection System machine to analyze the samples. The total gross sales amount is approximately C$500,000, excluding shipping. Datametrex anticipates that it will have little or no upfront costs associated with the sale of these test kits. The company has secured all testing kits, swabs, tubes and the PCR machine from the manufacturer required to fulfill the order. All of the items will be shipped directly from manufacturers to the purchaser at their operating site in Africa.

10:13 EDT Sorrento Therapeutics extends rally, shares up 90% to $4.97

10:02 EDT Extended Stay America addresses impact of COVID-19 with STAY Confident - Extended Stay America announces the debut of a new initiative, STAY Confident, to focus on the health, safety, and comfort of its guests. STAY Confident will build upon Extended Stay America's experience as the only major hotel brand to remain 100% open since the beginning of the pandemic and the already high standards of housekeeping and hygiene at its 634 locations. STAY Confident includes three focus areas: STAY Safe, STAY Healthy, and STAY Comfortable, with the goal of ensuring the overall wellbeing of its guests. In addition to providing guests with peace of mind regarding health and cleanliness, Extended Stay America is also offering more discounts - particularly on longer-term stays - to help alleviate the financial stress created by this pandemic. For example, Extended Stay America is offering up to 60 percent off stays of 60 days or more.

10:00 EDT Canada Goose falls -8.8% - Canada Goose is down -8.8%, or -$1.82 to $18.88.

10:00 EDT NeoPhotonics falls -15.7% - NeoPhotonics is down -15.7%, or -$1.36 to $7.34.

10:00 EDT Regional Management rises 15.3% - Regional Management is up 15.3%, or $1.83 to $13.86.

09:47 EDT Direxion Daily Junior Gold Miners Index Bear 3x Shares falls -7.0% - Direxion Daily Junior Gold Miners Index Bear 3x Shares is down -7.0%, or -$1.70 to $22.59.

09:47 EDT Farfetch falls -10.1% - Farfetch is down -10.1%, or -$1.61 to $14.28.

09:47 EDT New Relic rises 13.9% - New Relic is up 13.9%, or $8.10 to $66.38.

09:45 EDT Morningstar Credit Ratings settles asset-backed securities SEC probe for $3.5M - Morningstar announced that Morningstar Credit Ratings has entered into a settlement with the Securities and Exchange Commission to resolve an investigation into whether certain activities of MCR's asset-backed securities staff in 2015 to 2016 complied with sales and marketing rules applicable to Nationally Recognized Statistical Rating Organizations. MCR, which will pay $3.5M as part of the settlement, did not admit or deny the SEC's charges. "MCR cooperated with the SEC's multi-year investigation and believes the settlement is in the best interest of the company. There are no allegations that any credit ratings issued by MCR were affected by the conduct described in the settlement," Morningstar said in a statement. It added, "MCR takes its regulatory obligations seriously, and the integrity of its credit ratings is of paramount importance. As part of its integration with DBRS, which Morningstar acquired last year and well after the investigated activity took place, the combined DBRS Morningstar has enhanced and will further strengthen policies, procedures, and internal controls. It will also conduct additional training to reinforce compliance with regulations."

09:40 EDT Majesco trading resumes

09:35 EDT Majesco trading halted, volatility trading pause

09:26 EDT Sundial Growers: Q1 branded net cannabis sales 54% of total net cannabis sales - Branded net cannabis sales increased to 54% of total net cannabis sales in the first quarter of 2020 vs. 33% in the fourth quarter of 2019. Reports inventory write-down of $14.4M, on dried cannabis and cannabis extracts, primarily driven by product price compression due to broader trends of oversupply in the Canadian market. Since January 2020, the company has reduced its workforce by 51% to optimize its cost structure to align with market conditions. Sundial currently has 420 employees.

09:20 EDT Sundial Growers says no 'material impact to sales' in Q1 from COVID-19 - The company is monitoring daily developments in the COVID-19 pandemic and actions taken by the government authorities. In accordance with the guidance of provincial and federal health officials to limit the risk and transmission of COVID-19, Sundial has implemented mandatory self-quarantine policies, travel restrictions, enhanced cleaning and sanitation processes and frequency, and social distancing measures. Sundial believes that it can maintain safe operations with these pandemic-related procedures and protocols in place. Sundial did not experience a material impact to sales in the first quarter from COVID-19.

09:16 EDT SORL Auto Parts completes merger with Ruili International Merger Sub - SORL Auto Parts announced the completion of the merger of the Company with Ruili International Merger Sub, a wholly owned subsidiary of Ruili International, a Delaware corporation, pursuant to the previously announced Agreement and Plan of Merger dated as of November 29, 2019, by and among the Company, Parent and Merger Sub. Under the terms of the Merger Agreement, which was approved by the Company's stockholders at its special meeting of stockholders held on May 8, 2020, each share of Company common stock issued and outstanding prior to the effective time, other than shares held by Parent which shares have been cancelled for no consideration, has been converted into the right to receive $4.72 per share in cash, without interest and net of any applicable withholding taxes. As a result of the Merger, SORL became a wholly owned subsidiary of Parent, and the shares of the Company common stock no longer trade on the NASDAQ Global Market. Stockholders of record as of the effective time of the Merger who are entitled to the merger consideration will receive a letter of transmittal and instructions on how to surrender their share certificates in exchange for the merger consideration. Stockholders should wait to receive the letter of transmittal before surrendering their share certificates. In connection with the consummation of the Merger, the Company has requested that trading of its common stock on NASDAQ be suspended prior to opening of trading on May 15, 2020. The Company requested that NASDAQ file with the SEC a Form 25 relating to the delisting of the Company's common stock from NASDAQ and the deregistration of the Company's registered securities. The Company intends to file a Form 15 with the SEC under the Securities Exchange Act of 1934, as amended, requesting the deregistration of the Company's shares of common stock, under Section 12(g) of the Exchange Act and the suspension of the Company's reporting obligations under Section 15(d) of the Exchange Act. The Company's obligations to file with the SEC certain reports and forms, including Form 10-K, Form 10-Q and Form 8-K, will be suspended immediately as of the filing date of the Form 15 and will cease once the deregistration becomes effective.

09:13 EDT UroGen Pharma presents OLYMPUS trial data at AUA virtual meeting - UroGen Pharma announced the presentation of data from the UGN-101 Phase 3 OLYMPUS trial in patients with low-grade upper tract urothelial cancer, or LG-UTUC. The study was accepted for the 2020 American Urological Association, or AUA, annual meeting, published as a supplement to the April issue of The Journal of Urology and presented as part of the AUA Virtual Experience. Seventy-four patients with biopsy-proven, LG UTUC were enrolled to receive six weekly instillations via retrograde catheter of UGN-101 to the renal pelvis and calyces. All patients had measurable tumor 5-15mm diameter. Four to six weeks following the last instillation, eligible patients underwent a primary disease evaluation, or PDE, including ureteroscopy and wash cytology, and biopsy of any suspicious lesions. A complete response, or CR, was defined as negative ureteroscopic evaluation and negative cytology. Patients achieving CR were to continue to monthly maintenance and quarterly follow up for durability. Of 74 patients enrolled, 71 received at least one dose of UGN-101. A total of 59% achieved a CR. Thirty-four patients were characterized by the treating physician as having endoscopically unresectable tumor at baseline and 59% of these individuals also achieved a CR. Durability of CR was estimated at 89% at six months and 84% at 12 months by Kaplan-Meier analysis. Median time to recurrence was 13 months. Overall, seven of 41 patients who achieved a CR have had a documented recurrence. No treatment-related deaths occurred to date. The most common reported adverse events were ureteral stricture, urinary tract infection, hematuria, flank pain and nausea. Data from the OLYMPUS Trial demonstrate that non-surgical chemoablation of LG UTUC with intracavitary UGN-101 results in a high rate of initial disease eradication that is durable in the majority of patients.

