Stockwinners Market Radar for May 11, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:51 EDT Adamis Pharmaceuticals reacquiring rights to SYMJEPI injection - Adamis Pharmaceuticals announced it is reacquiring from Sandoz Inc. the rights to its SYMJEPI, or epinephrine, injection 0.3mg, and SYMJEPI injection 0.15mg products currently marketed and available in the United States. Adamis has simultaneously entered into an exclusive distribution and commercialization agreement with US WorldMeds, LLC for the United States commercial rights for the SYMJEPI products, as well as its ZIMHI, or naloxone HCI Injection, USP, 5mg/0.5mL product candidate. Adamis and Sandoz have entered into an agreement providing for the mutually agreed return to Adamis of the marketing, promotion, and distribution rights of the SYMJEPI products, and the termination of the commercialization agreement between Adamis and Sandoz, following a transition period, supported by a transition services agreement that is currently being negotiated. As part of the termination agreement, Sandoz will continue to support the products in the U.S. under the existing commercialization agreement through the end of the transition period to help minimize any potential impact to patients and customers. Under the terms of the Adamis/US WorldMeds agreement, US WorldMeds obtained U.S. rights to commercialize and distribute the SYMJEPI products, upon the termination of Sandoz' commercial rights, and ZIMHI, if approved by the FDA, in exchange for an upfront payment and potential regulatory and commercial milestones totaling up to $26M. Additionally, after deducting the supply price and certain other deductions, including an allocation for US WorldMeds sales and distribution expenses from net sales of the products, Adamis and US WorldMeds will share equally in the net profits, as defined in the agreement.

19:27 EDT Activision Blizzard director sells 24K shares of common stock - In a regulatory filing, Activision Blizzard disclosed that its director Collister Johnson sold 24K shares of common stock on May 7th in a total transaction size of $1.74M

18:23 EDT Match Group's McDaniel sells 9,000 common shares - In a regulatory filing, Match Group director Ann McDaniel disclosed the sale of 9,000 common shares of the company on May 7 at a price of $85.9711 per share.

17:43 EDT Unisys awarded $630M Air Force TADS contract - Unisys has been awarded a $630M single-award, indefinite-delivery/indefinite-quantity contract for technology application development and sustainment, or TADS, supporting the Air Force weather enterprise. Orders under the TADS contract will support development, delivery and sustainment of an integrated system of weather enterprise hardware and software dedicated to providing accurate, consistent, relevant and timely environmental intelligence. Work will be performed at Offutt Air Force Base, Nebraska and Omaha, Nebraska, and is expected to be completed by October 15, 2025. This award is the result of a competitive acquisition and six proposals were received. FY20 operations and maintenance funds in the amount of $2.18M are being obligated at the time of award. The 55th Contracting Squadron is the contracting activity.

17:41 EDT Acer Therapeutics enters research pact with NCATS for emetine hydrochloride - Acer Therapeutics announced it has entered into a research collaboration agreement with the National Center for Advancing Translational Sciences, or NCATS, one of the National Institutes of Health, or NIH, to develop emetine hydrochloride as a potential treatment for patients with COVID-19, the disease caused by infection with the SARS-CoV-2 virus. Under the terms of the agreement, Acer and NCATS will collaborate to accelerate the clinical development of emetine, a broad-acting and potent antiviral according to various preclinical and clinical studies. Acer is in ongoing discussion with the Division of Antivirals, or DAV, at the FDA after receiving its initial written responses to the company's pre-IND package. Acer is working toward an IND submission in mid-2020 and targeting clinical trial initiation in Q3, subject to additional capital. The company has proposed an adaptive design Phase 2/3 randomized, blinded, placebo-controlled multi-center trial to evaluate the safety and antiviral activity of emetine in high-risk, symptomatic adult patients with confirmed COVID-19 infection not requiring hospitalization. The trial objectives as planned are to determine the safety and efficacy of emetine via clinical status at a specific timepoint in addition to disease resolution. Acer is concurrently pursuing several financing options, including federally-funded research and grants, to support emetine development. For example, the Biomedical Advanced Research and Development Authority, or BARDA, invited the company to present the emetine development program at the BARDA CoronaWatch meeting on May 7. BARDA CoronaWatch is a funding program providing government support for selected coronavirus projects. While Acer plans to advance emetine through IND submission, initiation of the clinical trial of emetine is contingent on the timely availability of additional capital to fund this program. Emetine will be delivered as a sterile subcutaneous injection. Acer will oversee the contract synthesis and manufacturing of emetine for clinical development and potential commercialization.

17:30 EDT Calavo Growers appoints Kevin Manion as CFO - Calavo Growers announced that Kevin Manion has been appointed CFO. Prior to joining Calavo, Manion held financial leadership positions with a number of companies. In these roles, he supported revenue growth, efficiency and profitability initiatives, inventory management, treasury and capital markets activities, mergers and acquisitions, strategic and financial planning and investor relations.

17:17 EDT GameStop urges holders to vote in support of its director nominees - GameStop issued a letter to stockholders reiterating its "history of extensive engagement with all stockholders," including Hestia Capital Partners, LP and Permit Capital Enterprise Fund, LP, and outlining the "significant steps it has taken to comprehensively refresh its Board, management team, and corporate governance practices within the last two years." The letter urges stockholders to use the BLUE proxy card to vote "FOR ALL" of GameStop's 10 highly qualified director nominees in connection with the Company's upcoming Annual Meeting of Stockholders to be held at 8:00 a.m. CT on June 12, 2020. "GameStop's capital allocation and operationally-driven working capital strategy have directly enabled us to navigate the COVID-19 pandemic with increased financial flexibility, a stronger balance sheet, and sufficient liquidity to protect and enhance stockholder value," the letter reads. "As you consider how to vote your shares, we urge you to consider the disastrous financial position the Company would be in today had your Board pursued the Dissident Stockholders' short-term focused and self-serving buyback strategy." "We believe that GameStop's highly qualified and experienced Board of Directors is best-positioned to oversee the continued successful execution of GameStop's Reboot plan and deliver substantial value to ALL of our stockholders," the letter continues. "On behalf of the Board of Directors and our management team, thank you for your continued support and your investment in GameStop."

17:14 EDT Caesars says Louisiana casinos could open this coming weekend

17:08 EDT Green Dot rallies 12.4% after-hours following Q1 earnings beat

17:06 EDT Artisan Partners reports AUM $106.8B as of April 30 - Artisan Partners Asset Management reported that its assets under management as of April 30, 2020 totaled $106.8 billion. Separate accounts accounted for $56.9 billion of total firm AUM, while Artisan Funds and Artisan Global Funds accounted for $49.9 billion.

17:02 EDT Jianpu Technology discloses NYSE listing compliance notice - Jianpu Technology announced that it has received a letter from the NYSE dated April 13, 2020 and further e-mail communication on April 23, 2020, notifying the company that (i) it is below compliance standards due to the trading price of company's American depositary shares and (ii) the applicable cure period for the company to regain compliance expires on December 22, 2020. To address this issue, Jianpu intends to monitor the market conditions of its listed securities and is still considering its options.

16:58 EDT Invesco reports preliminary AUM $1.12T as of April 30th - Invesco reported preliminary month-end assets under management of $1.12T, an increase of 6.2% versus previous month-end. The firm achieved net inflows of $0.4 billion this month. Net inflows were driven by a $5.8 billion increase in money market AUM and net long-term inflows in the institutional business of $1.6 billion, due to the funding of several client mandates, including the continued partial funding of a previously disclosed Solutions win. Overall net long-term outflows were $4.9 billion and non-management fee earning outflows were $0.6 billion.

16:56 EDT AllianceBernstein reports preliminary AUM $576B as of April 30 - AllianceBernstein announced that preliminary assets under management increased to $576B during April 2020 from $542B at the end of March. The 6.3% increase was due to market appreciation, as well as firmwide net inflows. By channel, Retail and Institutions experienced positive net flows, while Private Wealth experienced outflows. April month-end AUM also reflected $0.3 billion in outflows resulting from AXA S.A.'s redemption of certain low-fee fixed income mandates.

16:54 EDT Caesars sees regional markets bouncing back more quickly - Says focused on preserving liquidity. Sees regional markets bouncing back more quickly. Says seeing some "encouraging" statistics and information as it looks at the fourth quarter. Says had a "pretty significant" bump in reservations recently following Nevada governor's updates and the Las Vegas Raiders releasing their schedule.

16:50 EDT Cara Therapeutics sees cash sufficient through second half of 2021 - The company said, "Based on timing expectations and projected costs for current clinical development plans, Cara expects that its existing cash and cash equivalents and available-for-sale marketable securities as of March 31, 2020 will be sufficient to fund its currently anticipated operating expenses and capital expenditures into the second half of 2021, without giving effect to any potential milestone payments under existing collaborations."

16:47 EDT Hertz drops 5% to $3.04 after issuing doubt on remaining going concern

16:46 EDT Hertz sees 'substantial doubt' on remaining going concern within one year - Hertz said today in its quarterly filing with the SEC, "Management has determined that the Company may not be able to repay or refinance its debt facilities prior to their respective maturities and may not have sufficient cash flows from operations or liquidity to sustain its operating needs or to meet the Company's obligations as they become due over the twelve months following this Quarterly Report on Form 10-Q. As such, management has concluded there is substantial doubt regarding the Company's ability to continue as a going concern within one year from the issuance date of this Quarterly Report on Form 10-Q. The Company's consolidated financial statements as of March 31, 2020 have been prepared on a going concern basis."

16:43 EDT Concrete Pumping provides liquidity, cash preservation effort update - The company said, "Given the current impact of COVID-19, CPH has prioritized its liquidity and cash preservation. Net debt1 in the second fiscal quarter is expected to be reduced by approximately $19.2 million compared to the first quarter of fiscal year 2020 to approximately $413.7 million. Highlights of the various liquidity improvements and cost saving measures enacted include: Cash preservation initiatives resulting in approximately $32.0 million of total available liquidity as of April 30, 2020, between cash on the balance sheet and availability from the ABL revolver. Suspension of uncommitted 2020 capex investment. Disciplined control of highly variable cost structure - approximately 70% of the Company's cost base is variable, insulating its cost structure from potential demand shocks experienced as a result of COVID-19."

16:38 EDT Aimmune says COVID-19 has paused launch of Palfozia - Aimmune Therapeutics said in its earnings release, "The COVID-19 pandemic has paused the commercial launch of PALFORZIA. Under the Risk Evaluation and Mitigation Strategy, or REMS, for PALFORZIA, the first dose of each up-dosing level must be administered in a certified healthcare setting and, due to the strains placed on the providers of healthcare services by COVID-19, including shelter-in-place restrictions, many patients are not able to access physicians in a manner sufficient to commence treatment with PALFORZIA. Similarly, patients who have commenced treatment, but who have not yet advanced through the up-dosing phase, have been restricted from accessing the necessary healthcare settings and, as a result, are being maintained at their existing dose levels. To date, our commercial and clinical supply chain for PALFORZIA has not been significantly impacted to date by the COVID-19 pandemic. There have been no disruptions in our supply chain of drug manufacturers necessary to conduct our clinical trials, and we believe that we will be able to supply the clinical material needs of our ongoing clinical studies. We are ready to support allergists and their practices to continue initiating new patients on PALFORZIA therapy as soon as they are ready to reopen their practices."

16:35 EDT Genfit sinks 66% to $7.30 after Phase 3 NASH trial failure

16:34 EDT Durect jumps 14% to $2.54 after announcing Phase 2 COVID-19 study plans

16:32 EDT Franklin Resources reports preliminary AUM of $599.4B at April 30, 2020 - Franklin Resources reported preliminary month-end assets under management of $599.4 billion at April 30, 2020, compared to $580.3 billion at March 31, 2020. The increase in assets under management was due to strong market performance and significant improvement in net outflows. Preliminary average assets under management for the quarter, through April 30, 2020, were $589.8 billion.

16:31 EDT Durect sees alcoholic hepatitis trial enrolling in second half of 2020 - The company said, "We are working with the FDA and our advisors to finalize the design of a multi-center, international, randomized, double blind, placebo-controlled Phase 2b clinical trial of DUR-928 in severe AH patients. Patients in the trial will be randomized to receive 30 mg of DUR-928, 90 mg of DUR-928 or placebo. The primary goal of the trial will be to demonstrate a superior survival rate for patients treated with DUR-928 compared to those treated with placebo. Further details of the trial design, including the size of the trial and details on the endpoints will be provided at a future date. Due to the COVID-19 pandemic, we are updating our guidance for initiation of this trial and now expect the trial to begin enrolling patients in the second half of 2020.

16:30 EDT Durect working with FDA on Phase 2 study of DUR-928 in COVID-19 patients - Durect said it is working with the FDA on the design of a double-blind, placebo-controlled, multi-center, proof-of-concept Phase 2 study to evaluate the safety and efficacy of DUR-928 in approximately 80 COVID-19 patients with acute liver or kidney injury. It said, "Coronavirus disease 2019 is an infectious disease caused by severe acute respiratory syndrome coronavirus. The rapid spread of the disease has resulted in a pandemic with more than 4 million confirmed cases and over 280,000 deaths worldwide, over 79,000 of which have occurred in the United States as of this writing. While most cases result in mild symptoms, including fever, cough and shortness of breath, some progress into severe pneumonia and multi-organ failure, potentially as a result of severe immune overreaction, or as a result of ischemic injury, or other complications. Several studies reported that up to half of hospitalized patients with COVID-19 had elevated liver enzyme levels that signal liver injury and more than a third of hospitalized patients had kidney damage...DUR-928 has demonstrated, both in vitro and in vivo, its ability to stabilize mitochondria, modulate inflammatory responses, and promote cell survival and tissue regeneration, which may render it to be effective in preventing or treating acute organ injury. Patients with severe COVID-19 can develop multi-organ injury, including acute kidney, liver and/or cardiac injury, in addition to lung injury and acute respiratory distress syndrome. Therefore, one could potentially save lives of those hospitalized patients with COVID-19 if one could prevent or treat acute organ injury by alleviating acute cell injury, regulating inflammation, promoting cell survival, and stimulating tissue regeneration."