09:06 EDT VF Corp. expects ongoing retail disruption throughout FY21 - Says that the company expects North America and EMEA to begin to reopen in Q1. Says expects North America and EMEA will continue to steadily improve with APAC stabilizing in Q2. Says expects North America and EMEA to stabilize and APAC to begin to return to growth in Q3. Says in Q4 North America and EMEA will begin to return to growth with APAC returning to more normalized growth. Says shift toward digital will accelerate in FY21. Says net proceeds from Occupational Work divestiture is incremental to liquidity estimates. Says has strong commitment to dividend. Sees $600M of free cash flow in FY21. Comments taken from investor presentation slides and Q4 earnings conference call.

09:04 EDT Monitronics appoints Kevin Lyons as chief people officer - Monitronics International (SCTY) announced the addition of two new executives to their senior leadership team. Kevin Lyons will join as Chief People Officer, effective May 18, 2020 and Wade Gibson will join as SVP of Network Sales, effective May 25, 2020. Most recently, Mr. Lyons served as a Senior Director at Keurig Dr Pepper (KDP). Mr. Gibson most recently practiced law at Locke Lord LLP, where he advised both public and privately held companies on major corporate transactions and governance matters.

09:03 EDT MySize provides Q1 business update - My Size provided a business update for the first quarter ended March 31. Highlights include: Regained compliance with Nasdaq's stockholders' equity rule; Raised approximately $5M in gross proceeds in public offering; Increased demand for MySizeID due to COVID-19 pandemic; Developed contactless solution for MySizeID app, allows customers to purchase clothing through the app; Released OneClick feature for BoxSize- allows the user to easily and quickly measure a package in a single motion; Signed non-binding LOI to establish a Joint Venture with Logystico to operate and manage micro-fulfilment centers using My Size's BoxSize enhanced platform for retail vendors in the United States.

08:59 EDT Morningstar to pay $3.5M to settle SEC probe over ratings - The Securities and Exchange Commission charged New York-based credit rating agency Morningstar Credit Ratings LLC for violating a conflict of interest rule designed to separate credit ratings and analysis from sales and marketing efforts. Morningstar has agreed to pay $3.5M to settle the charges. The SEC's order finds that from mid-2015 through September 2016, credit rating analysts in Morningstar's asset-backed securities group engaged in sales and marketing to prospective clients. "Credit rating agencies must be vigilant to prevent potential conflicts of interest between their ratings functions and their sales and marketing activities," said Daniel Michael, Chief of the SEC Enforcement Division's Complex Financial Instruments Unit. "As the SEC's order finds, Morningstar sometimes enlisted its analysts in business development efforts, introducing the exact conflict of interest that the rule is intended to eliminate." Reference Link

08:45 EDT Cassava Sciences trading resumes

08:40 EDT FOREWARN parnters with Northwestern Wisconsin Multiple Listing Service - FOREWARN announced that the Northwestern Wisconsin Multiple Listing Service has contracted to make FOREWARN services available for the 1,100+ REALTOR(R) members it serves in an effort to promote proactive real estate agent safety. Available both online and through a mobile application, FOREWARN analyzes billions of data points and provides users with the ability to mitigate risks by verifying identity, searching for criminal histories, and validating information provided by potential clients such as financial and asset information -- using just a phone number. FOREWARN allows agents to properly and safely plan for showings with a higher level of confidence. The FOREWARN services purchased by NWWMLS will be available to NWWMLS's entire 1,100+ real estate agent membership at no additional cost to individual agents.

08:39 EDT Beyond Air enters into common stock purchase agreement with Lincoln Park Capital - Beyond Air announced that it has entered into a new common stock purchase agreement and registration rights agreement with Lincoln Park Capital Fund, LLC , a Chicago-based fundamentally focused, long-term institutional investor, for up to $40 million. The new Agreements extend until May 2023 and replace existing agreements between the Company and LPC, which were set to expire in August of 2021. Under the Agreements and upon instruction from Beyond Air, LPC will purchase 325,000 shares of registered common stock at $8.58 per share, which represents a 10% premium to the average closing share price for the most recent five days. According to the terms of the purchase agreement, Beyond Air will have the right at its sole discretion to sell to LPC the balance of up to $40 million worth of shares over a 36-month period. Beyond Air will control the timing of any future investment and LPC will be obligated to make purchases in accordance with the purchase agreement. There are no upper limits to the price per share LPC may pay to purchase the remaining common stock subject to the purchase agreement. No warrants, derivatives, financial or business covenants are associated with the purchase agreement and LPC has agreed not to cause or engage in any manner whatsoever, in any direct or indirect short selling or hedging of shares of the Company's common stock. In consideration for entering into the purchase agreement and committing to fund up to $40 million, Beyond Air has paid LPC a 2.5% cash commitment fee. The purchase agreement may be terminated by the Company at any time, at its sole discretion, without any cost or penalty.

08:38 EDT BIO-key CEO says outlook is 'strong' for 2020 - CEO Michael DePasquale continued, "Reflecting actions taken in 2019, our Q1'20 bottom-line performance improved substantially compared to the same period in 2019, and we have a strong outlook for 2020. We expect to commence work on our large African contracts in the coming months and expect to receive upfront deposits to precede our efforts. Given their scale and expected duration, these projects alone position BIO-key for substantial revenue growth and for the full year 2020, and we are confident they will allow us to pursue other large-scale opportunities in Africa and on a global basis. We look to provide more visibility into the timing and expected impact of our Africa business as final planning is completed and the projects are underway."

08:32 EDT BioCardia announces anticipated upcoming milestones - Q2 2020: Phase III pivotal trial commencement and first sites activated in CardiAMP Chronic Myocardial Ischemia Trial. Q2 2020: FDA acceptance of Investigational New Drug application for CardiALLO Neurokinin-1 Receptor Positive Mesenchymal Stem Cell Therapy, the Company's second therapeutic platform, for the treatment of ischemic heart failure. Q4 2020: Pre-specified Data Safety Monitoring Board Review of all patients enrolled, including futility analysis, based on sixty patients that will have reached the primary one-year follow-up endpoint at the time of analysis. Q4 2020: Pre-specified Data Safety Monitoring Board Review of safety data from roll-in cohort in CardiAMP CMI Trial. Q4 2020: FDA acceptance of Investigational New Drug application for Neurokinin-1 Receptor Positive Mesenchymal Stem Cell Therapy for the treatment of Acute Respiratory Distress Syndrome as a result of COVID-19.

08:26 EDT Outlook Therapeutics expects topline results from NORSE 1 study in 3Q20 - The company said, "The Company recently announced it received U.S. Food and Drug Administration (FDA) tentative approval of the trade name for ONS-5010 as LYTENAVA. The trade name is conditionally approved by FDA and will be subject to further review at the time of the Company's planned filing of a new biologics license application with the FDA under the 351 PHSA regulatory pathway for LYTENAVA in 2021. The NORSE 1 registration clinical trial completed enrollment in August 2019 and is on pace to report topline data in August 2020. NORSE 1 enrolled a total of 61 patients at nine sites in Australia. NORSE 1 will provide initial safety and efficacy data for ONS-5010 in wet AMD patients for ONS-5010 dosed monthly compared to LUCENTIS dosed using the PIER alternative dosing regimen of three monthly doses followed by quarterly dosing. The Company anticipates reporting data during the third calendar quarter of 2020. At this time, the COVID-19 pandemic is not expected to affect the completion of NORSE 1 and anticipated data readout date. The NORSE 2 registration clinical trial commenced patient enrollment in July 2019 and is expected to enroll a total of approximately 220 patients at more than 40 clinical trial sites in the United States. NORSE 2 continues to screen, enroll and treat patients, subject to additional COVID-19 safety protocols for both patients and staff at trial sites. Patients in the trial will be treated for 11 months. The primary outcome of the study is a statistically significant difference in the proportion of patients who gain at least 15 letters in the best corrected visual acuity for ONS-5010 over LUCENTIS. Outlook Therapeutics estimates that, subject to local conditions which have varying degrees of "shelter-in-place" and other similar government orders mandating various restrictions due to COVID-19, enrollment will be completed no later than August of 2020. The Company intends to complete development of ONS-5010 for submission to the FDA as a new BLA under the 351(a) PHSA regulatory pathway for the treatment of wet AMD. The Company also has plans to submit for regulatory approvals in France, United Kingdom, Italy, Germany, Spain and Japan, as well as other countries. If approved, ONS-5010 will be the first and only on-label ophthalmic formulation of bevacizumab for treating retinal diseases."

08:20 EDT Cassava Sciences says Phase 2b study of PTI-125 does not meet primary endpoint - Cassava Sciences reported top-line results from a Phase 2b study of PTI-125, its lead investigational drug, in patients with Alzheimer's disease. This study did not meet its primary endpoint. The pre-specified primary endpoint was a statistically significant effect of PTI-125 versus placebo on cerebrospinal fluid levels of tau protein and other biomarker assessments from baseline to Day 28. PTI-125 significantly reduced a secondary endpoint, CSF levels of IL1-beta, a core biomarker of neuroinflammation, from baseline to Day 28. Drug was safe and well-tolerated. A post-hoc analysis of biomarker data revealed high variability in levels of CSF biomarkers over 28 days. For example, placebo-treated patients recorded changes in levels of CSF tau and p-tau ranging from -54% to +34% and -49% to +253%, respectively, from baseline to Day 28. Biomarker analysis was conducted by outside labs. The drug effects of PTI-125, if any, may have been masked in this study by high variability in levels of biomarkers of disease. In the months ahead the Company plans to re-analyze CSF biomarkers from all study participants. Phase 2b was a double-blind, randomized, placebo-controlled study of PTI-125 in 64 patients with mild-to-moderate Alzheimer's disease, 50-85 years of age, with MMSE 16 to 26. Participants received PTI-125 100 mg, 50 mg or matching placebo, twice-daily, for 28 continuous days.

08:18 EDT Guardant Health presents data on liquid biopsy for precision oncology - Guardant Health along with leading academic institutions and pharmaceutical companies will present data highlighting the use of the company's proprietary blood tests to advance precision oncology across the continuum of care at the upcoming 2020 American Society of Clinical Oncology Annual Meeting, being held from May 29-31; and the AACR Virtual Annual Meeting II, scheduled for June 22-24. More than 25 abstracts, now online, demonstrate how blood-based comprehensive genotyping is integral to the adoption of precision oncology in advanced cancer. The data highlights the use of Guardant360 and GuardantOMNI liquid biopsy tests to detect clinically actionable mutations and to help inform treatment for patients as their cancer progresses. Key findings demonstrate high concordance with tissue biopsies, the advantages over tissue biopsies to detect clinically relevant mutations for rule-in and rule-out decisions, and feasibility of serial testing from patient plasma to reveal tumor evolution and resistance in response to intervening therapies, including immunotherapies. Additionally, researchers will present data indicating the effectiveness of new targeted therapies. LUNAR-2 Liquid Biopsy Demonstrates Improved Performance in Detecting Early-Stage Colorectal Cancer: AACR data shows improved performance of the LUNAR-2 liquid biopsy to detect early-stage colorectal cancer in average-risk adults. In a blinded cohort analysis of colonoscopy screened negative patients and patients newly diagnosed with early stage CRC using a further optimized, integrated genomic and epigenomic analysis, the LUNAR-2 assay demonstrated overall sensitivity of 90.3% and overall specificity of 96.6%, representing a slight improvement over previously reported data. Guardant360 Clinical-Genomic Dataset Highlights Value of Liquid Biopsy for Precision Oncology Drug Development: AACR data quantifies the value of Guardant Health's clinical-genomic real-world evidence dataset, GuardantINFORM, to enable drug development using circulating tumor DNA as an alternative to serial tissue testing. In a cohort of patients who underwent Guardant360 serial ctDNA testing and linked to de-identified medical and pharmacy claims, a robust longitudinal view of the patients' diagnosis, treatments, and clinical outcomes was accessible for a majority of patients. The availability of clinical-genomic information following systemic therapy confirms that this dataset could serve as a viable resource for precision oncology drug development researchers to evaluate drug resistance and tumor evolution in a real-world setting. ASCO data highlights the status of two prospective, multi-center clinical trials validating the clinical utility of the LUNAR-1 liquid biopsy to guide adjuvant treatment decisions for colon cancer.