16:28 EDT Cumberland says Vibativ sustained potency confirmed in two studies - Cumberland Pharmaceuticals announced two new publications detailing the sustained in vitro potency of Vibativ as part of a seven-year antimicrobial surveillance program. Both publications were part of continued surveillance of telavancin activity since 2011. The first publication tested a global collection of 24,408 Gram-positive clinical isolates, and the second publication tested a U.S. collection of 15,882 S. aureus isolates. All isolates were collected from the SENTRY Antimicrobial Surveillance Program. Vibativ is a patented, FDA approved anti-infective for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia. It is also approved for complicated skin and skin structure infections. It addresses a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant.

16:27 EDT Genfit Phase 3 trial of elafibranor in NASH fails to meet endpoint - Genfit announced results from an interim analysis of the RESOLVE-IT Phase 3 trial evaluating once-daily, 120mg of elafibranor in adults with non-alcoholic steatohepatitis. The trial did not meet the predefined primary endpoint of NASH resolution without worsening of fibrosis in the ITT population of 1,070 patients, the company said in a statement. The response rate in the 717 patients enrolled on study drug was 19.2% for patients who received elafibranor 120mg compared to 14.7% for patients in the placebo arm. On the fibrosis key secondary endpoint, 24.5% of patients who received elafibranor 120mg achieved fibrosis improvement of at least one stage compared to 22.4% in the placebo arm. The other key secondary endpoint related to metabolic parameters did not achieve statistical significance. No significant differences as compared to placebo were achieved on the key secondary endpoints, including fibrosis improvement of at least one stage and changes in metabolic parameters, said Genfit. Added Pascal Prigent, CEO, "These results are highly disappointing, not only for the GENFIT team, but also for patients and healthcare providers as there continues to be considerable unmet medical need in the NASH space. The GENFIT team is actively reviewing the full interim dataset and will be conducting additional analyses, to gain a clearer understanding of the higher than anticipated response rates in the placebo arm. We plan to share these detailed findings with the regulatory authorities in the coming months and with their guidance, determine a final decision regarding the continuation of the RESOLVE-IT trial. In parallel, we continue as planned with our NIS4TM and Phase 3 PBC (primary biliary cholangitis) programs, which are independent of our NASH program with elafibranor. We will provide updated guidance on our global corporate strategy later in the year."

16:19 EDT AcelRx says Tetraphase co-promotion pact to remain in place regardless of merger - AcelRx (ACRX) said it is aware of the May 8 disclosure by Tetraphase (TTPH) indicating it received a competing acquisition proposal from La Jolla Pharmaceutical (LJPC) that the Tetraphase board of directors believes constitutes or could reasonably be expected to lead to a superior offer. The Tetraphase Board also stated that it continued to recommend the AcelRx merger and has not made any recommendations with respect to the other competing acquisition proposal by La Jolla. "Our understanding is as follows: The La Jolla proposal is for an upfront value of $22M, payable in cash, inclusive of an estimate of approximately $11.9M in Black-Scholes consideration due to select warrant holders and approximately $10.1M for Tetraphase common equity holders (an implied price per share of $0.93), and contingent value rights of up to $12.5M. This compares to the AcelRx proposal for an upfront value of approximately $21.7M payable in stock, based on the closing price of AcelRx stock on May 8th, inclusive of an estimate of approximately $11.8M in Black-Scholes consideration due to select warrant holders and approximately $9.9M for Tetraphase common equity holders (an implied price per share of $0.92), and contingent value rights of up to $12.5M. Under the Merger Agreement with Tetraphase, should the Tetraphase Board indicate that it intends to change its recommendation in favor of the Merger Agreement, AcelRx would have the opportunity to respond within a specified time period. Regardless of whether the Tetraphase Board ultimately chooses to accept an offer - including the La Jolla offer - other than the AcelRx transaction under the Merger Agreement, the co-promotion agreement between the two companies would remain in place - safeguarded by significant financial obligations. If a party other than AcelRx ultimately combines with Tetraphase, they will promote DSUVIA and AcelRx will continue to promote XERAVA. AcelRx will provide additional updates to its stockholders regarding Tetraphase at the appropriate time," AcelRx said.

16:17 EDT Green Dot withdraws FY20 guidance - As the duration and severity of the COVID-19 pandemic is unknown, Green Dot is withdrawing its financial outlook for the full year 2020. Green Dot has already taken and will continue to implement incremental actions to reduce expenses to mitigate the financial impact of COVID-19 on the company. In response to the economic conditions arising from the pandemic, Green Dot has taken steps to strengthen its financial condition, including drawing down the full $100 million available under its revolving credit facility, instituting an enterprise-wide headcount freeze and delaying or reducing non-critical projects.

16:17 EDT Green Dot reports gross dollar volume $14.3B vs. $13.0B last year - Reports Q1 active accounts 5.74M vs. $6.05M last year.

16:11 EDT Neos Therapeutics announces 25% workforce reduction - Neos Therapeutics announced that it is reducing its cost structure by decreasing its workforce by approximately 25%. The reduction in force announced affects approximately 50 employees, or 25% of the company's workforce. Following these changes, the company will have approximately 45 sales territories, which represent approximately 80% of its current prescriber base for its Attention Deficit Hyperactivity Disorder business. The company plans to deploy alternative sales and marketing efforts toward many of the remaining 20% of current prescribers.

16:07 EDT Caesars notes agreement reached to sell Bally's Atlantic City - On April 24, Caesars Entertainment (CZR) announced an agreement to sell Bally's Atlantic City Hotel & Casino for approximately $25M in cash. VICI Properties (VICI) will receive approximately $19M from the sale, while Caesars will receive approximately $6M. The transaction is subject to regulatory approvals and other closing conditions.

16:06 EDT STAG Industrial promotes Michael Chase to Chief Investment Officer - STAG Industrial announced that Michael Chase, senior VP of Acquisitions, is being promoted to the additional role of Chief Investment Officer. This promotion is a part of a larger reorganization of our acquisition platform that will improve its market coverage and efficacy. The reorganized platform, that includes some territory realignment, will position STAG to better capture external growth opportunities going forward. Prior to his promotion, from 2011 to 2020, Chase served as senior VP of Acquisitions for the company.

16:02 EDT Veritiv obtains distribution rights for coated board from China from APP - Veritiv Corporation announced that its Canadian division, Veritiv Canada, will be the exclusive Canadian distributor of coated board from China from Asia Pulp & Paper, or APP. The relationship provides Veritiv exclusive marketing, selling, and distribution rights across Canada to APP's lineup of coated board from China.

15:52 EDT CEO of SoftBank-backed Banjo resigns amid reports of KKK ties - "Banjo, announced on May 8, that the company's current CEO and founder, Damien Patton had resigned and that the company will be transitioning to a new, reconstituted leadership team effectively immediately. Banjo's new CEO will be Justin R. Lindsey, the current CTO of the company...Banjo is a technology company based in the Salt Lake City area of Utah. It has developed products that seek to reduce human suffering and save lives by getting first responders the information they need to deploy public safety resources as quickly as possible. Through its company policies and patents, Banjo does this while maintaining an unswerving commitment to the protection of personal privacy information and data."...Banjo CEO, Damien Patton commented on Medium on April 28. "Today, Medium OneZero posted an article that focused on a dark and despicable period in my life that I am extremely remorseful about and sorry for. I am deeply ashamed of my actions and do not hold any of these beliefs, which I find abhorrent and indefensible." Reference Link

15:02 EDT Daniel Kretinsky's Vesa Equity takes 5% active stake in Macy's - Vesa Equity took a 5% active stake in Macy's. Vesa Equity disclosed in a regulatory filing that it took a 5% stake in Macy's according to a 13D filing. Vesa Equity said in the filing, that depending on market conditions, their continuing evaluation of the business and prospects of Macy's and other factors, Vesa Equity may dispose of or acquire additional shares of Macy's. Vesa Equity intends to engage in constructive discussions with the Issuer's management and/or board of directors, other stockholders of Macy's and other interested parties that may relate to the business, management, operations, including cost structure, assets, capitalization, financial condition, strategic plans, governance and board composition and the future of Macy's. The Fly notes that Vesa Equity is owned by Daniel Kretinsky, a Czech businessman and lawyer who is the CEO and 94% owner of Energetick a prmyslov holding, EPH, the largest energy group in Central Europe. The principal shareholder of Vesa Equity is EP Investment, which is ultimately beneficially owned by Daniel Ketinsky.

14:16 EDT GE Healthcare granted FCC waiver to expedite medical equipment - The Federal Communications Commission announced that it granted GE Healthcare's request for a waiver to allow the importation, marketing, and operation of certain GE medical devices from new suppliers for use in healthcare facilities. "The COVID-19 pandemic has caused an unprecedented strain on our nation's healthcare system. The action taken by the Commission today will enable GE Healthcare to overcome disruptions in the medical device supply chain as it addresses the surge in demand for critical medical equipment. Without the waiver, many of GE's devices that are sourced from new suppliers or that contain new components would have required prior FCC equipment certification, which would delay GE's ability to provide medical facilities with the equipment needed to treat patients," the FCC stated. Reference Link

14:01 EDT FTS International announces 1-for-20 reverse stock split - FTS International announced that the company's board of directors has approved a reverse stock split of the company's common stock, at a ratio of 1-for-20, following the approval of the reverse stock split by the company's stockholders at the Annual Meeting of Stockholders held on May 8. Beginning with the opening of trading on May 12, the company's common stock will trade on the New York Stock Exchange on a split-adjusted basis under a new CUSIP number, 30283W203. The company's trading symbol will continue to be "FTSI." The objective of the reverse stock split was to enable the company to regain compliance with the NYSE's minimum average share price requirement for continued listing on the NYSE and to meet the minimum share price requirement for a potential transfer of the company's listing to the NYSE American. The reverse stock split reduced the number of shares of common stock outstanding from approximately 107,110,919 to approximately 5,355,000, FTS stated.

13:32 EDT Cogent appoints Sean Wallace as CFO - Cogent Communications announced that Sean Wallace has been appointed VP, CFO and Treasurer of Cogent, effective immediately. Also on May 11, 2020, Thaddeus Weed, stepped down from his role of CFO, effective immediately. To facilitate an orderly transition, Weed will remain with Cogent as SVP, Audit & Operations. In addition, Jean-Michel Slagmuylder, who had been serving as Acting CFO and Treasurer of Cogent since March 17, 2020 during Weed's temporary medical leave of absence, stepped down from that role on May 11, 2020 and will return to his position of CFO for European Operations, effective immediately. Prior to joining Cogent, Mr. Wallace was an investor and operator of residential and industrial real estate projects from 2015.

13:15 EDT Delta Air Lines operating increasing number of daily Asia cargo-only flights - Starting May 13, Delta is increasing its cargo-only flights from Incheon to both Atlanta and Los Angeles to daily operations following increased demand to transport medical supplies and other goods from Asia to the United States. Last month, the airline flew to Atlanta four times weekly and to L.A. three times a week. Delta will also add another daily flight between Shanghai and Incheon, bringing the total to three. When combined with the existing daily Incheon-Detroit service, Delta now operates 124 weekly cargo-only flights, the company announced. Reference Link

13:09 EDT RMR Group 'well prepared' for what may be a long recovery

13:06 EDT Twitter rolls out new warning messages for misleading information on COVID-19 - Twiiter said in a blog post, "Starting today, we're introducing new labels and warning messages that will provide additional context and information on some Tweets containing disputed or misleading information related to COVID-19...During active conversations about disputed issues, it can be helpful to see additional context from trusted sources. Earlier this year, we introduced a new label for Tweets containing synthetic and manipulated media. Similar labels will now appear on Tweets containing potentially harmful, misleading information related to COVID-19. This will also apply to Tweets sent before today. These labels will link to a Twitter-curated page or external trusted source containing additional information on the claims made within the Tweet...Our teams are using and improving on internal systems to proactively monitor content related to COVID-19. These systems help ensure we're not amplifying Tweets with these warnings or labels and detecting the high-visibility content quickly. Additionally, we'll continue to rely on trusted partners to identify content that is likely to result in offline harm. Given the dynamic situation, we will prioritize review and labeling of content that could lead to increased exposure or transmission." Reference Link

11:29 EDT Choice Hotels sees COVID impact greater in Q2 relative to Q1 - Choice Hotels CFO Dominic Dragisich said on today's earnings call that the impact of COVID-19 is expected to be greater in Q2 relative to Q1.

11:19 EDT Cleveland-Cliffs says 'vast majority' of automotive production to resume - Cleveland-Cliffs CEO Lourenco Goncalves says "a vast majority of automotive production in this country to resume this week and next week."

10:52 EDT Cleveland-Cliffs has 'zero intention' of issuing additional debt or equities

10:00 EDT SunCoke Energy falls -10.5% - SunCoke Energy is down -10.5%, or -38c to $3.19.

10:00 EDT Scorpio Bulkers falls -15.5% - Scorpio Bulkers is down -15.5%, or -$3.10 to $16.96.

10:00 EDT Avaya rises 17.5% - Avaya is up 17.5%, or $1.83 to $12.30.

09:59 EDT Bassett Furniture announces 25% permanent reduction in workforce - Bassett Furniture said that due to "the level of disruption in the home furnishings industry, coupled with the uncertainty both of the pace at which the U.S. economy will recover and the level to which it will recover," Bassett announced a 25% permanent reduction in workforce, representing approximately 600 employees, throughout the retail, wholesale and logistics operations. 42% of the remaining workforce will remain on furlough through at least May 31, 2020 with the company paying for health care benefits. The company also announced the permanent closure of the Grand Prairie, Texas upholstery manufacturing operation with production shifted to the manufacturing location in Newton, North Carolina. "The company will continue to evaluate the pace of business to determine when to bring back the furloughed employees. No significant severance or restructuring charge is expected due to the above," Bassett stated. "While it is impossible to predict the rate at which sales will return to anywhere near 'normal' levels, we have seen incoming wholesale orders improve in each of the past four weeks," observed Spilman. "Meanwhile, we have taken the eight weeks of disruption to our routine to introspectively examine many facets of our business including the levels of the raw material inventory, total product line skus, architecture of our custom furniture programs, and user experience on our website. While we remain committed to our signature custom capabilities, we acknowledge that this form of selling becomes compromised when our fleet of brick and mortar retail stores is forced to close. Furthermore, we believe that the omnipresent migration to digital commerce accelerated during this highly unusual period of 'stay at home' behavior. We are therefore working to streamline our custom offerings and the manner in which they are presented on the web with the intention of generating more e-commerce and store sales alike. In this regard, we are striving to turn the unfortunate elements of today's announcement into the foundation of a leaner, more nimble, reinvented Bassett of the future," added Chairman and CEO Rob Spilman.