08:15 EDT Pfizer announces updated PF-06939926 preliminary data - Pfizer announced updated Phase 1b clinical data on PF-06939926, an investigational gene therapy being developed to treat Duchenne muscular dystrophy, or DMD. The preliminary data from nine ambulatory boys with DMD, aged six to 12 indicate that the intravenous administration of PF-06939926 was well-tolerated during the infusion period, with encouraging efficacy and manageable safety events, even when considering those adverse events that were more severe in nature. The treatment provided durable and statistically significant improvements across multiple efficacy-related endpoints measured at 12 months post-infusion, including sustained levels of mini-dystrophin expression and improvements on the North Star Ambulatory Assessment, or NSAA, rating scale, which is a validated measure of muscle function. Three serious adverse events, or SAEs, were recorded, two of which reflected likely complement activation. While these two SAEs were severe in nature, all three events fully resolved within two weeks, providing encouragement that close monitoring and early intervention can help mitigate the effects of complement activation. This new dataset, which includes updated 12-month results on safety, dystrophin expression, and exploratory functional endpoints for 3 additional boys, was presented for the first time during a virtual oral session today at the American Society of Gene & Cell Therapy annual meeting. DMD is a devastating and life-threatening X-linked disease that is caused by mutations in the gene encoding dystrophin, which is needed for proper muscle membrane stability and function. Patients present with muscle degeneration that progressively worsens with age to the extent that they require wheelchair assistance when they are in their early teens, and unfortunately, usually succumb to their disease by the time they are in their late twenties. Data presented at the ASGCT virtual meeting included results from the study of nine ambulatory boys with DMD. Three of those nine patients received a one-time intravenous infusion of PF-06939926 at 1E14 vector genomes per kilogram, or vg/kg, and the other six received a one-time intravenous dose of 3E14 vg/kg. The primary endpoint of the Phase 1b study is to assess the safety and tolerability of this investigational gene therapy in ambulatory boys with Duchenne muscular dystrophy through 12 months following treatment. Based on the data to date, the most common adverse events, or AEs, suspected to be related to PF-06939926 were vomiting, nausea, decreased appetite, and pyrexia. There was no evidence of clinically relevant anti-dystrophin responses or hepatic dysfunction with the protocol-defined daily glucocorticoid regimen. Among the 9 patients, 3 serious adverse events, or SAEs, were reported in the first 14 days following administration, one more SAE than at Pfizer's previous update. Importantly, each of these SAEs was fully resolved and at their last clinic visits, all patients were doing well. The first SAE involved persistent vomiting resulting in dehydration, which required admission for IV anti-emetics and fluids. The second SAE involved acute kidney injury with atypical hemolytic uremic syndrome-like complement activation, which required hemodialysis and treatment with eculizumab. The most recent SAE involved thrombocytopenia with aHUS-like complement activation which required platelet transfusion and treatment with eculizumab. Based on safety observations over the course of the study, Pfizer amended the clinical study protocol to include increased monitoring and management regimes, which helped enable timely intervention and mitigation in the case of the third SAE. Secondary endpoints of the clinical study included measurement of mini-dystrophin concentration by liquid chromatography mass spectrometry and distribution within muscle fibers by immunofluorescence. Dystrophin concentrations in healthy or "normal" muscle, or muscle with no known disease, vary widely between samples and individuals, and no industry standard currently exists for defining a "normal" level. Historically, dystrophin concentration was measured by Western Blot. However, due to limitations of this methodology, Pfizer leveraged its internal expertise in immuno-affinity mass spectrometry protein quantification and developed a proprietary assay to measure dystrophin concentration with a wide dynamic range and low variability. This novel LCMS assay is an anti-peptide antibody enriched, immunoaffinity liquid chromatography tandem mass spectrometry assay that has been validated by Pfizer in preclinical species and human tissues and discussed with the FDA. Using this LCMS assay, "normal" concentrations of dystrophin were established to compare to secondary endpoint results in patients. These "normal" reference levels were based on pooled skeletal muscle biopsies from 60 pediatric samples. In the Phase 1b trial, new results from open muscle biopsies of the biceps of the three patients in the low dose cohort showed that the mean percent normal dystrophin at 12 months was 24.0%. For the 3 patients in the high-dose cohort for whom 12-month data are available, the mean percent normal dystrophin at 12 months was 51.6%. Comparisons between baseline and post-treatment measures were significant. The increases in dystrophin levels observed at two months were generally sustained at 12 months, and five of the six boys showed an increase in mini-dystrophin concentration between the two and 12-month time points. New results from open muscle biopsies of the biceps at both dose levels using an updated digital platform and analysis with a new quantitative imaging algorithm show dystrophin immunofluorescence, measured as the proportion of muscle fibers expressing dystrophin. Of the three patients in the low dose cohort, the mean percent positive fibers was 28.5% at two months and 21.2% at 12 months. Of the six patients in the high dose cohort, the mean percent positive fibers at two months was 48.4%. For the three patients in the high dose cohort for whom 12-month data are available, the mean percent positive fibers was 50.6% at 12 months. The patients in Pfizer's Phase 1b study, showed a significant functional improvement from baseline NSAA scores after one year, compared with the scores in an independent, external control group derived from recent prior clinical trials involving boys with DMD, who were matched specifically by age, weight and function. A second exploratory analysis using MRI showed a reduction in fat fraction in the thighs of boys treated with the high dose at 12 months post-treatment. Boys with DMD typically exhibit a progressive loss of contractile or lean muscle and replacement with fat and fibrotic tissue. In this study, a reduction in fat fraction was observed in boys from the high dose-treated cohort when compared to an external placebo group, suggesting that gene therapy may have improved muscle fiber health and quality in these boys. No reduction in fat fraction was seen in the low dose group.

08:13 EDT Rapt Therapeutics highlights eary results for RTI193 at SID meeting - RAPT Therapeutics announced that researchers presented encouraging results from preclinical and healthy volunteer studies for RPT193 at the Society for Investigative Dermatology Meeting. RPT193 is a small molecule, once-daily oral therapy in development for the treatment of atopic dermatitis and other allergic inflammatory diseases. During the session, Laurence Cheng, M.D., Ph.D., Senior Medical Director at RAPT Therapeutics, presented blinded Phase 1a data from healthy volunteer cohorts of an ongoing seamless Phase 1 study showing that once-daily oral dosing of RPT193 for seven days achieved target drug levels and target coverage with an excellent safety profile in healthy volunteers. In addition, Dr. Cheng noted that in multiple preclinical studies of allergic skin inflammation, once-daily dosing of RPT193 demonstrated efficacy and reduction of Th2 cytokines comparable to treatment with currently available biologics that work by blocking interleukin-4 and IL-13, the major drivers of allergic inflammatory disease.

08:12 EDT Ultragenyx announces data from confirmatory cohort of Phase 1/2 study of DTX401 - Ultragenyx Pharmaceutical announced positive initial data from the confirmatory third cohort and longer-term data from the first two cohorts of the ongoing Phase 1/2 study of DTX401, an adeno-associated virus based gene therapy for the treatment of glycogen storage disease type Ia. All three patients in Cohort 3 responded to therapy and demonstrated more rapid reductions in cornstarch requirements compared to the first two cohorts. Across all cohorts, 100 percent of patients demonstrated meaningful and sustained cornstarch reductions over time and significant increases in time to hypoglycemia. Data from the Phase 1/2 study are being presented today at the American Society of Gene & Cell Therapy virtual meeting. Based on results and lessons learned from Cohorts 1 and 2, three modifications were made to the protocol for the confirmatory Cohort 3. First, the cornstarch dose at the start of each controlled fasting challenge was reduced from 35 grams to 5 grams to reduce an acute rise in glucose followed by an insulin surge, resulting in early termination of the fasting challenge. Second, continuous glucose monitoring was implemented to allow more accurate cornstarch management. Third, the reactive use of steroids was optimized to begin steroids earlier, when alanine aminotransferase levels increase from baseline, even if still within the normal range. Early Transgene Expression Demonstrated in Confirmatory Cohort 3: In Cohort 3, CGM data showed early transgene expression within days of dosing with DTX401. This was demonstrated by prolonged periods of hyperglycemia, which is consistent with glucose being released from the liver and transgene expression. Rapid Cornstarch Reduction in Cohort 3 and Further Reduction in Earlier Cohorts: In the confirmatory cohort, CGM enabled more rapid reduction of cornstarch intake following observations of hyperglycemia at home, which minimized the insulin response and provided more metabolic stability for patients. At Week 12, patients in Cohort 3 had reduced mean daily cornstarch intake by 57 percent, compared with 38 percent in the first cohort and 14 percent in the second cohort. Patients in Cohort 1 and 2 continue to decrease cornstarch with a mean 73 percent reduction as of the data cutoff of April 23, 2020, demonstrating durable responses over time. Four of the six patients in the first two cohorts have now discontinued daytime cornstarch, and one patient has completely discontinued cornstarch. Optimized Reactive Steroids More Effectively Mitigated Elevations in Liver Transaminases: Patients in Cohort 3 received an optimized reactive steroid regimen as soon as alanine aminotransferase levels began to rise above baseline, at approximately Week 4 for all three patients in the cohort. This earlier steroid use was more effective at mitigating elevations in ALT, and could further enhance the level and consistency of expression that has been demonstrated. Early Improvements in Time to Hypoglycemia Observed for All Patients: By decreasing the cornstarch at the beginning of the controlled fasting challenge, the mean baseline time to hypoglycemia decreased from 4.5 hours in Cohorts 1 and 2, to 2.3 hours in Cohort 3, with two patients in Cohort 3 under 2 hours. At week 12, all patients in Cohort 3 demonstrated meaningful increases in time to hypoglycemia. Patient 7 demonstrated a 167 percent increase. Patient 8 demonstrated a 23 percent increase. Patient 9 demonstrated a 60 percent increase. Due to the COVID-19 pandemic, only Week 12 controlled fasting challenges have been conducted to date for Cohort 3, as patients were not able to complete the Week 24 in-hospital fasting challenges. It will be important to monitor these patients as they adapt to their lower cornstarch regimen to continue to assess their glucose metabolism. As of the cutoff date, there have been no infusion-related adverse events and no treatment-related serious adverse events reported. All adverse events have been Grade 1 or 2. Seven of the nine patients in the study had mild, asymptomatic ALT elevations, including all three patients in Cohort 3. These elevations were similar to what has been observed in other programs using AAV-based gene therapy, and were successfully treated with reactive steroids. The optimized reactive steroid regimen used in Cohort 3 was more effective at rapidly mitigating elevations in ALT compared with earlier cohorts. Ultragenyx is continuing to collect longer-term data from the Phase 1/2 study, which is expected to be available in the second half of 2020, barring further significant delays related to COVID-19. The company also intends to hold an end-of-Phase 2 meeting with the U.S. Food and Drug Administration in the second half of 2020. The Phase 3 study could begin by the end of this year, depending on whether there are any COVID-19 related delays.

08:09 EDT Integra LifeSciences announces clinical results for Integra Bilayer Wound Matrix - Integra LifeSciences Holding Corporation announced clinical and economic data on Integra Bilayer Wound Matrix (IBWM) in complex lower extremity reconstruction. This data from two retrospective studies was recently published by Stephen J. Kovach, M.D., FACS, and John P. Fischer, M.D., MPH, FACS, from the University of Pennsylvania Health System, in Plastic and Reconstructive Surgery, the official journal of the American Society of Plastic Surgeons. IBWM provides an environment where the body can rebuild the layers of the skin supporting the healing process. In areas of the body where range of motion is important, IBWM helps patients get back to functioning and living as they did before the wound occurred. Yesterday, 200 surgeons from around the world attended an Integra LifeSciences webinar "Efficient & Effective Ways to Manage Lower Extremity Wounds." During this webinar, Drs. Kovach and Fischer presented their recently published data and shared their insights and strategies to help address the efficiency of operating room time and prioritization of procedures as operating rooms start to reopen during the COVID-19 pandemic. The first clinical publication reviews the efficacy of the Integra Bilayer Wound Matrix for lower extremity soft tissue reconstruction. With 70% of the wounds successfully salvaged at the 180-day timepoint, the authors were able to identify success factors across patient selection and wound types. The second publication reviewed cost and resource utilization comparing Integra Bilayer Wound Matrix, Local Tissue Rearrangement and Free Flap. This study showed significantly longer surgery time at 85 and 408 minutes for LTR and FF respectively, compared with 50 minutes for Integra Bilayer Wound Matrix. It also reported more than double the length of stay in the hospital for both LTR and FF versus Integra Bilayer Wound Matrix. Lastly, total cost of the surgery was $53,492 for FF, $35,220 for LTR and $34,877 for Integra Bilayer Wound Matrix. Given the shorter operating time and the potential lower cost, Integra Bilayer Wound Matrix may represent an opportunity for patients, surgeons and hospitals during the current situation.

08:08 EDT Hologic granted FDA EUA for second molecular test for COVID-19 - Hologic announced that it has received Emergency Use Authorization, or EUA, from the FDA for its Aptima SARS-CoV-2 assay to detect the novel coronavirus. The newly authorized test runs on Hologic's fully automated Panther system, more than 1,000 of which are already installed in clinical laboratories throughout the United States. Each Panther system can provide initial results in approximately three hours and process more than 1,000 coronavirus tests in 24 hours. Hologic has begun distributing its new coronavirus test, and expects to produce an average of one million tests per week. Combining significant manufacturing capacity for the new test with the world's largest installed base of high-throughput molecular instruments is expected to dramatically increase testing capabilities. The Panther system is a fully automated, high-throughput molecular diagnostic platform that is widely used around the world, with more than 1,800 systems installed in 60 countries. In the United States, instruments are installed across all 50 states. Approximately 750 U.S. hospital, public health and reference labs use the Panther system and its suite of Aptima assays to perform tens of millions of molecular tests annually for sexually transmitted infections, cervical cancer screening and viral load monitoring in people with HIV and hepatitis. Certain aspects of the Aptima SARS-CoV-2 assay project were conducted under a $13M contract, initially announced on April 29, 2020, with the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. Hologic plans to register its Aptima SARS-CoV-2 assay for a CE Mark for diagnostic use in Europe later in May.

08:05 EDT Essa Pharma presents new preclinical data on potential of EPI-7386 - ESSA Pharma presented new preclinical data on ESSA's clinical candidate, EPI-7386, at the 2020 Virtual American Urological Association Annual Meeting. The studies highlight new information about EPI-7386 including: In vitro cellular gene expression analyses demonstrate that EPI-7386: Inhibits androgen-induced genes with major similarities but some differences from enzalutamide in a cellular model sensitive to androgen receptor inhibitors. In the same cellular model, the combination of enzalutamide and EPI-7386 inhibits androgen-induced gene expression more completely and broadly. EPI-7386 shows superiority to enzalutamide in inhibiting androgen-induced genes in an androgen receptor resistant model, and in contrast to enzalutamide, also blocks genes induced by the AR-V7 androgen receptor splice variant. Toxicology studies evaluating the safety profile of EPI-7386 demonstrate that: Very high plasma exposures of EPI-7386 were achieved across all studies. The drug was well tolerated at both the low and middle doses, corresponding to drug plasma exposures 2-5 fold higher than the efficacious exposures achieved in mouse xenograft models. The highest doses tested were characterized as the HNSTD (highest non-severely toxic dose) and only exhibited body weight loss and reduced food consumption. The drug plasma exposures achieved at this high dose were 7-10 fold higher than the efficacious exposures achieved in mouse xenograft models. The starting clinical dose of EPI-7386 will be 200 mg given once-daily.

08:04 EDT Celsion says Phase III OPTIMA study on track for interim data analysis in July

07:56 EDT StorageVault raises quarterly dividend 0.5% to C$0.00268c per share - StorageVault is increasing its quarterly dividend by 0.5% beginning Q2 2020 to C$0.00268c per common share.

07:45 EDT Theratechnologies announces new data for investigational peptide-drug conjugates - Theratechnologies announced new results for its investigational Sortilin targeting peptide-drug conjugates which will be presented in three posters during AACR's virtual annual meeting II on June 22, 2020. Vasculogenic mimicry is the formation of microvascular channels in aggressive, metastatic and resistant cancers. Recently published studies indicate that the presence of VM is known to contribute to tumor progression, dissemination of cancer metastases and chemoresistance. It is associated with poorer prognosis in many types of aggressive cancers including ovarian and triple-negative breast cancers. Results indicate that, in vitro, TH1904 stopped the formation of VM in an ovarian cancer model at very low doses whereas doxorubicin alone had no effect. Strong inhibition of VM in a triple-negative breast cancer model was also observed with very low doses of TH1902 compared to docetaxel alone. The abstract "Sortilin receptor-mediated novel cancer therapy: A targeted approach to inhibit VM in ovarian and breast cancers" is now available online at aacr.org. Various phytochemicals found in plants, such as curcumin, have been shown to have antiproliferative, antiangiogenic and apoptotic properties against various cancers such as colorectal, ovarian and breast cancers. Curcumin was conjugated to Theratechnologies' investigational SORT1 targeting peptide. TH1901 was tested for its anti-proliferative effect against various cancer cells in vitro and compared to the effect of unconjugated curcumin. Results indicate that TH1901 has up to 100 times greater anti-proliferation activity against cancer cells than curcumin. In addition, TH1901 induced cell apoptosis and it had a stronger effect on TNF-induced intracellular signaling pathways involved in pro-inflammation processes compared to curcumin alone. Theratechnologies is currently evaluating the further development of TH1901. The abstract "TH1901, a novel Curcumin-peptide conjugate for the treatment of Sortilin-positive cancer" is now available online at aacr.org. TH1902 induced complete tumor regression in Triple-Negative Breast Cancer with no apparent decrease in neutrophil count. Triple-negative breast cancer, which represents approximately 10 to 20% of breast cancers, does not express estrogen receptors, progesterone receptors or human epidermal growth factor receptor 2. It is more aggressive than other breast cancers. It has been observed that TNBC overexpresses SORT1 receptors. TH1902 was tested in vivo to assess its effect on TNBC compared to docetaxel alone. Results indicate that docetaxel administered alone at one quarter of its maximum tolerated dose had no apparent effect on tumor burden in a mouse model. In contrast, TH1902 administered at a comparable dose led to strong and sustained tumor inhibition. TH1902 has also demonstrated a better safety profile than the administration of docetaxel alone. While a single 15mg/kg dose of docetaxel induced neutropenia, no apparent change in neutrophil counts was observed in mice treated with equivalent doses of TH1902 for up to 6 cycles. The abstract "A novel Sortilin-targeted docetaxel peptide conjugate for the treatment of Sortilin-positive triple-negative breast cancer" is now available online at aacr.org.