09:41 EDT Pyxis Tankers regains compliance with Nasdaq rule - Pyxis Tankers announced that it has regained compliance with the NASDAQ's continued listing requirements regarding the minimum closing bid price. On May 11, 2020, the Company received a written notification from NASDAQ stating that the closing bid price of the Company's common shares has been $1.00 per share or higher for the last ten consecutive trading days, from April 27, 2020 to May 8, 2020. Accordingly, the Company is again in compliance with the exchange's minimum closing bid price rule and the matter is closed.

09:39 EDT BioSpecifics appoints Joseph Truitt as permanent CEO - BioSpecifics announced the appointment of Joseph Truitt as CEO. Truitt was appointed interim CEO by the company's board on April 6 and assumed this permanent role on May 7.

09:38 EDT Ameresco partners with NH on energy savings performance contract - Ameresco announced that it is partnering with the State of New Hampshire on an energy savings performance contract that will allow for energy conservation measures at over twenty state facilities throughout New Hampshire's Seacoast Region. The facilities that will receive energy conservation measures include buildings managed by several state agencies including Fish and Game, Employment Security, Natural and Cultural Resources, Transportation and Administrative Services. By utilizing an Energy Savings Performance Contract, the State of New Hampshire will save energy without incurring any up-front costs. The State of New Hampshire will pay for the energy improvements utilizing the energy savings, estimated to be over $4M over the 20-year contract term. The project is expected to be completed in March 2021.

09:38 EDT Quest Diagnostics, Ortho Clinical Diagnostics expand COVID-19 antibody testing - Ortho Clinical Diagnostics announced it is working with Quest Diagnostics to expand COVID-19 antibody testing to more than 20 Quest laboratories across the U.S. Quest will use Ortho's Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test to test patients for detectable levels of SARS-CoV-2 antibodies, which are generated by the body in response to infection. Ortho's test, among only a small number in the world to be granted Emergency Use Authorization by the FDA, can be used as an aid in identifying patients with an immune response, indicating recent or prior infection, and may provide helpful information regarding decisions for getting people back to work. Individuals may have the virus for weeks after developing antibodies. The test offers 100% specificity, which helps prevent false positives.

09:37 EDT Kandi Technologies to delay 10-Q filing - Kandi Technologies announced that it would delay the filing of its 2020 Quarterly Report on Form 10-Q, which was originally due on May 11 as the impact in China of the current outbreak of COVID-19 "has presented significant challenges and undue hardship and expense for the company to file on a timely basis." The company has elected to rely on the SEC order and will endeavor to file the quarterly report no later than June 25, 2020, which is 45 days after the original due date. "The company also reiterated its caution regarding potential impacts from the ongoing virus crisis. The current outbreak of COVID-19 has had a significant impact on the global economy and many industries, including the automobile and parts industry. Affected by COVID-19, we expect the first quarter of 2020 will see large revenue decrease on EV parts sales comparing to the corresponding quarter in 2019. We are actively monitoring the recent coronavirus outbreak and its potential impact on our supply chain and operations. Due to current and potential future port closures and other restrictions resulting from the outbreak, global supply may become constrained, which may cause the negative impact on our sale of off-road vehicles to the U.S. While we do not expect that the virus will have a material adverse effect on our business or financial results at this time, we are unable to accurately predict the impact that COVID-19 will have due to various uncertainties, including the ultimate geographic spread of the virus, the severity of the disease, the duration of the outbreak, and effectiveness of the actions that may be taken by governmental authorities. The management has been closely monitoring the impact caused by COVID-19 and we will continue to operate our business as steadily and safely as we can," Kandi added.

09:35 EDT Teekay LNG, Teekay announce elimination of incentive distribution rights - Teekay Corporation (TK) and Teekay LNG Partners L.P. (TGP) announced the execution of a definitive agreement to eliminate all of the Partnership's incentive distribution rights in exchange for 10.75 million newly-issued Teekay LNG common units. The Transaction concurrently closed on May 11, 2020. Following the completion of this Transaction, Teekay now beneficially owns approximately 36 million Teekay LNG common units and remains the sole owner of Teekay GP L.L.C., the general partner of Teekay LNG, which together represents an economic interest of approximately 42 percent in the Partnership. The Boards of Directors of Teekay and Teekay GP, as well as the Teekay GP Conflicts Committee, which consists entirely of independent directors, unanimously approved the IDR elimination transaction.

09:34 EDT Enthusiast Gaming forms content creation partnership with ZHU - Enthusiast Gaming announced it has entered into a content creation partnership with GRAMMY-nominated artist ZHU. To celebrate the partnership, Enthusiast Gaming and its esports division, Luminosity Gaming are launching a global live concert featuring ZHU and Luminosity streamer and incognito DJ, Harley Fresh, aka "MrFreshAsian". On May 14, 2020, the concert will be live streamed on the front page of Twitch.TV and will also be the platform to promote ZHU's new single, "ONLY" which will drop right after the live concert. Pre-save "ONLY" here. The event will be featured across the Enthusiast Gaming platform with additional support from event partners Twitch and GFUEL. Donations from the concert will be in support of MusiCares COVID -19 Relief Fund. Steven Zhu is one of the most recognized DJ's in the world. ZHU built his career off of grassroots support and guerilla marketing leading to nearly a half-billion online plays on Spotify alone. His album "Generationwhy" reached platinum status and No. 1 on Billboard's Dance/Electronic album charts. Like ZHU, MrFreshAsian is globally recognized as one of the best Fortnite streamers in the world. The Luminosity team member was recently named Twitch Streamer of the Year by the Shorty Awards. Fresh is one of Luminosity's key esports influencers and produces exclusive content for over eight million loyal fans across his social channels. During the three-hour charity stream which starts at 9pm EDT, members from Luminosity's Fortnite House will host a pre-concert show which will lead into Fresh and ZHU each performing individual DJ sets, lasting until midnight EDT. The evening concludes with the 12am EDT world premiere and release of ZHU's new single, "ONLY" ft. Tinashe. Fans will be able to interact with the artists during a live Q&A as well as donate throughout the stream or purchase exclusive merchandise with all proceeds benefiting MusiCares COVID-19 Relief Fund.

09:32 EDT Huitao Technology to acquire Color China in stock, cash transaction - Color Star Technology, formerly known as Huitao Technology, announced that on it entered into a share exchange agreement with Color China and all the shareholders of Color China to purchase all of the outstanding issued shares of Color China. Upon completion of the acquisition, Color Star will own 100% of Color China. Color Star will issue to the shareholders of Color China 4.6M ordinary shares of the company and pay an aggregate of $2M in immediately available cash upon closing. Closing of the acquisition is subject to the fulfillment or waiver of all closing conditions.

09:30 EDT Coty trading halted, volatility trading pause

09:30 EDT Jazz Pharmaceuticals, Bionical Emas agree to provide lurbinectedin via EAP - Bionical Emas and Jazz Pharmaceuticals have entered into an agreement to provide appropriate patients in the United States who have relapsed Small Cell Lung Cancer, or SCLC, lurbinectedin via an Expanded Access Program, or EAP. Lurbinectedin is an investigational drug under review by the FDA. The EAP is open to patients who are unable to enter clinical trials and for whom there are no appropriate alternative treatments while lurbinectedin is under regulatory review by the FDA. The EAP was originally launched in January between Bionical Emas and PharmaMar S.A. and now has successfully transitioned from PharmaMar to Jazz.

09:28 EDT Vera Bradley expects to open stores in phased approach - Vera Bradley announced additional business updates related to COVID-19. The Company expects to open additional stores in a phased approach, with over half of its 149 Full Line and Factory stores planned to be open by the end of May and nearly the entire store base planned to be open by the end of June. As Vera Bradley stores reopen, the Company is implementing several procedures and precautions to keep customers and Associates safe and secure, including: Health and safety training on new policies and procedures for all Associates before store reopening, Providing face coverings and gloves for Associates and requesting that customers wear face coverings when shopping in stores, Social distancing of six feet or more, including prominent signage, limiting the number of customers in each store, and line control during checkout, Increasing cleaning and sanitization, Ready access to hand sanitizer for Associates and customers, Installation of plexiglass dividers at checkout stations, Offering curbside pick-up services at select stores, Reducing hours of operation, Measures to ensure compliance with all state and local requirements, Information as to the status of the Company's stores, including up-to-date store openings and store hours, can be found on verabradley.com, under the "Find a Store" heading. As announced in earlier press releases, the Company took several actions to protect its financial position, maximize liquidity, and to position the Company for a strong "reopening" once the pandemic subsides. Those actions included: Temporarily furloughing approximately 80% of its workforce. Temporarily reducing base compensation for remaining Associates, with reductions on a graduated scale ranging from 15% to 30%, and 75% for the Chief Executive Officer. Temporarily suspending cash compensation to the board of directors. Temporarily suspending its share buyback program. Accessing $60 million from its previously unused bank line of credit. Temporarily eliminating the Company 401(k) and charitable donation matches. Tightly managing inventory levels through the cancellation of orders, delay of receipts, or seeking price concessions where possible. Actively working with landlords on addressing rent abatement and payment terms as well as delaying or cancelling certain planned new store openings. Reducing non-payroll operating expenses, including but not limited to, marketing and travel. Extending vendor payment terms In addition, the Company is taking advantage of elements of the Coronavirus Aid Relief and Economic Security Act, as appropriate.

09:25 EDT INmune Bio's says INB03 inhibits cell migration, tumor growth - INmune Bio announced presentation of a study demonstrating the combination of INB03 with lapatinib reverses resistance to therapy in trastuzumab resistant HER2+ breast cancer. The work lays the groundwork for INmune Bio's planned Phase II trial and, was chosen for an oral presentation at the New York Academy of Science Frontiers in Cancer Immunotherapy 2020 publication on Monday, 11 May. Sophi Bruni, a doctoral student in the laboratory of Dr. Roxana Schillaci, in the Lab of Molecular Mechanisms, Instituto de Biologia y Medicina Experimental-CONICET, Argentina will be presenting the work. This presentation is part of the evolving body of work by Dr. Schillaci and her team in the role of soluble TNF in resistance to immunotherapies in cancer. Dr. Schillaci previously reported that women with MUC4 expressing HER2+ breast cancers are resistant to trastuzumab and downregulation of MUC4 with INB03 reversed trastuzumab resistance. This work is part of a larger body of work looking at reversal of resistance to tyrosine kinase inhibitors in HER2+ breast cancer.

09:21 EDT Orbit International reports April bookings for Electronics in excess of $1.85M - Orbit International announced that its Electronics Group's bookings for the month of April 2020 exceeded $1,850,000. Bookings for the month of April 2020 were highlighted by a follow-on order of approximately $970,000 for keyboards used on a major military aviation program and a follow-on order received by our Q-Vio subsidiary for approximately $560,000 for a program for the U.S. Army. Other orders received during the quarter for the OEG consisted primarily of displays, control panels and repairs. Deliveries for contracts received during April have already commenced and are expected to continue through the second quarter of 2022.

09:19 EDT One Stop Systems receives over $3.5M in production orders - One Stop Systems has received more than $3.5 million in production orders for its new Gen 4 PCIe products from multiple OEM customers for delivery in 2020. As the first company to introduce Gen 4-based components to the market, the orders demonstrate OSS' continued leadership in high-performance edge computing.

09:16 EDT BioDelivery Sciences appoints Jeff Bailey as interim CEO - BioDelivery Sciences announced that Jeffrey A. Bailey, a member of the Company's Board of Directors, has been named Interim Chief Executive Officer, effective today. Mr. Bailey succeeds Herm Cukier as CEO. Mr. Bailey has served as Chairman of Aileron Therapeutics since March 2018 and as a Board Member of Madison Vaccines, a privately held biopharmaceutical company, since October 2017.

09:14 EDT Ascendis Pharma to appoint Jesper Hoiland as global CCO - Ascendis Pharma (ASND) announced that the company will appoint Jesper Hoiland as Global Chief Commercial Officer upon completion of his transition from Radius Health (RDUS). Mr. Hoiland most recently served as President and Chief Executive Officer of Radius Health until May 2020.

09:12 EDT Bellerophon announces FDA clearance for initiation of Phase 3 study for INOpulse - Bellerophon Therapeutics announced that the U.S. Food and Drug Administration accepted its Investigational New Drug application, allowing the Company to initiate a Phase 3 study of INOpulse inhaled nitric oxide therapy in up to 500 patients infected with COVID-19. The IND acceptance follows agreement by the FDA earlier this year to allow investigational treatment with INOpulse for COVID-19 patients under emergency expanded access. To date, over 50 patients with COVID-19 have received treatment with INOpulse under the care and supervision of their physicians. The Phase 3 randomized, placebo-controlled study, called PULSE-CVD19-001, will evaluate the efficacy and safety of INOpulse in patients diagnosed with COVID-19 who require supplemental oxygen before the disease progresses to necessitate mechanical ventilation support. The PULSE-CVD19-001 protocol utilizes an adaptive design and aims to enroll up to 500 patients with COVID-19 who will be treated with either INOpulse or placebo. The primary endpoint will assess the proportion of subjects that had respiratory failure or mortality, which should allow the trial to serve as a registrational study for approval. In parallel, the Company has applied for federal funding, through the Biomedical Advanced Research and Development Authority and the National Institutes of Health, to support the clinical study. COVID-19 is caused by the SARS-CoV-2 coronavirus, which is approximately 82% identical to the severe acute respiratory syndrome related coronavirus that caused a global outbreak between 2003 and 2004. Prior studies have shown that nitric oxide could provide benefit in treating SARS-CoV by preventing viral replication, improving arterial oxygenation, reducing the need for ventilation support and preventing the proliferation of pneumonia lung infiltrates. Based on the genetic similarities between the two coronaviruses, the historical data in SARS-CoV support the potential for iNO to provide meaningful benefit for patients infected with COVID-19. Nitric oxide is a naturally produced molecule that is a powerful vasodilator improving arterial oxygenation and as part of the immune response to pathogens plays a key role in preventing viral replication. The proprietary INOpulse delivery system from Bellerophon Therapeutics is an investigational system that is portable and designed to deliver nitric oxide in a targeted, pulsatile manner that ensures accurate drug delivery and allows for use in outpatient settings outside of the hospital.