07:43 EDT Surface Oncology to present preclinical data for multiple product programs - Surface Oncology announced five scientific posters sharing updated preclinical data at the American Association for Cancer Research 2020 Annual Meeting, to be held virtually on June 22-24. The posters include preclinical data from Surface Oncology's two lead clinical-stage antibody therapies: SRF617 and SRF388. Three additional posters containing preclinical data from SRF813 and SRF231 will also be presented. Title: SRF617, a potent enzymatic inhibitor of CD39, demonstrates single-agent activity and cooperates with various cancer therapies in both solid tumor and hematologic malignancies: SRF617 is a potent inhibitor of CD39 enzymatic activity both in vitro and in vivo. Inhibition of CD39 potentiates the activity of chemotherapy and immunotherapy agents to improve tumor growth inhibition and survival in mice. Differential CD39 expression patterns across tumor types inform clinical indication selection. These findings support future clinical studies of SRF617 as monotherapy and in combination with other therapeutic agents in treating patients with cancer. Title: Increased IL-27 is associated with poor prognosis in renal cell carcinoma and supports use of SRF388, a first-in-class IL-27p28 blocking antibody, to counteract IL-27-mediated immunosuppression in this setting: IL-27 is a heterodimeric cytokine consisting of 2 subunits that limits the intensity and duration of T cell-mediated immunity. High levels of IL-27p28, EBI3, and IL27RA transcript levels are often elevated in renal cell carcinoma tumors and are associated with poor clinical outcome. SRF388 inhibits IL-27 signaling, diminishes inhibitory receptor expression and increases cytokine production. This pro-inflammatory response is enhanced when combined with PD-1 blockade. Data from these studies indicate that blockade of IL-27 can potentiate anti-tumor responses by counteracting IL-27-mediated immune escape. Title: SRF813, a fully human monoclonal antibody targeting the inhibitory receptor CD112R, enhances immune cell activation and anti-CD112R treatment in vivo demonstrates preclinical anti-tumor activity: SRF813 inhibits the CD112-CD112R interaction and enhances NK cell activation. CD112R inhibition in mouse tumor models reduced tumor growth and increased tumor-infiltrating lymphocyte activation. The combination of anti-CD112R with PD-1 blockade leads to greater tumor growth inhibition than either treatment alone. These preclinical data demonstrate that CD112R is a negative regulator of immune responses and that CD112R inhibition can potentiate anti-tumor responses in cancers that express CD112. Title: SRF231, a fully human CD47 antibody, potentiates the effects of opsonizing antibodies and cytotoxic chemotherapies in preclinical cancer models: SRF231 demonstrates anti-tumor activity as a monotherapy in multiple myeloma and non-small cell lung cancer models. SRF231 potentiates the effects of opsonizing antibodies in preclinical MM xenograft models. SRF231 potentiates the effects of taxane and platinum-based standard of care chemotherapies in preclinical NSCLC xenograft models. Title: The anti-CD47 antibody SRF231 increases anti-tumor activity of standard of care chemotherapy in platinum-resistant PDX models of ovarian cancer: Anti-CD47 directed therapy with SRF231 demonstrates the ability to significantly increase the anti-tumor activity of standard chemotherapies in xenograft and platinum-resistant patient-derived xenograft models of ovarian cancer. In 2018, Surface Oncology deprioritized the SRF231 clinical program and is concluding its Phase 1 study.

07:39 EDT ContraFect experiences delays in patient enrollment for Phase 3 DISRUPT study - During the quarter ended March 31, 2020, the novel coronavirus disease, COVID-19, was declared a pandemic and spread to multiple regions across the globe, including the United States and Europe. The outbreak and government measures taken in response have impacted, both directly and indirectly, the Company's business. The full extent of the impact to the Company's business, results of operations and financial condition, including expenses, research and development costs and clinical trial progress will depend on future developments that are highly uncertain, including as a result of new information that may emerge. The Company has adjusted its business operations in response to COVID-19, with a majority of its employees working remotely, and as a result, incurred some delays in certain research activities. COVID-19 has not affected the Company's supply chain or its ability to supply the Phase 3 DISRUPT study of exebacase. Patient enrollment is ongoing and clinical trial sites continue to open since the Phase 3 DISRUPT trial has potential for significant benefit in Staph aureus bacteremia, a serious and life-threatening condition. The Company has experienced some delays in new patient enrollment in the Phase 3 DISRUPT study due to the diversion of healthcare resources resulting from the COVID-19 pandemic in certain high impact areas. The Company will continue to monitor the potential impacts of COVID-19 on its business.

07:36 EDT Aprea targets first patient enrollment in Phase 1/2 solid tumor trial in 2H20 - Based on in vivo data evidencing synergistic activity between APR-246 and immuno-therapy agents including anti-PD-1 antibody, the Company has designed and plans to conduct Phase 1/2 clinical trials in relapsed/refractory gastric, bladder and non-small cell lung cancers assessing APR-246 with anti-PD-1 therapy. The Company is targeting the first patient to be enrolled in the second half of 2020.

07:35 EDT Aprea Therapeutics targets first patient enrollment in Phase 1 NHL trial in 2H20 - As further assessment of APR-246 in hematological malignancies, the Company has designed and plans to conduct a Phase 1 clinical trial in relapsed/refractory TP53 mutant chronic lymphoid leukemia and mantle cell lymphoma assessing APR-246 with venetoclax and rituximab, and APR-246 with ibrutinib. The Company is targeting the first patient to be enrolled in the second half of 2020.

07:33 EDT Aprea Therapeutics expects to close enrollment in Phase 3 MDS trial in 2Q20 - The Company is currently enrolling a pivotal Phase 3 randomized, controlled trial evaluating APR-246 with azacitidine as frontline therapy in HMA-naive TP53 mutant myelodysplastic syndromes patients with a primary endpoint of CR rate. Though the Company had initially observed a decrease in both patient screening and patient enrollment as a result of the coronavirus pandemic, the Company has recently observed increased patient screening activity and has currently enrolled 140 patients in the trial with a number of additional patients now scheduled for screening. The Company currently plans to close enrollment of this trial in the second quarter of 2020 and remains confident it will have top-line data available by year-end 2020.

07:32 EDT Red Lion Hotels CFO Nate Troup to depart - Red Lion Hotels Corporation (RLH), announced that its current CFO Nate Troup is leaving the Company to join Twilio (TWLO) as its VP, Global Controller. Troup's last day with the Company will be May 29, 2020. RLHC has engaged Gary Kohn, a financial consultant with extensive public company CFO experience, to support RLHC during the transition and until a replacement can be identified. The Company believes it has a strong finance team in place to work with Kohn and expects a smooth transition. Mr. Kohn will join RLHC effective May 18, 2020. The Company intends to promptly conduct a search for a permanent CFO, and Gary Kohn will be considered along with other candidates identified.

07:30 EDT Vicor Corporation launches new high-performance chip-set options - In a press release yesterday, Vicor Corporation announced a ChiP-set for high performance GPU, CPU, and ASIC processors powered directly from 48V. A driver, MCD4609, and a pair of MCM4609 current multiplier modules supply up to 650A continuous and 1,200A peak. Powering GPU and OCP Accelerator Module Artificial Intelligent cards, the 4609 ChiP-set is in mass production and available to new customers on the Vicor Hydra II evaluation board.

07:29 EDT Medigus signs agreement with Elbit Systems for distribution of ventilators - Medigus (MDGS) announced the signing of an exclusive distribution agreement with Elbit Systems Land, a subsidiary of Elbit Systems (ESLT) for a period of one year. Elbit Systems manufactures LifeCan, an innovative pandemic response ventilator. As part of the agreement, Medigus will obtain exclusive rights from Elbit Systems, for marketing and sale of this product to customers in Mexico. Medigus will be responsible for obtaining and maintaining licenses and approvals required by the Mexican regulations, including health administration authorities. In order to start the regulatory process, Medigus acquired two LifeCan systems that will assist the company in obtaining the required permits for the marketing and selling of the ventilators.

07:26 EDT CareDx receives CE Mark approval for AlloSeq Tx 17 - CareDx announced that it had received the CE mark approval for AlloSeq Tx 17, making it broadly available to transplant patients, laboratories and clinicians around the world. AlloSeq Tx 17 is the best in class solution for matching transplant donor organs to recipients, utilizing next generation Hybrid Capture technology for HLA testing. CareDx launched this novel technology during the American Society for Histocompatibility and Immunogenetics and BANFF Foundation for Allograft Pathology's Joint meeting September 2019.

07:23 EDT Molecular Templates to present data on engineered toxin bodies - Molecular Templates announced that new preclinical data on its pipeline programs and technology platform will be presented at the AACR Virtual Annual Meeting II to take place June 22-24, 2020. All four posters are expected to be available on the AACR website on June 22, 2020. Title: In Vivo Efficacy of a PD-L1 Targeted, Antigen Seeding Engineered Toxin Body: MT-6402 is a highly differentiated approach to immuno-oncology. MT-6402 target PD-L1 and has been shown in preclinical studies to induce three unique biological effects: Unlike current checkpoint inhibitors which bind PD-L1 and block interactions, MT-6402 directly destroys PD-L1+ tumor cells. MT-6402 can deliver foreign viral antigens into the target tumors to uniquely alter their immunophenotype to make them visible to CMV-reactive CD8+ T-cells. MT-6402 clears PD-L1+ immune cells and thereby potently activates the immune system. Non-human primate data presented at the AACR meeting show that MT-6402 mediated PD-L1+ immune cell clearance can elicit highly potent monotherapy immune activation in a way that has not been seen previously in NHP models with checkpoint inhibitors. Title: CTLA-4 Targeted Engineered Toxin Bodies Designed to Deplete Regulatory T Cells: Tumor resident regulatory T cells are important mediators of an immunosuppressive tumor microenvironment promoting tumor immune evasion. The presence of Tregs, and a higher ratio of Tregs to effector T cells in the TME, are associated with poor prognosis. There is concern that antibodies to CTLA-4 are not sufficiently effective at clearing Tregs from the TME. ETBs are being developed to specifically target CTLA-4+ Tregs and clear them from the TME. The clearance of Tregs in the TME is expected to re-expose the tumor to the immune system to allow for tumor control. Because CTLA-4-targeted ETBs preferentially affect Tregs versus CTLA-4+ CD8 T-cells, ETBs may also have a safer profile than CTLA-4 antibodies. Title: Novel Engineered Toxin Bodies Targeting SLAMF7: SLAMF7 is a clinically validated target of monoclonal antibody therapy for the treatment of multiple myeloma. The approved antibody-based therapeutic, elotuzumab, works indirectly by recruiting effector cells to the tumor but does not show single agent clinical activity. ETBs have the potential to deplete malignant cells by means of potent and direct cell kill through enzymatic ribosomal destruction. Title: CD45 Targeted Engineered Toxin Bodies Deplete Hematopoietic and Malignant Cells: CD45, the leucocyte common antigen, is a haemopoietic cell-specific tyrosine phosphatase. Targeted and potent ETBs with intrinsically short half-lives are being developed to specifically destroy CD45 expressing cells including malignant cells of B, T and myeloid lineage. A single agent, targeted conditioning method for bone marrow transplant, employing ETBs, has the potential to increase patient safety and eliminate genotoxic effects that are associated with existing conditioning regimens.

07:19 EDT DraftKings updates on U.S. sports betting legislation, capitalization - DraftKings stated along with its report of first quarter results: "At this time, approximately 14 U.S. states are actively considering sports betting legislation and DraftKings expects this momentum to continue as governments begin to focus on reopening the economy. States that have passed legislation to permit online sports betting over the past year include Illinois, Michigan, Tennessee and Virginia. In Q1 2020, DraftKings launched retail and online sports betting in Iowa, and recently went live with iGaming in Pennsylvania and online sports betting in Colorado. After the successful business combination and public listing on April 24th, DraftKings is well capitalized with nearly half a billion dollars of cash on the balance sheet."

07:18 EDT DraftKings does not anticipate impact to FY21 or long-term due to COVID-19 - DraftKings stated along with its report of first quarter results: "DraftKings continues to make progress on its key priorities despite the effects of the COVID-19 pandemic. These include entering new states, investing in product and technology to create more unique offerings and live betting for American-based sports, and acquiring and retaining our customers. The company has responded to the lack of major sports by creating new product offerings that are keeping customers engaged, such as fantasy sports and betting on eNASCAR, Counter Strike, and Rocket League. DraftKings has also launched a series of pop culture free-to-play pools contests that cover topics from democratic debates to TV shows like Survivor, The Last Dance and Top Chef. DraftKings also recently partnered with MLB on their new MLB Dream Bracket game. The company does not anticipate an impact to FY2021 or long-term plans due to COVID-19."

07:16 EDT Zentalis expects cash to fund operations into 2022 - The company said, "As of March 31, 2020, Zentalis had cash and cash equivalents of $63.7 million. We expect that the Company's existing cash and cash equivalents, together with the net proceeds of $172.4 million from the IPO, will enable the Company to fund its operating expenses and capital expenditure requirements into 2022."

07:09 EDT VF Corp. down 7% to $51.45 after Q4 results missed estimates - The company also guided Q1 revenue 'down slightly more than 50%,' consensus $1.31B.

07:07 EDT Precision BioSciences has not experienced material delays to trials - In April 2020, Precision provided an update regarding its clinical trials and business operations amid the COVID-19 pandemic. This includes steps taken in line with guidance from public health officials to protect the health and safety of its employees and to ensure continuity of its clinical trials. Precision's work-from-home policy and restriction of on-site activities to certain manufacturing functions and limited laboratory and support activities remain in effect. To date, Precision has not experienced material delays to its planned or ongoing clinical trials.

07:06 EDT Air Products, Haldor Topsoe sign global alliance agreement - Air Products and Haldor Topsoe announced the signing of a global Alliance Agreement. The two companies will collaborate, using their extensive market network outreach for developing potential projects and the combination of their expertise on large-scale ammonia, methanol and/or dimethyl ether plants to be developed and built globally. The Alliance Agreement provides Air Products access to Topsoe's technology license(s) and the supply of certain engineering design, equipment, high-performance catalysts and technical services for ammonia, methanol and/or dimethyl ether plants to be built, owned and operated by Air Products. The collaboration allows for the integration of Topsoe's technology into many Air Products' technologies including gasification of various feedstocks, and synthesis gas processes.