09:10 EDT Genasys donates PSS module to The Salvation Army Western Territory - Genasys announced that it has donated its Personal Safety Service software module to The Salvation Army U.S.A. Western Territory. The Company is helping the Western Territory implement the Company's PSS to help unify the Salvation Army's response to COVID-19 and other disasters.

09:09 EDT PepsiCo announces new direct-to-consumer offerings - As consumers increasingly turn online for their food and beverage needs during the COVID-19 pandemic, PepsiCo announced the launch of PantryShop.com and Snacks.com, two direct-to-consumer websites where shoppers can order an assortment of PepsiCo's trusted and loved food and beverage brands. On PantryShop.com, consumers can order specialized bundles containing PepsiCo's top-selling, pantry favorites from brands like Quaker, Gatorade, SunChips and Tropicana, within categories such as "Rise & Shine," "Snacking," and "Workout & Recovery." These pantry kits have been thoughtfully curated based on affinity research and are designed to meet consumers' 'new normal' such as working and exercising from home and homeschooling. They are easily accessible through a seamless, mobile-optimized ordering experience: with just a couple of clicks, shoppers can check out with free standard shipping. The multi-product pantry kits are priced at $29.95 and $49.95. On Snacks.com, consumers can choose from more than 100 of their favorite Frito-Lay products from a variety of iconic brands like Lay's, Tostitos, Cheetos and Ruffles, as well as dips, crackers, nuts and more. New items will continue to be added in the coming months as the site is customized to meet consumer preferences. As an introductory offer, shoppers will receive free shipping with a purchase of $15 or more. "PantryShop.com and Snacks.com were developed from concept to execution in less than 30 days by leveraging a combination of PepsiCo's technology, insights, resources and inventory to quickly meet consumers' evolving needs. In addition to buying for themselves, consumers can ship products as gifts to friends and family via both platforms and the majority of orders on PantryShop.com and Snacks.com will arrive within two business days."

09:07 EDT Cocrystal reprioritizes development activities to accelerate COVID-19 program - Cocrystal Pharma provided an update on the impact of the COVID-19 global pandemic on its preclinical and clinical development programs. "We have reprioritized development activities to accelerate the advancement of our preclinical COVID-19 program, which we recently established as a result of our license agreements with Kansas State University Research Foundation," commented Dr. Gary Wilcox, Chairman and Chief Executive Officer of Cocrystal. "Like many of our peers, we have been working to minimize the impact of the COVID-19 pandemic on our operations. While we have been able to mitigate some of the risks, the worldwide impact on supply chains has resulted in a delay to our fully owned influenza A virus program. The full impact of COVID-19 on our development programs remains uncertain, but our team is determined to advance preclinical and clinical development programs across our pipeline as quickly and efficiently as possible." Influenza A/B Inhibitors: Merck Collaboration: Cocrystal's exclusive license and collaboration agreement with Merck (MRK) to discover and develop certain proprietary influenza A/B antiviral agents remains ongoing. Cocrystal has been working with the scientific leadership at Merck over the past year in advancing the joint influenza A/B program. Merck, a global healthcare company with a history of over 125-years of drug discovery and innovation, has funded the collaborative influenza A/B program and could provide up to $156 million in milestones payments as the collaboration proceeds through clinical and commercial development. The research and collaboration agreement with Merck also provides for royalties following commercialization. CC-42344: Influenza A Program: The Company's lead molecule in development, CC-42344, is currently being evaluated in preclinical IND-enabling studies for the treatment of influenza. CC-42344 has shown excellent antiviral activity against influenza A strains, including avian pandemic strains and Tamiflu resistant strains, and shows a favorable pharmacokinetic and safety profile. Cocrystal is currently working to secure its supply chain and initiate its second lot of API synthesis for its influenza A program in Q3 2020. Subject to any additional delays due to the evolving COVID-19 pandemic, Cocrystal expects to file its regulatory submission and commence its Phase 1a study in 2021. COVID-19 Coronavirus Program: The Company is currently advancing its Coronavirus program by leveraging the rights to preclinical leads from its license agreements with KSURF to further develop certain proprietary broad-spectrum antiviral compounds for the treatment of coronavirus infections. The additional compounds licensed from KSURF have demonstrated both in vitro and in vivo activity in animal models against the viral pathogens causing MERS and SARS, coronaviruses that are structurally similar to SARS-CoV-2, which is responsible for the COVID-19 pandemic. Cocrystal initiated its preclinical studies of COVID-19 inhibitors received from KSURF during Q2 2020, and further intends to identify additional COVID-19 inhibitors utilizing its proprietary platform technology over the course of the second and third quarter of this year. The Company plans to identify additional inhibitors using its proprietary platform technology in Q3 2020 and anticipates the selection of its lead preclinical molecule in Q4 2020. CC-31244: Hepatitis C Program: The final study report of Cocrystal's U.S. Phase 2a clinical trial evaluating CC-31244 combination therapy for the ultrashort treatment of hepatitis C virus infected individuals has been completed and confirms the previously released data that it is effective and well tolerated. Partnering efforts are currently underway for the Company's fully owned ultrashort treatment of HCV. Norovirus Program: Cocrystal continues to identify and develop non-nucleoside polymerase inhibitors using its proprietary structure-based drug design technology platform. Cocrystal recently entered into a license agreement with KSURF to further develop certain proprietary broad-spectrum antiviral compounds for humans to treat Norovirus and Coronavirus infections. Preclinical activities for Cocrystal's Norovirus program are currently underway. The Company expects to complete its proof-of-concept animal model study in Q4 2020.

09:01 EDT Potbelly appoints David Near, Todd Smith to board of directors - Potbelly Corporation announced that it has reached an agreement with shareholders led by Vann A. Avedisian to appoint David J. Near and Todd W. Smith to the Company's Board of Directors, effective immediately. With the appointments of Messrs. Near and Smith, the Board will be comprised of 10 directors, 9 of whom are independent. Pursuant to the Agreement, the Board also agreed to include David J. Near and Todd W. Smith in Potbelly's slate of nominees for election to the Board at the 2020 Annual Meeting. The Shareholder Investors agreed to vote in favor of all of the Company's nominees at the 2020 Annual Meeting and have withdrawn their nomination notice. The Agreement will be included as an exhibit to the Company's current report on Form 8-K which will be filed with the Securities and Exchange Commission.

08:57 EDT Gold Resource expands Nevada 'Scarlet' target - Gold Resource Corporation announced multiple ore grade intercepts from its phase two drill program at the "Scarlet" target located 400 meters northwest of its operating Isabella Pearl mine in Mineral County, Nevada. Near surface ore grade gold intercepts included 12.19 meters grading 1.43 grams per tonne gold, including 3.05 meters grading 4.02 g/t gold, expanding on phase one drill results reported earlier in January 2020 which included 24.38 meters grading 1.03 g/t gold. Gold Resource Corporation is a gold and silver producer, developer and explorer with operations in Oaxaca, Mexico and Nevada, USA. The Company has returned $114 million to its shareholders in consecutive monthly dividends since July 2010 and offers its shareholders the option to convert their cash dividends into physical gold and silver and take delivery. The Company previously collected numerous high-grade gold surface samples at Scarlet, mapped several structural trends coincident with existing structures in the Isabella Pearl Mine's open pit, and reported on a successful phase one drill program in January 2020. Scarlet is the first of many mineralized targets to the northwest of the Company's operating mine. Gold Resource Corporation's Isabella Pearl property controls 10-kilometers of mineralized trend in this area along the Walker Lane Mineral Belt. This phase two drill program focused primarily on the southeast portion of the Scarlet target, with all drill holes, as the first phase, positioned within the current permitted Isabella Pearl mine plan development area. These phase two Scarlet drill results confirm that gold grades and mineralization thickness is increasing in this northwest area. Having been granted the Notice of Intent from the BLM to drill the northwest Scarlet target outside of the current mine plan boundary, a phase three drill program is scheduled to begin in the coming weeks.

08:55 EDT Catalyst Biosciences announces expected milestones - MarzAA: Report final data in the second quarter of 2020 from a MarzAA Phase 1 pharmacokinetic and pharmacodynamic study to support future SQ treatment of bleed studies. Initiate a Phase 3 open-label trial in 2020, evaluating the efficacy of SQ MarzAA to treat episodic bleeding in individuals with hemophilia A or B with inhibitors, subject to the readiness of trial sites and improvements in the current effects of COVID-19 on clinical trial execution. DalcAA: Report final Phase 2b trial data in the second quarter of 2020. CB 2679d-GT: Report initial non-human primate data in the second quarter of 2020.

08:52 EDT Onconova to hold Annual Meeting virtually - Onconova Therapeutics announced that, as disclosed in the Company's Definitive Proxy Statement for the Company's 2020 Annual Meeting of Stockholders, due to the public health impact of the COVID-19 pandemic, the Company's Annual Meeting of Stockholders will be held in a virtual meeting webcast format, beginning at 10:30 a.m. EDT on Wednesday, May 27, 2020. Stockholders will not be able to attend the Annual Meeting in person.

08:50 EDT Galectin Therapeutics expects first initiation in NASH-RX trial in 2Q20 - The NASH-RX trial will use an adaptive design, confirm dose selection, and reaffirm the efficacy data observed in the NASH-CX trial and, with pre-planned adaptations, inform the larger Phase 3 trial component. The protocol for a seamless adaptively-designed Phase 2b/3 clinical study, the NASH-RX trial, was submitted to the U.S. Food and Drug Administration on April 30, 2020. The filing currently anticipates clinical trials will begin in the second quarter of this year. The design of this trial reflects the unmet medical needs of the target patient population for belapectin treatment: NASH patients with compensated cirrhosis who develop esophageal varices. Bleeding varices are a cause of death in about one-third of cirrhotic patients. Currently, there is no approved treatment for preventing varices in these patients. The development of new varices reflects the progression of hepatic cirrhosis and thus portends the development of other cirrhosis complications and outcomes such as significant ascites, hepatic encephalopathy, and eventual liver failure. In addition on March 31, 2020, the Company also filed with the FDA a protocol for the hepatic impairment study, with the study also currently anticipated to begin in the second quarter of this year. Galectin Therapeutics will share more details about the protocol at the time the clinical trial begins.

08:45 EDT Dare Bioscience, Health Decisions form strategic partnership for novel pipeline - Dare Bioscience announced that the companies have signed a partnership agreement under which Health Decisions will exclusively provide CRO services within the United States to support the clinical development of Dare's innovative pipeline of novel programs designed specifically to address persistent unmet needs in the areas of contraception, fertility, and broader gynecological disorders. Dare and Health Decisions have successfully worked together on prior Dare clinical studies, including the post-coital test clinical study of Ovaprene. The partnership agreement provides for dedicated resources and new pricing structures, which, together with Health Decisions' expertise, site network and relationships with key opinion leaders and investigators, are expected to accelerate clinical development of key programs in a capital-efficient manner. Under the terms of the agreement, Health Decisions will be Dare's exclusive provider of CRO services within the United States for all of Dare's reproductive health assets for an initial three-year period, provided that Health Decisions has the expertise, resources and availability to perform the clinical research services that Dare requires. This includes the assets that Dare has or may have in development for pregnancy and delivery, contraception, infertility, polycystic ovarian syndrome and endometriosis during that period. In exchange for CRO exclusivity, Health Decisions will provide a core team of personnel dedicated to supporting all of Dare's development programs covered by the agreement, including Dare's pivotal clinical study of Ovaprene(R), a hormone-free, monthly contraceptive whose U.S. commercial rights are under a license agreement with Bayer, and the planned DARE-BV1 Phase 3 study in bacterial vaginosis, with topline data expected in 2020.