07:05 EDT Precision BioSciences expects data from PBCAR0191 trial in 2020 - PBCAR0191 is an investigational allogeneic CAR T candidate targeting CD19, currently being evaluated in a Phase 1/2a study in relapsed or refractory non-Hodgkin lymphoma or R/R B-cell precursor acute lymphoblastic leukemia. The NHL cohort will include patients with mantle cell lymphoma, an aggressive subtype of NHL, for which Precision has received Orphan Drug Designation from the U.S. Food and Drug Administration. In the first quarter of 2020, after discussion with the FDA, Precision implemented an amendment to the PBCAR0191 trial protocol designed to further optimize clinical activity. The amended trial design is intended to specifically address key clinical questions, which include assessing the impact of higher total doses of cells on clinical activity and/or the impact of modified lymphodepletion on the ability to achieve durable clinical benefit with associated CAR T cell expansion and persistence. The PBCAR0191 clinical trial continues to progress, and no dose limiting toxicities or serious adverse events have been observed to date. Precision expects to present updated interim clinical data from both the NHL and B-ALL cohorts of this trial during 2020. PBCAR0191 is being developed in collaboration with Servier, an international pharmaceutical company.

07:04 EDT Precision BioSciences says cash, cash equivalents to fund operations into 2H21 - As of March 31, 2020, Precision had approximately $154.2 million in cash and cash equivalents. The Company expects that existing cash and cash equivalents will be sufficient to fund operating expenses and capital expenditure requirements into the second half of 2021.

06:58 EDT VF Corp. 'currently not contemplating' suspension of dividend - On May 12, VF's Board of Directors declared a quarterly dividend of 48c per share. This dividend will be payable on June 22 to shareholders of record on June 10. Subject to approval by its Board of Directors, VF intends to continue to pay its regularly scheduled dividend and is currently not contemplating the suspension of its dividend program.

06:45 EDT CSL, Bayou withdrew this week $6 per share offer for Ranger Energy - CSL Capital Management and Bayou Well Holdings Company withdrew earlier this week their preliminary non-binding offer submitted to Ranger Energy's board on March 12 for the acquisition of all of the outstanding publicly held shares of common stock not already owned in exchange for $6.00 in cash per share. In a letter to Ranger disclosed in a regulatory filing on May 12, CSL and Bayou said, "After much discussion, CSL Capital Management, L.P. and Bayou Well Holdings Company, LLC have determined not to pursue the possible acquisition of all of the outstanding publicly held shares of common stock of Ranger Energy Services, Inc. at this time, given the current macroeconomic environment and the volatility in the upstream oil and gas sector. We are therefore withdrawing our Non-Binding Offer effective immediately. We appreciate the careful consideration the Special Committee of the Ranger Board of Directors has given to our Non-Binding Offer over the past several weeks and for its time and attention in evaluating such. We are committed to our ongoing investment in Ranger and look forward to continued discussions about the future of Ranger with the Board of Directors of Ranger."

06:39 EDT PBF Energy provides business update amid COVID-19 pandemic - The company said, "The recent outbreak of the COVID-19 pandemic and certain developments in the global oil markets are negatively impacting worldwide economic and commercial activity and financial markets, as well as global demand for petroleum and petrochemical products. The COVID-19 pandemic and related governmental responses have also resulted in significant business and operational disruptions, including business closures, supply chain disruptions, travel restrictions, stay-at-home orders and limitations on the availability of workforces and has resulted in significantly lower demand for refined petroleum products. We are actively responding to the impacts from these matters on our business. In late March and through early April 2020, we started reducing the amount of crude oil processed at our refineries in response to the decreased demand for our products and we temporarily idled various units at certain of our refineries to optimize our production in light of prevailing market conditions. In March 2020, we announced initial expense reduction efforts that should result in a reduction in our 2020 operating expenses of approximately $125 million. We have subsequently identified additional reductions and currently estimate an aggregate reduction of approximately $140 million in our 2020 operating expenses budget. In addition, we are currently operating our refineries at minimum rates, a throughput reduction of approximately 30% versus our previous expectations. As the market conditions develop and the demand outlook becomes clearer, we will continue to adjust our operations, regionally and in total, in response. We expect near-term throughput to be in the 650,000 to 750,000 barrel per range for our refining system. In addition to the steps above with respect to our operations, we are taking the following measures, some of which were previously announced in March 2020: Increased precautions to keep our employees healthy and safe, including social distancing, additional personal protective equipment and enhanced facility cleanings. We have not had to temporarily close any of our refineries due to a COVID-19 outbreak; Reduced 2020 planned capital expenditures by a total of more than $350 million, an increase from our originally announced $240 million reduction. This is an estimated aggregate reduction of approximately 50% to our previous 2020 budget. Early in the second quarter, PBF completed its only major turnaround activity for 2020 at its Toledo refinery. We intend to satisfy all required safety, environmental and regulatory capital commitments, while continuing to explore further opportunities to minimize our near-term capital expenditure requirements; Reduced corporate overhead expenses by over $20 million on an annual basis primarily through salary reductions; Suspended PBF Energy's quarterly dividend of $0.30 per share, anticipated to preserve approximately $35 million of cash each quarter; and Evaluating various other liquidity and cash flow optimization options."

06:36 EDT Centogene CBO Oved Amitay to step down, Sun Kim to succeed - Centogene announced that Oved Amitay will be stepping down as Chief Business Officer and leaving the company effective May 31. He will be succeeded by Sun Kim, the current Chief Strategy and IR Officer, who will assume Amitay's responsibilities as CBO until a permanent CBO has been appointed. Amitay will continue his work for rare diseases patients in the non-profit sector, where he will serve as CEO of a patient advocacy organization.

06:14 EDT Capital One reports April net charge-offs 4.93% - Reports April 30-plus day performing delinquencies 3.58%.

06:05 EDT Orchard Therapeutics presents new data from OTL-203 study for MPS-I - Orchard Therapeutics announced new interim data from an ongoing proof-of-concept clinical trial evaluating the safety and efficacy of OTL-203, an ex vivo autologous hematopoietic stem cell gene therapy in development for the treatment of mucopolysaccharidosis type I at the San Raffaele Telethon Institute for Gene Therapy in Milan, Italy. "We have made strong progress with the MPS-I clinical trial and are pleased to see these interim results, with all patients achieving hematological recovery in less than 45 days - a primary outcome measure - as well as supraphysiological levels of IDUA enzyme in the blood. In addition, the trial results to date have shown promising preliminary clinical effects on motor skills, IQ and growth in the first two patients with 12 and 18 months of follow-up," said Maria Ester Bernardo, M.D., Ph.D., co-principal investigator at SR-Tiget. "We also observed reconstitution of enzyme activity in the cerebral spinal fluid in the first two treated patients with 12 months of follow-up, complemented by a decrease in glycosaminoglycan levels in the CSF. We look forward to continuing to assess the outcomes of this investigational gene therapy for patients with this often-fatal condition."

05:19 EDT China XD Plastics special committee engages financial advisor, legal counsel - China XD Plastics announced that the special committee consisting of independent directors of its board, formed to consider, among other things, the previously announced preliminary non-binding "going private" proposal received by the board on May 8, has retained Duff & Phelps as its financial advisor and Hogan Lovells as its legal counsel to assist it in its review and evaluation of the proposed transaction.

05:12 EDT SSR Mining divests SilverCrest Metals equity position for C$90M - SSR Mining (SSRM) announced that it has completed an on-market transaction to divest 9,000,645 common shares of SilverCrest Metals (SILV) at a price of C$10.06 per share for gross proceeds of approximately C$90M. Following the transaction SSR Mining does not hold any SilverCrest shares.