08:45 EDT Marriott to sell gift cards for future stays at 20% off, says CEO Sorenson

08:41 EDT ContraFect announces four abstracts published in 30th ECCMID abstract book - ContraFect announced the publication of four abstracts in the 30th European Congress of Clinical Microbiology and Infectious Diseases abstract book. Exebacase: A native lysin targeting Staphylococcus aureus, including MRSA, in Phase 3 clinical development: Exebacase is currently being studied in the Phase 3 DISRUPT superiority design study of exebacase in patients with Staph aureus bacteremia, including right-sided endocarditis. Enrollment into the Phase 3 DISRUPT study is ongoing, with patients being randomized, and clinical trial sites open and active. Exebacase was the subject of the following two abstracts published in the ECCMID Abstract Book. Abstract Title: Therapeutic innovation in bone and joint infections: evaluation of the activity of exebacase on clinical strains belonging to Staphylococcus epidermidis species: ContraFect provided early access to exebacase to individual named patients with chronic post-operative prosthetic joint infections under Temporary Authorizations for Use from the French National Agency for Medicines and Health Products Safety in collaboration with Dr. Tristan Ferry at the Hopital de la Croix Rousse in Lyon, France. The abstract describes the results of four patients who were treated with exebacase, administered intra-articularly. All had chronic, relapsing prosthetic joint infections, with several previous prosthetic knee revisions and other procedures. Two had clinical signs of septic arthritis and the two others had fistula. No adverse events occurred during arthroscopy. After 1 year follow up, the outcome was favorable in the two septic arthritis patients, with disappearance of clinical signs of septic arthritis. The Company believes this is an early indication that exebacase has the potential to be used in patients with relapsing prosthetic joint Staph aureus infections. Abstract Title: Exebacase resensitizes methicillin-resistant Staphylococcus aureus to oxacillin in a rabbit model of infective endocarditis: In this rigorous rabbit model of endovascular MRSA infection, multiple dose regimens of exebacase administered in addition to oxacillin significantly reduced MRSA counts by 5 log10 cfu/g tissue compared to oxacillin treatment alone, exebacase alone, and growth controls. This marked reduction in target tissue MRSA CFUs is consistent with resensitization of MRSA to oxacillin. The potential ability of exebacase to resensitize MRSA to oxacillin could have important therapeutic implications with the potential for exebacase to "reverse" antimicrobial resistance. CF-370: An engineered lysin targeting Pseudomonas aeruginosa, including extensively resistant strains: ContraFect announced its next product candidate, CF-370, in December 2019. CF-370 was selected for further development based on its potent in vitro bactericidal and antibiofilm activity and in vivo activity and tolerability in preclinical animal models. In addition, the Company found CF-370 to have favorable properties for manufacturing and potentially favorable intellectual property rights as a proprietary engineered lysin. The potent in vivo activity in preclinical models is the subject of the abstract discussed below. Abstract Title: First evidence of systemic efficacy of a pathogen-targeted, engineered lysin against carbapenem-resistant Pseudomonas aeruginosa, in a rabbit pneumonia model: The in vivo activity of CF-370 against P. aeruginosa was studied in a rabbit pneumonia model. CF-370 was well-tolerated and conferred a survival advantage to animals with 100% survival compared to only 40% survival among vehicle control animals. In animals receiving either meropenem or CF-370 alone, the mean bacterial lung counts decreased by 1.5-2log10 CFU/g versus pretreatment or vehicle-treated controls CF-370 in addition to meropenem was synergistic, with bacterial counts in all target tissues decreasing by an additional 2log10 CFU/g versus meropenem or CF-370 alone. This study provides in vivo proof-of-concept for CF-370 as a potential treatment for P. aeruginosa lung infections and for lysins as a new modality to combat the threat of multidrug-resistant Gram-negative pathogens. Amurin Peptides: Another new modality with broad spectrum activity against antibiotic-resistant Gram-negative pathogens: Amurin peptides have demonstrated potent in vitro activity against a wide range of resistant Gram-negative pathogens, including carbapenem-resistant Enterobacteriaceae and Acinetobacter baumannii, both designated as urgent threats by the U.S. Centers for Disease Control. Amurin peptides exhibit the hallmark properties of DLAs, including rapid antibacterial activity, synergy with conventional antibiotics, eradication of biofilms and no detectable spontaneous resistance. Abstract Title: First report of the discovery of amurin peptides: direct lytic agents with broad activity against carbapenem-resistant Enterobacteriaciae, Acinetobacter, and Pseudomonas, including colistin-resistant strains: The table summarizes the highly potent in vitro activity of three promising amurin peptide candidates observed against clinical infection isolates from the CDC & FDA Antibiotic Resistant Isolate Panels comprised of 177 strains including Enterobacteriaceae, A. baumannii, and P. aeruginosa, including carbapenem-resistant and extensively-resistant strains, that are resistant even to antibiotics of last resort.

08:38 EDT Mylan says on track to close pending Upjohn combination in second half - Mylan CEO Heather Bresch said, "As we navigate the COVID-19 environment, our hearts and thoughts are with those who have been affected by COVID-19, and all of the healthcare workers and first responders who continue to go above and beyond to help save lives across the globe. I also would like to extend a special message of gratitude to our own Mylan family around the world. Thanks to their commitment, we have been able to continue meeting patient needs, even amid the challenges of a global pandemic. These efforts are reflected in our first quarter results, which came in with total revenues growing 5%, or 8% on a constant currency basis. We're also reaffirming revenue guidance to be in the range of $11.5B and $12.5B, absorbing approximately $200M of foreign exchange headwinds versus our previous expectations, and adjusted EBITDA to be in the range of $3.2B to $3.9B, absorbing approximately $50M of foreign exchange headwinds versus our previous expectations. These ranges account for COVID-19 impacts forecasted through the second quarter. Looking ahead, we remain on track to close the pending combination with Pfizer's Upjohn Business in the second half of the year and continue to have great confidence that Viatris will be well positioned to deliver value for all of our stakeholders as a true partner of choice."

08:35 EDT Marriott: Negative trends appear to have bottomed in most regions

08:33 EDT Marriott: COVID-19 by far the most significant crisis ever to impact business - Comments taken from Q1 earnings conference call.

08:30 EDT Quanterix announces Simoa platform used in development of COVID-19 antibody test - Quanterix announced that researchers have developed a sensitive and specific serology test using the company's ultra-sensitive Simoa platform for the detection and measurement of anti-SARS-CoV-2 IgG, IgM, and IgA antibodies against four immunogenic viral proteins. Results from a recently released preprint of the study, which provide detailed information about early stages of immune response in COVID-19 positive patients, demonstrate that Simoa assays can detect seroconversion as soon as one day after symptom onset using less than a microliter of plasma. Led by David Walt, Ph.D., who is a scientific founder and Board member of Quanterix, as well as the Hansjorg Wyss Professor of Biologically Inspired Engineering at Harvard Medical School and a Professor of Pathology at Brigham and Women's Hospital, the scientific breakthrough can aid epidemiologists in determining a more accurate population prevalence of COVID-19. The manuscript, "Ultra-Sensitive High-Resolution Profiling of Anti-SARS-CoV-2 Antibodies for Detecting Early Seroconversion in COVID-19 Patients," is posted on the medRxiv preprint server and is currently pending peer review. The multiplex serological assay, which was licensed by Brigham and Women's Hospital to Quanterix, has demonstrated the ability to detect antibodies against SARS-CoV-2 and identify individuals who have been infected with the virus but were asymptomatic or had mild symptoms, thereby providing a better understanding of how widespread the virus is within a population. The Simoa assay has the potential to become a new standard by which researchers can conduct COVID-19 serological profiling and will be a valuable tool for answering important questions about the heterogeneity of clinical presentation seen in the ongoing pandemic. As such, Quanterix plans to explore the potential of transitioning the assay from its current laboratory research phase of development to a commercially available product given its critical importance to population health.

08:28 EDT Heat Biologics reports continued progres advancing HS-110 - Heat Biologics provided an update on its Phase 2 trial of its T-cell activating HS-110, in combination with Opdivo in advanced non-small cell lung cancer, or NSCLC. Recent highlights: American Society of Clinical Oncology poster presentation on "Tumor antigen expression and survival of patients with previously treated advanced non-small cell lung cancer, or NSCLC, receiving viagenpumatucel-L, or HS-110, plus nivolumab" on May 29th presenting latest survival data of HS-110 in combination with nivolumab in previously treated, immunotherapy naive patients with advanced non-small cell lung cancer; Established partnership for biomarker development with Earle A. Chiles Research Institute of the Providence Cancer Institute in Portland, Oregon; Plan to initiate Type B end of Phase 2 meeting with the FDA to discuss registration strategy. Jeff Wolf, CEO of Heat, commented, "We continue to make good progress on our clinical-stage portfolio, as well as our COVID-19 vaccine platform, and look forward to presenting additional HS-110 data on May 29 at ASCO. Additionally, we are excited to proceed with our partnership for biomarker development with the Providence Cancer Institute to find a tissue-based marker that will help predict patient treatment response with HS-110 and nivolumab. Finally, we are in the process of preparing a data package for an End of Phase 2 Meeting with the FDA. This meeting will represent an important milestone in finalizing our registrational strategy for HS-110. We are highly encouraged by the data thus far and look forward to providing the latest study results at ASCO."

08:19 EDT Histogen receives IND approval to initiate Phase 1b/2a trial of HST 001 - Histogen announced that the U.S. Food and Drug Administration has approved its Investigational New Drug application for HST 001, the Company's lead therapeutic candidate for the treatment of androgenic alopecia in men. Under this IND, Histogen intends to initiate a Phase 1b/2a clinical trial of HST 001, a Hair Stimulating Complex, in the second quarter of 2020. This clinical trial is designed to assess the safety, tolerability and efficacy of HST 001, as well as determine optimal dosing in male pattern hair loss. Start-up activities are currently underway to include clinical study site preparation and subject screening. Histogen's product candidates are derived from a single, proprietary manufacturing process that yields materials that replace tissues in the body or stimulate the body's own cells to regenerate. In addition to clinical development of HST 001, Histogen anticipates IDE approval to initiate a Phase 1 clinical trial of a novel dermal filler in the coming months, and IND submission of its joint cartilage regeneration product candidate later this year. On January 28, 2020, Histogen announced that it entered into a definitive agreement with Conatus Pharmaceuticals pursuant to which Histogen will merge with and into a wholly-owned subsidiary of Conatus in an all-stock transaction. The combined company is expected to operate under the name "Histogen Inc.", and after closing, the combined company is expected to change its trading symbol to "HSTO" and trade on the Nasdaq Capital Market, and to focus on advancement of its patented technology for dermatological and orthopedic indications.

08:12 EDT Aruba enters collaboration with Microsoft - Aruba, a Hewlett Packard Enterprise company (HPE) announced the integration of Aruba ClearPass Policy Manager with Microsoft (MSFT) endpoint protection platforms to deliver significant advances in enterprise cyberattack protection. This integration allows ClearPass to control access to critical network resources based on endpoint security intelligence provided by Microsoft, reducing the risk posed by compromised network connections. Aruba has also collaborated with Microsoft to improve the efficiency and security of access control communications by developing a standardized approach to support multiple authentication methods and identity types in a single authentication request. The solution uses the Tunneled EAP protocol to combine both machine and user identities in a single request.

08:10 EDT Cleveland-Cliffs sees 'fairly strong' operations in second half - Regarding business outlook, CEO Lourenco Goncalve stated, "Our 2020 Adjusted EBITDA performance and capital needs will be dependent upon the strength and speed of the recovery of our important end-markets through the balance of the year, most notably the automotive industry. Although the pandemic effect led to automotive plant shutdowns over the past six weeks, the timing and pace of production restarts as well as consumer sales data have both exceeded our expectations. If the automotive manufacturers continue to restart production as they have indicated to us and already started to do, our operations will normalize throughout the balance of the second quarter, with a fairly strong second half of the year. With our liquidity in great shape and stay-at-home restrictions easing, we are planning to restart HBI construction as soon as possible. The pandemic and associated manufacturing stoppages have created a severe scarcity of scrap in the marketplace that further increases demand and magnifies the value of our HBI. Our decisive actions and low fixed cost position have enabled us to navigate through the worst parts of the crisis successfully, and we are well positioned to meet our customer demand now that business conditions have begun to improve."

08:08 EDT Rubius Therapeutics on track to file IND application for RTX-321 by year-end

08:08 EDT Rubius Therapeutics sees cash runway into 2022 - As of March 31, 2020, cash, cash equivalents and investments were $241.4 million, compared to $283.3 million as of December 31, 2019, providing Rubius with a cash runway into 2022. During the quarter, the Company used $40.0 million of cash to fund operations and $2.9 million to fund capital expenditures, consisting mostly of payments for assets purchased in 2019.

08:06 EDT Hamilton Beach provides update on operation due to COVID-19 - Our top priorities have been to protect the health and safety of our employees as we strive to meet the needs of our customers and consumers, and to navigate the challenges," said Gregory Trepp, president and CEO. "Our team has responded and adapted quickly as we manage through this unprecedented set of circumstances. We're fortunate to be a leader in an industry that has solid ongoing demand for small kitchen appliances, as homebound consumers work to meet basic needs for food and beverage preparation. Our investments in brands, category expansion, global infrastructure and team members are enabling us to maximize our performance. We expect to navigate and emerge from this crisis on solid ground," said Mr. Trepp. Across the company, a broad range of policies and procedures have been implemented to ensure that employees across all locations remain healthy while meeting business needs to the degree possible. As of March 16, all employees who can work remotely have done so. Some of the company's employees are needed to work on-site in distribution and customer service facilities and in engineering and research labs. The company is taking many precautions to keep them safe and healthy by implementing safeguards such as providing gloves and masks, maximizing distances between people, enhancing cleaning during and between shifts, limiting workplace access and screening necessary visitors and delivery personnel. The on-site situation is monitored daily to ensure a balance between the needs of the business and the needs of team members. To date, no employees at any location have contracted the virus. No issues have emerged to date that are preventing the teams from conducting business. The vast majority of the company's third-party suppliers are now operating at full capacity and shipping product, and there are no interruptions with ocean freight and trucking. The company is implementing a range of measures to maintain financial flexibility. These measures include eliminating discretionary expenses, including a hiring freeze, and focusing capital spending on critical projects.

08:03 EDT Kiniksa reports data for mavrilimumab in COVID-19 pneumonia - Kiniksa Pharmaceuticals provided additional data from the open-label treatment protocol with mavrilimumab, an investigational fully-human monoclonal antibody that targets granulocyte macrophage colony stimulating factor receptor alpha, in patients with severe coronavirus 2019 pneumonia and hyperinflammation. The company also provided data from the exploratory Phase 2 trial for vixarelimab, an investigational fully-human monoclonal antibody that targets oncostatin M receptor beta, in diseases characterized by chronic pruritus. The mavrilimumab open-label treatment protocol was a prospective, interventional, single-active-arm, single-center pilot experience in Italy. Thirteen non-mechanically ventilated patients with severe COVID-19 pneumonia and hyperinflammation were treated with a single intravenous dose of mavrilimumab upon admission to the hospital. Twenty-six contemporaneous non-mechanically ventilated patients with severe COVID-19 pneumonia and hyperinflammation and with similar characteristics upon admission to the hospital, including comorbidities, baseline inflammatory markers and respiratory dysfunction, were evaluated as a control group. All patients in the treatment protocol received optimum local standard of care, including protease inhibitors and antiviral therapies. Over the course of the 14-day follow-up period, mavrilimumab-treated patients experienced greater and earlier clinical improvements than control-group patients, including earlier weaning from supplemental oxygen, shorter hospitalizations, and no deaths. At day 14 of the follow-up period, 85% of mavrilimumab-treated patients and 42% of control-group patients had attained the clinical improvement endpoint. Mavrilimumab-treated patients reached the clinical improvement endpoint earlier compared to control-group patients. During the 14-day follow-up period, there was a 0% incidence of death in mavrilimumab-treated patients compared to 27% in control-group patients. Eight percent of mavrilimumab-treated patients received mechanical ventilation, compared to 35% of control-group patients. Mavrilimumab-treated patients were discharged from the hospital earlier than control-group patients. Mavrilimumab was well-tolerated in all patients, without infusion reactions. P-values above are unadjusted for multiplicity. Kiniksa is engaged with the U.S. Food and Drug Administration and is preparing for a potential registrational development program for mavrilimumab in COVID-19 pneumonia and hyperinflammation. In parallel, academic investigators in the U.S. and Italy are planning investigator-initiated placebo-controlled studies.

08:00 EDT TearLab to be acquired by Accelmed Partners II, taken private - TearLab announced it has entered into a definitive agreement pursuant to which Accelmed Partners II, or AP-II, will acquire TearLab. In connection with the acquisition, AP-II has agreed to an investment of $25M over two tranches that will occur in conjunction with the company delisting from the "over the counter" OTCQB market and TearLab and its senior secured lender, CR Group, has agreed to restructure the terms of the company's outstanding senior secured indebtedness. Post transaction, TearLab will be a private company and AP-II will be the controlling shareholder. Proceeds from the AP-II investment will be used to pay down a portion of TearLab's existing debt, and fund both organic and inorganic growth opportunities. As part of the transaction, Dr. Geiger will become chairman of the board and Accelmed Partners' General Partner, Lior Shav, who led the transaction, will join the company's board of directors. Seph Jensen, TearLab's CEO, will remain a board member. TearLab's board has unanimously approved the transactions and recommended its shareholders approve the acquisition. Closing of the transaction is subject to approval by TearLab shareholders, which TearLab expects to obtain by written consent this week, the satisfaction of certain closing conditions, and certain termination rights that could be exercised prior to closing. The transaction is expected to close in Q2 and is not subject to any financing condition.

08:00 EDT MyoKardia trading resumes

07:57 EDT OpGen chairman says 'excited' about prospects for the company - OpGen issued two letters to stockholders from new OpGen CEO Oliver Schacht and Chairman of the Board William Rhodes. Rhodes said, in part, "In this exciting time for OpGen, I am honored to have been elected as the Chairman of the Board of the Directors of OpGen following the completion of its business combination transaction with Curetis. After five years as Chairman of the Supervisory Board for Curetis and a 14-year career at Becton Dickinson and Company, where I held several senior leadership positions, I am delighted to be chairing this distinguished Board of Directors and anticipate significant, value-creating opportunities for the company. OpGen has been developing industry leading, AI-powered diagnostics and data-driven solutions serving hospitals and patients successfully for many years. This is a particularly dynamic time for our enterprise as we integrate the two businesses and push to further diversify our product portfolio. Our newly constituted Board consists of six members representing expertise from both companies; there are currently four members named by Curetis and two from the pre-combination Board of OpGen. Changes to the Board include Evan Jones, formally OpGen chairman and CEO to join as a non executive director who will help with the transition. Don Elsey will continue as chair of the audit committee joined by Mario Crovetto and Prabha Fernandes, former Supervisory Board directors of Curetis. Thus, the reconstituted Board of Directors consists of myself, Mr. Schacht, Mr. Jones. Mr. Crovetto, Dr. Fernandes, and Don Elsey. These individuals bring a strong understanding of the diagnostic and AMR space as well as significant finance, healthcare, marketing and business development expertise. I look forward to working with such a diverse and talented group of individuals as we lead the company towards value-creating opportunities. Since the beginning, the cornerstone of success of our pre-combination businesses has been the shared vision and mission to develop, manufacture and commercialize proprietary solutions for rapid, molecular diagnostics of severe life-threatening infectious diseases. Following completion of our combination, our fundamental business now offers a much broader, diversified portfolio of products, platforms and bioinformatic solutions. Not only do our business outlooks and industry goals mirror one another, but our combined management and executive teams complement each other as one new combined team. As we embark on integrating our businesses, teams and products over the coming months, the pace and success of our pipeline rollout will largely be determined by the successful execution of our integration strategies. Additionally, a key driver of the Curetis' core business will be OpGen's existing Nasdaq listing and thereby access to U.S. capital markets. This opportunity provides access to a much broader and deeper pool of capital within the U.S. market, ultimately giving the company a larger platform to drive business and pipeline growth. We are excited about the prospects for the company, as we expect to be able to achieve more sustainable growth combined than as separate entities. We anticipate multiple FDA clearance opportunities and we strive to integrate our premier bioinformatics solutions and databases. We will deploy our PCR platforms such as Unyvero and Acuitas as well as our ARESdb and Lighthouse knowledgebase and offer services and strategic partnering opportunities for our next generation sequencing and AI-powered prediction algorithms. Ultimately, the prospect of having the ability to control our own destiny and steer our proprietary platforms is exciting. This offers partnering, commercial and financing opportunities that will likely provide stockholders with attractive entry and exit opportunities. In conclusion, on behalf of the Board, I thank you for your unwavering support of the new OpGen. We remain committed to our mission and to the hospitals and communities that we serve. 2020 will be an exciting year as we continue to build the business and deliver on our commitment to premier AI-powered solutions to the AMR crisis."

07:55 EDT OpGen CEO expects top-line revenue to continue to grow in years ahead - OpGen issued two letters to stockholders from new OpGen CEO Oliver Schacht and Chairman of the Board William Rhodes. Schacht's letter read in part, "As the newly appointed president and CEO of OpGen I want to take a moment to formally introduce myself and share the vision our new management team has for the company with regards to our business outlook, product pipeline and growth strategy for this year and beyond. This is an exciting time for OpGen, and I very much look forward to working with the entire team through the next phase of its growth...This business combination is centered on achieving high growth while leveraging operational efficiencies and maintaining financial discipline as we press forward toward our primary vision - to help solve the looming AMR crisis while preserving antibiotics as effective weapons through more advanced, rapid diagnostic testing. Our state-of-the-art robotic manufacturing facility in Germany, as well as our strong U.S. sales and marketing team and dedicated European commercial partner support team, will be key assets in our post-combination success. OpGen, with Ares Genetics, has access to even more advanced bioinformatics capabilities that can be leveraged to integrate the company's AMR databases, data analytics and reporting platforms to innovate next-generation sequencing-based solutions for infectious disease diagnostics in the future. These synergies are undoubtedly drivers of the core business and are expected to increase stockholder value. Our mission at OpGen is to develop, manufacture and commercialize novel solutions for rapid, molecular diagnostics of severe life-threatening infectious diseases in hospitalized patients. Our company offers integrated solutions that cover unique and differentiated diagnostics test panels, powerful AI-driven bioinformatics and software tools that help find and track multidrug-resistant microorganisms. Our ability to do so will depend on us achieving certain milestones in the short, medium, and long term, as I'll outline below. We must first complete the post-combination integration between the OpGen and Curetis and Ares Genetics businesses across all international teams within the U.S., Germany and Austria offices, which we are working on with full speed to complete as soon as possible. From a product standpoint, our near-term business rollout includes the anticipation of combining Ares Genetics and Acuitas Lighthouse databases and bioinformatics capabilities to bring a combined offering to customers, partners and labs globally. A key milestone for the company will be the expected near-term FDA clearance decision for our Acuitas AMR Gene Panel diagnostic test. We are working actively with the FDA to address any last remaining open items from the interactive review process. While we anticipate the review process is nearing completion, we still expect COVID-19 related delays to the second interactive response review and final timing is hard to predict at this point. As we work through that FDA process, we will also evaluate and prioritize across the entire OpGen group portfolio of R&D programs, platforms, and product development opportunities to select those that we believe have biggest impact and stockholder value creation potential in the near term as well as longer term growth potential. As we look beyond this year, we will seek to consolidate the existing OpGen and Curetis diagnostic test menu on fewer platforms and anticipate bringing the Unyvero A30 RQ platform to market with strategic partners. The rollout and launch of the Unyvero platform and pneumonia test pending China NMPA approval will be a key milestone for the company. Additionally, we hope to bring the combined OpGen portfolio of products to global markets in Europe, Asia Pacific and other global markets through our strong distribution network that we expect to continue to expand further over time. We will also seek to raise additional capital for OpGen. We will consider all instruments at our disposal in terms of equity, debt, non-dilutive grant funding as well as partnering and licensing models as a source of further non-dilutive funding with the consistent goal of optimizing stockholder value. In closing, I am confident that we will be able to establish OpGen as an industry leader in the fight against AMR. We anticipate this business combination will maximize value for our stockholders through a broad and exciting product portfolio with proprietary assets for developing and commercializing innovative, data-driven solutions in infectious disease diagnostics. We anticipate for these reasons our top-line revenue will continue to grow in the years ahead as we use operational efficiencies and synergies to reduce cash burn. Together, with your continued support, we aim to create sustainable stockholder value and expand our proprietary product portfolio capabilities through seeking opportunities that present significant growth potential for the company."

07:53 EDT Virgin Group may offer, sell up to 25M Virgin Galactic shares - Virgin Group, through its subsidiary Vieco 10, announced that it may offer and sell up to 25M shares of its common stock in Virgin Galactic to or through Credit Suisse Securities as sales agent or principal. VGH filed an amendment to its registration statement on Form S-1 with the SEC to register the proposed offering by Vieco 10. Sales of the shares of common stock are expected to be made from time to time by means of ordinary brokers' transactions on the NYSE or otherwise at market prices prevailing at the time of sale, at prices related to prevailing market prices or at negotiated prices. Virgin intends to use any proceeds to support its portfolio of global leisure, holiday and travel businesses that have been affected by the unprecedented impact of COVID-19.

07:51 EDT Telos Corp announces Xacta for Microsoft Azure - Telos Corporation (TLSRP) announced the integration of Xacta into Microsoft (MSFT) Azure Government and Azure Government Secret to accelerate risk management and compliance processes. Xacta integrates with Azure Policy and Blueprints, enabling customers to centrally manage compliance policies, track their compliance status, and enforce policies to ensure compliance going forward. Xacta can analyze IT asset information collected seamlessly from workloads and systems, enabling greater efficiency when moving workloads to Azure. Xacta can also automatically inherit common security controls from Azure via provider projects. Xacta streamlines and automates many labor-intensive tasks associated with key security frameworks such as the NIST Risk Management Framework, NIST Cybersecurity Framework, FedRAMP, and ISO 27001. By integrating with Xacta, Azure Policy automatically generates a large portion of the required accreditation package, reducing the manual effort required of authorizing officials and freeing up their time to focus on making critical risk decisions.

07:49 EDT Moleculin Biotech provides additional comments on trading suspension - Moleculin Biotech announced that since the May 1 temporary suspension by the Securities and Exchange Commission of trading in the securities of Moleculin Biotech, additional information has come to the company's attention regarding claims disseminated by third parties. The company said, "Moleculin has learned that certain third parties made claims and distributed information during the period between March 20th, 2020 to May 5th, 2020 about the potential efficacy and clinical development of WP1122 with respect to coronavirus. The Company neither solicited, had advance knowledge of, nor played any role in the preparation of such information, claims or statements. Moleculin encourages all investors and persons of interest to look at the Company's releases and filings regarding the potential development of WP1122 for the treatment of COVID-19. The SEC's suspension of trading Moleculin stock is scheduled to terminate at 11:59 p.m. ET on May 15th, 2020."

07:48 EDT AnPac Bio granted new U.S. patent for disease detection - AnPac Bio-Medical Science announced the allowance by the United States Patent and Trademark Office on May 6 of a new U.S. patent for a novel medical device for disease detection utilizing integrated circuit technology. By using the said medical device, improved detection performance can be obtained.

07:45 EDT Inspire Medical announces release date fro final LCD policy covering therapy - Inspire Medical Systems announced that Palmetto GBA has announced the release date of June 21, 2020, for its final Local Coverage Decision policy covering Inspire therapy. Palmetto was the only remaining Medicare Administrative Contractor to have not either issued its final LCD policy or set a release date. Palmetto covers Medicare-aged individuals in Alabama, Georgia, North Carolina, South Carolina, Tennessee, Virginia, and West Virginia. In addition to Palmetto, Inspire recently announced that Wisconsin Physicians Services Government Health Administrators issued the effective date of June 14, 2020 for its final LCD. WPS covers Medicare patients in Indiana, Iowa, Kansas, Michigan, Missouri, and Nebraska. The seven Medicare policies state that U.S. Food and Drug Administration-approved hypoglossal nerve neurostimulation is considered medically reasonable and necessary for the treatment of moderate to severe OSA when certain criteria are met. There are approximately 40 million Medicare-aged patients, and an additional 20 million lives covered under commercial Medicare plans, known as Medicare Advantage.

07:42 EDT MyoKardia Phase 3 EXPLORER trial meets primary, secondary endpoints - MyoKardia announced positive topline data from the company's Phase 3 pivotal EXPLORER-HCM clinical trial of mavacamten for the treatment of patients with symptomatic, obstructive hypertrophic cardiomyopathy. Mavacamten demonstrated a robust treatment effect: the primary and all secondary endpoints of the EXPLORER trial were met with statistical significance. Mavacamten was well tolerated, and meaningful improvements in symptoms, functional status and quality of life, as well as reduction or elimination in obstruction of the left ventricle, were observed among patients on treatment versus placebo. The 30-week treatment with mavacamten resulted in a highly statistically significant outcome relative to placebo for the primary endpoint in the EXPLORER-HCM trial, a composite functional analysis designed to capture the treatment effect of mavacamten relative to placebo on both symptoms and cardiac function. All secondary endpoints also demonstrated statistically significant and clinically meaningful improvements for mavacamten as compared to placebo. Secondary endpoints in the EXPLORER-HCM trial evaluated improvements in post-exercise left ventricular outflow tract peak gradient, New York Heart Association functional classification, peak VO2, the Kansas City Cardiomyopathy Clinical Summary Score, and the HCM Symptom Questionnaire Shortness of Breath Domain Score. Mavacamten was well tolerated and demonstrated safety results comparable to placebo, with no new findings observed. Ninety-eight percent of patients enrolled completed the study. Of the two percent who dropped out, none were due to reduced ejection fraction or symptoms of heart failure. Overall rates of adverse events, serious adverse events, and cardiac adverse events, including atrial fibrillation, were comparable for patients treated with mavacamten and placebo. The EXPLORER-HCM clinical trial is part of MyoKardia's pivotal program studying mavacamten as a treatment for symptomatic, obstructive hypertrophic cardiomyopathy. MyoKardia plans to submit a New Drug Application to the U.S. Food and Drug Administration in the first quarter of 2021. Results from the Phase 3 EXPLORER-HCM clinical trial will be submitted to a future professional meeting in 2020.

07:39 EDT Wave Life Sciences expects additional RNA-editing data in 2020

07:38 EDT Bluebird Bio, Bristol-Myers enter amended BCMA CAR-T collaboration agreement - bluebird bio (BLUE) announced that it has amended its existing co-promotion/co-development agreement with Bristol Myers Squibb (BMY) to enable the companies to focus their efforts on efficient commercialization of idecabtagene vicleucel in the U.S., the companies' lead investigational B-cell maturation antigen, or BCMA,-directed chimeric antigen receptor, or CAR, T cell immunotherapy, currently in review with the FDA. The companies will continue to share equally profits and losses in the U.S. Under the terms of the amended agreement, BMS will buy out its obligations to pay bluebird bio future ex-U.S. milestone and royalty payments for ide-cel and bb21217, the companies' second BCMA-directed CAR T immunotherapy, for a one-time upfront payment of $200 million. bluebird bio is currently in the process of building out and qualifying its wholly-owned manufacturing facility in Durham, North Carolina for the production of lentiviral vector, or LVV, to support the U.S. commercial market for ide-cel and for bluebird bio's pipeline. Over time, BMS will assume responsibility for manufacturing of LVV outside the U.S.

07:37 EDT Wave Life Sciences to initiate clinical development of C9orf72 in 2H20

07:37 EDT Wave Life Sciences provides update on PRECISION-HD programs - PRECISION-HD programs for Huntington's disease: Wave is developing a unique portfolio of investigational stereopure oligonucleotides designed to selectively target the mutant allele of the huntingtin gene, while leaving the wild-type relatively intact. PRECISION-HD2: The PRECISION-HD2 Phase 1b/2a clinical trial, Wave's clinical trial investigating WVE-120102, a stereopure oligonucleotide designed to selectively target the mHTT mRNA transcript that contains the SNP rs362331 for HD, is ongoing. Data from the 32 milligram dose cohort of the PRECISION-HD2 trial are currently expected in the second half of 2020. An open-label extension study open to patients outside of the U.S. who participated in the Phase 1b/2a PRECISION-HD2 trial is ongoing. PRECISION-HD1: In March 2020, Wave initiated a 32 mg dose cohort in the ongoing PRECISION-HD1 Phase 1b/2a clinical trial of WVE-120101, a stereopure oligonucleotide designed to selectively target the mHTT mRNA transcript that contains the SNP rs362307 for HD. Wave currently expects to deliver topline clinical data from the PRECISION-HD1 trial, including the 32 mg dose cohort, in the second half of 2020. An open-label extension study open to patients outside of the U.S. who participated in the Phase 1b/2a PRECISION-HD1 trial is ongoing. PRECISION-HD trials: Wave continues to work closely with the PRECISION-HD clinical trial sites to monitor the impact of the evolving COVID-19 pandemic. If global restrictions continue or worsen, the ability to evaluate patients in both of the PRECISION-HD trials as planned may be impacted. Wave is assessing the potential for a next higher dose cohort to be added to both PRECISION-HD trials.SNP3 program for HD: Wave is advancing a third HD program, which is designed to selectively target an undisclosed

07:36 EDT Contura Energy announces most temporary idlings completed or shortened - As the company announced on April 3, certain operations were temporarily idled in response to market conditions, inventory levels and expected customer deferrals. These temporary idlings have since been completed or shortened, and as of May 4, all Contura sites are back to nearly normal staffing levels and operating capacity with additional precautions in place to help reduce the risk of exposure to COVID-19.

07:33 EDT PulteGroup povides COVID-19 update, announces furloughs, layoffs - PulteGroup provided an update on actions the company has taken in response to the COVID-19 pandemic. "As part of our first quarter earnings release, we reported that following a very strong start to the year, housing demand slowed materially beginning in mid-March as the country was impacted by the COVID-19 pandemic," said Ryan Marshall, PulteGroup President and CEO. "In response to the pandemic, we quickly modified our sales, construction and administrative processes to allow our business to operate while protecting the health and safety of our customers, trade partners and employees. After an initial significant contraction in housing demand, recent sales trends have been more encouraging as weekly net new orders went from approximately 140 homes in the last week of March to almost 400 homes in the final full week of April that ended May 3," added Marshall. "While order rates have improved, our net new orders for the month of April were still down approximately 50% from the prior year, so we have taken steps to reduce our targeted overhead expense through a combination of layoffs, furloughs and other cost cutting initiatives. The steps we have taken are expected to reduce overhead expenses by approximately $100 million on an annualized basis, of which approximately $65 million will be realized over the remainder of 2020. We have an outstanding team and employee-oriented culture which makes these actions extremely difficult, but these changes are necessary given the current operating environment. To help support employees impacted by these actions, the company's senior leaders, along with the board, have agreed to temporarily reduce their compensation and the company will redirect the foregone compensation into our employee assistance fund. We have also modified the terms of this fund to significantly broaden the areas of coverage, as well as to make assistance available to any PulteGroup employees who were furloughed or released as part of these recent overhead reductions As a consequence of its actions, the company anticipates taking a second-quarter charge of approximately $10 million for severance and related expenses."

07:31 EDT Regeneron, CCPM announce human genetics research collaboration - Regeneron and the Colorado Center for Personalized Medicine, or CCPM, at the University of Colorado Anschutz Medical Campus announced a large-scale research collaboration designed to advance the field of human genetics and precision medicine through the sharing of 450,000 DNA samples and corresponding health records from de-identified, consented patient participants in the expansive UCHealth system. The Regeneron Genetics Center, or RGC, a wholly owned subsidiary of Regeneron, has entered into the collaboration with CCPM and will sequence these samples, producing genomic data that can be used to facilitate translational medical research and ultimately enable physicians to make better decisions for their patients. The CCPM is one of the largest health data warehouses in the United States and a pioneer in the use of a secure cloud platform with more than 8.7M de-identified patient records. The five-year old research enterprise is also one of the first and largest programs in the country to integrate personalized genomic information with clinical data via a research biobank. CCPM physicians will validate any genetic findings from the RGC data in their CLIA-certified lab, enabling the return of clinically-actionable results to patients.

07:30 EDT AstraZeneca says ENHERTU granted Breakthrough Therapy Designation in U.S. - AstraZeneca and Daiichi Sankyo's ENHERTU has been granted Breakthrough Therapy Designation in the U.S. for the treatment of patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab.

07:27 EDT New York Mortgage Trust receives QT study waiver by FDA for larazotide - 9 Meters Biopharma announced that it has received a thorough QT, or TQT, study waiver as requested by the company from the FDA's Center for Drug Evaluation and Research, pursuant to the company's development of its co-lead Phase 3 larazotide acetate program in celiac disease. The waiver supports the candidate's strong precedent of safety and will potentially streamline the program's timeline and cost-effectiveness. The FDA requires most new chemical entities to be subjected to a randomized dedicated electrocardiogram trial involving normal volunteers, termed a thorough QT study.1 "QT" refers to a specific time interval in the series of electric signals governing the heartbeat, in which the heart's electrical system repolarizes , or 'recharges', after each beat.

07:26 EDT MyoKardia trading halted, news pending

07:23 EDT Recro Pharma says production, shipping functions remain operational - The company said, "During this pandemic, Recro remains committed to our employees and their families, our customers, our suppliers, shareholders and our business partners. Under Pennsylvania and Georgia state and local "shelter-in-place" orders, as a pharmaceutical manufacturer, Recro falls within the category of healthcare operations, which are essential businesses that need to continue during the COVID-19 outbreak. While we are committed to continue providing essential pharmaceutical products to our customers, we are also taking all necessary measures to protect the health and safety of our employees. We have assembled an internal COVID-19 task force to address the continually updated guidance from local, national and international sources to ensure our operations are responding appropriately to the crisis. Recro promptly instituted protocols to have appropriate personnel work remotely. For those employees continuing to support essential operations at our work locations, we have implemented strict social distancing and other protective measures in order to ensure the health of our employees while continuing to provide critical products. We have also restricted business travel and have closed our campus and other facilities to outside visitors and implemented practices that continue GMP compliance while allowing remote staff and auditors to observe key areas and documents by video. Our production, shipping and customer service functions remain operational to allow us to maintain a continuous supply of products to our customers. We are communicating regularly with our suppliers so that our supply chain remains up to date. Our customer service team is operating remotely and remain available to assist our customers and distribution partners as needed."

07:20 EDT Amag Pharmaceuticals pauses patient enrollment in AMAG-432 Phase 2b/3a trial - The COVID-19 pandemic is an evolving situation and is having a serious impact on clinical trials globally. The AMAG-423 Phase 2b/3a clinical trial is a hospital-based trial and all sites have paused new patient enrollment. The company has had to pause initiation of new sites due to the pandemic, significantly impacting recruitment and enrollment. AMAG continues to work with the FDA to initiate the ciraparantag Phase 2b trial in healthy volunteers in the U.S. However, the COVID-19 pandemic has forced the clinical trial sites where the company expected to conduct the trial to close.

07:19 EDT Amag Pharmaceuticals says FDA still reviewing matter of Makena - In response to the company's request to the FDA for a meeting to discuss the future of Makena, the FDA indicated that it was premature to meet at this time as it was still reviewing the matter. AMAG remains committed to working collaboratively with the FDA to maintain access to Makena for eligible pregnant women.

07:18 EDT AMC rallies 32% to $5.52 after Daily Mail says Amazon held buyout talks

07:16 EDT Evelo Biosciences announces upcoming key milestones - Given the ongoing COVID-19 pandemic and its current and anticipated impact on clinical site initiation and patient recruitment, Evelo is revising milestone guidance for EDP1815 in psoriasis and EDP1867 in atopic diseases. The company now expects to achieve the following near-term milestones across its portfolio: EDP1815: Phase 2 data from EDP1815-205, an Evelo-sponsored COVID-19 trial, in 2H 2020. Initiation of a Phase 2 trial for EDP1815 in mild to moderate psoriasis in 3Q 2020. Interim Phase 2 data readout for EDP1815 in mild to moderate psoriasis by mid-2021. EDP1867: Initiation of Phase 1b trial of EDP1867 in atopic diseases in 1Q 2021. EDP1503: Clinical data from a cohort of individuals with TNBC in the Phase 1/2 trial of EDP1503 in 2H 2020.

07:13 EDT Evelo Biosciences selects enteric capsule formulation o EDP1815 for evaluation - Evelo announced the results of two additional clinical studies with EDP1815. Based on these data, Evelo has selected the enteric capsule formulation of EDP1815 for evaluation in its Phase 2 trial in mild to moderate psoriasis. This study will evaluate three doses of the enteric capsule formulation of EDP1815 versus placebo in approximately 225 individuals with mild to moderate psoriasis. The primary endpoint will be mean reduction in PASI score at 16 weeks. Evelo announced positive clinical data from a healthy volunteer immunopharmacology trial with EDP1815. Healthy volunteers were dosed daily for 28 days with the enteric capsule formulation of EDP1815 or placebo in a clinical version of the preclinical delayed type hypersensitivity challenge trial. Treatment with EDP1815 resulted in a greater than 15-fold reduction in the inflammatory reaction, compared to placebo. This is a reduction in the inflammatory response of over 90%, and further evidence of the potential anti-inflammatory effects of EDP1815 with the enteric capsule formulation. Evelo also announced interim data from cohorts of individuals with either mild to moderate psoriasis or atopic dermatitis who were treated with the newer, alternate formulation of EDP1815 in the ongoing Phase 1b studies. Meaningful clinical responses were not observed in either cohort. Based on these data, Evelo is discontinuing development of the alternate formulation.

07:09 EDT Marriott says there are improving occupancy trends in Greater China - CEO Arne Sorenson said, "The resilience of travel demand is evident in the improving trends we see in Greater China. Occupancy at our hotels in the region reached 25 percent in April, up from less than 10 percent in mid-February 2020. Looking at our occupancy and booking trends, it appears that lodging demand in most of the rest of the world has stabilized, albeit at very low levels. Occupancy was around 20 percent over the past two weeks in North American limited-service hotels, benefitting from leisure and drive-to demand. As national, state and local restrictions around travel and business are gradually relaxed, we are preparing to welcome back our associates and guests. A large, and very important, part of that process is addressing their health and safety concerns while on property. To that end, we are rolling out a multi-pronged platform to elevate cleanliness standards and hospitality norms to respond to the new health and safety challenges presented by the current pandemic environment. Hotel owners continue to show their preference for our brands. Rooms signed during the quarter were in line with the year ago quarter, and our development pipeline grew slightly to nearly 516,000 rooms, with 45 percent under construction. At the end of the first quarter, our rooms distribution around the world in 134 countries and territories had grown by 4.4 percent compared to one year prior. While we expect COVID-19's dramatic impact on the global economy will likely result in significantly lower new room openings than we had budgeted for 2020, we are already seeing an uptick in owner interest in discussing conversions to our brands. We have taken substantial steps to preserve liquidity and mitigate the impact of these extremely low levels of demand. In addition to reducing our operating expenses dramatically, in mid-April we issued $1.6 billion of senior notes and, last week, we announced amendments to our existing co-brand credit card agreements with JPMorgan Chase & Co. and American Express, raising $920 million of additional liquidity. We are confident we have sufficient resources to manage through this evolving situation. Our thoughts are with everyone who has been impacted by the pandemic. These are extremely challenging times, but I am confident that we will be able to successfully navigate through them."

07:07 EDT Passage Bio announces anticipated upcoming milestones - Initiate a Phase 1/2 trial for the lead program, PBGM01, for the treatment of patients with infantile GM1 in fourth quarter of 2020. Continue to advance the lead programs PBFT02, for the treatment of frontotemporal dementia and PBKR03, for the treatment of Krabbe disease toward clinical study initiation in the first half of 2021. Continue to advance PBML04, PBLA05 and PBCM06 toward Investigational New Drug-enabling studies.

07:05 EDT Protalix: BRIDGE study successfully met main safety, efficacy objectives - Protalix BioTherapeutics (PLX) announced topline results from its Phase III BRIDGE clinical trial of pegunigalsidase alfa, or PRX-102. Pegunigalsidase alfa is the company's plant cell-expressed recombinant, PEGylated, cross-linked alpha-galactosidase-A product candidate under development for the treatment of Fabry disease. The BRIDGE study was a Phase III 12 month open-label, single arm switch-over study evaluating the safety and efficacy of pegunigalsidase alfa, 1 mg/kg infused every two weeks, in up to 22 Fabry patients previously treated with agalsidase alfa, marketed by Takeda Pharmaceutical Company Limited (TAK) as Replagal, for at least two years and on a stable dose for at least six months. Topline results of the data generated in the study showed substantial improvement in renal function as measured by mean annualized estimated Glomerular Filtration Rate in both male and female patients who were switched from agalsidase alfa to PRX-102. Consistent with previously announced interim data, PRX-102 was found to be well tolerated, with all adverse events being transient in nature without sequelae. Twenty-two patients were enrolled in the study; two of those patients withdrew early from the study due to hypersensitivity reaction, and 20 of the patients successfully completed the 12-month treatment duration. Eighteen of the patients who completed the study opted to roll over to a long-term extension study and continue to be treated with PRX-102. "The completion of our Phase III BRIDGE study and its subsequent analysis mark a significant milestone towards our goal to establish PRX-102 as a new treatment option for Fabry disease," said Dror Bashan, Protalix's President and Chief Executive Officer. "We are encouraged that the BRIDGE study successfully met its main objectives for safety and efficacy, and we are further motivated to continue our work in progressing pegunigalsidase alfa."

07:03 EDT TerraForm Power 'well-positioned' to ride out COVID-19 pandemic - "All-in-all, we believe that TerraForm Power is well positioned to ride out the COVID-19 pandemic crisis given that 95% of our revenue is generated under long-term contracts, over 90% of our PPA offtakers are either investment grade rated or municipalities with investment grade characteristics, our business is less labor intensive than most other industries and our assets are predominantly operational, which mitigates our exposure to supply chain disruptions."

07:01 EDT Genesco: Johnston & Murphy to start initial reopenings with up to 30 sites

07:01 EDT Genesco provides store reopening plan update - Genesco provided details on store reopening plans as well as business updates in response to the COVID-19 pandemic.On Friday, May 1, 2020, Genesco began reopening some stores where state and local officials have allowed malls to operate. The Company's Journeys business is currently operating in more than 300 locations and anticipates reopening over 400 stores by the end of May. The Company's Johnston & Murphy business plans to begin its initial phase of store reopenings with up to 30 locations reopening this week, up to an additional 40 locations next week, and a more aggressive schedule to follow. Based upon the current plans of state and local governments, we expect many more openings in June. All store locations are operating under enhanced measures to ensure the health and safety of our employees and customers, including requiring employees to wear masks, providing hand sanitizer in multiple locations throughout each store for customer and employee use, enhanced cleaning and sanitation protocols, reconfigured sales floors to promote physical distancing, and modified employee and customer interactions to limit contact.The Company's Schuh business is preparing to safely open stores and eagerly awaiting further direction from local governments before setting a timetable to re-start retail operations. "Genesco will continue its phased approach to reopen stores when the following conditions are met: state and local governments have allowed stores to operate; we believe we can operate safely under our enhanced health and safety measures; and we believe that we can ensure the safety of our employees and customers." Mimi E. Vaughn, Genesco's President and CEO, said, "While we have been pleased with the sales we are experiencing through our e-commerce platforms, we are very excited to once again serve our customers through our stores. Our teams have spent countless hours meticulously preparing for the reopening of our stores in the right way with safety and health as our highest priority." Safe Harbor Statement

06:59 EDT Zynerba sees topline results from CONNECT-FX trial late in Q2

06:57 EDT Under Armour: Impacts of COVID-19 can't be reasonably estimated at this time - Under Armour said: "Following the withdrawal of our 2020 outlook on April 3, local market policies and procedures required to decrease COVID-19 transmission remain largely unchanged around the world. Accordingly, due to the high level of uncertainty with respect to the duration and scope of this current event, the quantification of negative impacts on our financial and operating results cannot reasonably be estimated at this time."

06:55 EDT Coty and KKR announce strategic partnership, MOU for KKR to acquire 60% of Wella - Coty (COTY) announced a strategic partnership with KKR (KKR) which will provide the company with an initial investment of $750M through the sale of convertible preferred shares to KKR. Additionally, Coty and KKR signed a memorandum of understanding, or MOU, for the sale of a majority in Coty's professional beauty and retail hair businesses including the Wella, Clairol, OPI and ghd brands at a contemplated enterprise value of $4.3, or 12.3x 2019 EBITDA. Under the terms of the MOU, Coty will carve out Wella into a standalone company in which KKR will acquire a 60% stake and Coty will retain the remaining 40% interest. The contemplated majority divestment of Wella would result in Coty receiving additional cash proceeds of approximately $3B. On signing of the Wella transaction, KKR will also make an incremental convertible preferred investment of $250M in Coty. Together with the initial $750M investment, these transactions will result in significant deleveraging of Coty's balance sheet and position the company for growth and investment in its core portfolio. Coty's mass beauty business in Brazil will remain a fully owned business of Coty. Effective immediately, Coty has agreed to issue $750M of convertible preference shares and KKR is fully subscribing to the issue. These shares will carry a coupon of 9% and will be convertible into Coty shares at $6.24, equating to a 20% premium to Coty's closing stock price on May 8 of $5.20. KKR will be entitled to two seats on Coty's board following the completion of the transaction. KKR is making its investment primarily from its flagship North American and European private equity funds, Americas Fund XII and European Fund V.

06:52 EDT AstraZeneca reports Enhertu granted Breakthrough Therapy Designation in U.S. - AstraZeneca and Daiichi Sankyo Company's Enhertu has been granted Breakthrough Therapy Designation in the U.S. for the treatment of patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab, the companies announced. Jose Baselga, Executive Vice President, R&D Oncology, said: "Current therapy options are limited for patients with HER2-positive metastatic gastric cancer and for those who relapse, there are no approved HER2-targeted medicines. We look forward to working with the FDA to further explore the potential of Enhertu to become an important new treatment and the first antibody drug conjugate for this devastating disease." Enhertu received SAKIGAKE designation in March 2018 by Japan's Ministry of Health, Labour and Welfare for potential use in the same HER2-positive gastric cancer patient population and was recently submitted to the MHLW for approval. This is the second BTD granted for Enhertu in the US. Enhertu received BTD in 2017 for HER2-positive metastatic breast cancer and received approval in December 2019.

06:49 EDT U.S. Well Services says 'duration of market turmoil remains uncertain' - The rapid slowdown in global economic activity in reaction to the COVID-19 pandemic has created both an unprecedented collapse in demand for crude oil and a deteriorating imbalance between global inventories and demand. In response, U.S. E&P companies have not only significantly reduced completions activity, but have also taken steps to shut in existing production. Although U.S. Well Services expects that demand and activity will recover from current levels, the duration of the current market turmoil remains uncertain.

06:41 EDT AMC extends rally, up 24% to $5.07 after Daily Mail report of Amazon talks

06:37 EDT Rocky Mountain Chocolate suspends quarterly dividend amid COVID-19 pandemic - Rocky Mountain Chocolate provided an update regarding the impact of the novel coronavirus pandemic and related global economic conditions on the company's business. The company is also announcing certain actions that management and the company's board are implementing to enhance the company's liquidity given the business disruptions and current global economic conditions resulting from the COVID-19 pandemic, including the vast mandated self-quarantines and closures of non-essential business throughout the United States and around the world. As of May 11, the company, its subsidiaries and its franchisees operated 419 Rocky Mountain Chocolate Factory and self-serve frozen yogurt stores in 40 states, Canada, South Korea, Qatar, the Republic of Panama and The Republic of the Philippines. Nearly all stores have been directly and negatively impacted by public health measures taken in response to the COVID-19 pandemic, with nearly all locations experiencing outright closures, reduced operations or lower sales as a result of, among other things, modified business hours and mall closures, and general changes in consumers' economic activity during the COVID-19 pandemic. As a result, franchisees and licensees are not ordering products for their stores in line with forecasted amounts. This trend has negatively impacted, and is expected to continue to negatively impact the company's business and results of operations, including, among other things, factory sales, retail sales and royalty and marketing fees. In addition, the board has decided to suspend the company's first quarter cash dividend payment to preserve cash and provide additional flexibility in the current environment. Furthermore, the board has suspended future quarterly dividends until the significant uncertainty of the current public health crisis and global economic climate has passed and the board determines that resumption of dividend payments is in the best interest of the company and its stockholders.

06:34 EDT Bright Scholar to acquire 51% equity interest in Linstitute, terms undisclosed - Bright Scholar announced that it has entered into an agreement to acquire 51% equity interests in Linstitute. Linstitute offers outcomes-focused online training services including Academic Olympiad and other international courses. Since its opening in March 2017, the Institute has helped over 2,000 students with more than 120 Academic Olympiad and international courses through its online platform. The Institute offers a comprehensive selection of academic courses covering Mathematics, Physics, Chemistry, Biology, Computing Science and Modeling as well as other services such as summer school application and overseas study counselling.

06:26 EDT Arbutus Biopharma initiates program to find medicines to treat COVID-19 - During Q1, and under the direction of Arbutus' chief scientific officer, Michael Sofia, the company has initiated an internal research program to identify new small molecule antiviral medicines to treat COVID-19 and future coronavirus outbreaks. Sofia brings extensive antiviral drug discovery experience to this new program. Arbutus has also joined forces with the COVID R&D consortium to further support and expedite efforts to address the COVID-19 pandemic. The establishment of the COVID-19 effort does not impact Arbutus' current cash burn guidance for 2020 of $54M-$58M. Michael Sofia, chief scientific officer of Arbutus stated, "While our core mission at Arbutus is to find a cure for hepatitis B, the magnitude of the coronavirus pandemic is undeniable. Given our proven expertise in the discovery of new antiviral therapies, we feel compelled to work towards the discovery of a new treatment. To that end, we have assembled an internal team of expert scientists, with proven track records in bringing new antiviral medicines to market, to identify novel small molecule therapies to treat COVID-19. We have also recently joined forces with the COVID R&D consortium to further support and expedite efforts to address the SARS-CoV-2 pandemic and any future coronavirus outbreaks." At this time, Arbutus' COVID-19 research program will focus on the discovery and development of new molecular entities that address specific viral targets including the nsp12 viral polymerase and the viral protease. These targets are essential viral proteins which Arbutus has experience in targeting.

06:16 EDT Oyster Point Pharma announces ONSET-2 study meets primary, secondary endpoints - Oyster Point Pharma announced top-line results from the Phase 3 ONSET-2 study in dry eye disease. The ONSET-2 trial met the primary endpoint, where a greater percentage of subjects treated with 0.6 mg/ml and 1.2 mg/ml of OC-01 gained greater than 10 mm on Schirmer's score, a measure of tear film production, compared to control. Key secondary endpoints were met, including an improvement in eye dryness score, or EDS, in the normal clinic environment as well as mean change in Schirmer's score in the 1.2 mg/ml dose group. The ONSET-2 Phase 3 trial was a multicenter, randomized, double-masked, vehicle-controlled clinical trial designed to evaluate the safety and efficacy of OC-01, or varenicline, nasal spray for the signs and symptoms of dry eye disease. The study enrolled 758 subjects at 22 centers in the United States and investigated two doses of OC-01 nasal spray, 0.6 mg/ml and 1.2 mg/ml, as compared to control nasal spray. Subjects were administered OC-01 nasal spray twice daily for four weeks. For the primary endpoint, both tested doses of OC-01 showed a statistically significant improvement in subjects gaining greater than 10 mm in Schirmer's score at Week four as compared to control. In the 0.6 mg/ml subject dose group, the percentage of subjects gaining greater than10 mm on Schirmer's score was 44%. In the 1.2 mg/ml subject dose group, the percentage of subjects gaining greater than10mm on Schirmer's score was 47%. In the control group, the percentage of subjects gaining greater than10mm on Schirmer's score was 26%.Additionally, consistent with the ONSET-1 clinical trial, there was a statistically significant improvement in mean change in Schirmer's score at Week 4 in both doses tested as compared to control. In the group of subjects treated with the 0.6 mg/ml dose at Week 4, the mean change from baseline in Schirmer's score was 11 mm. In the 1.2 mg/ml dose group at Week 4, the mean change from baseline on Schirmer's score was 11.2 mm. Mean change from baseline on Schirmer's score in the control group was 5.9 mm. Multiple secondary endpoints were assessed in ONSET-2 including measurement of symptoms in the normal clinic environment as well as in a controlled adverse environment chamber. Eye Dryness Score measured in the normal clinic environment demonstrated statistically significant results in the 1.2 mg/ml dose group at Week 4, although the 0.6 mg/ml dose was not statistically significant. The 0.6 mg/ml and 1.2 mg/ml doses of OC-01 nasal spray did not meet the secondary endpoint for patient-reported symptoms of eye dryness in the Controlled Adverse Environment, or AE, at Week 4. However, both OC-01 doses exhibited a directional benefit as compared to control. The statistical power for assessing this endpoint was negatively impacted by a decrease in the sample size due to the subjects being unable to be assessed as a result of the coronavirus pandemic. In addition, there were a number of subjects who did not meet criteria for treatment in the chamber, which further reduced statistical power. Additionally, the 0.6 mg/ml and 1.2 mg/ml dose of OC-01 nasal spray showed statistical significance in Eye Dryness Score measured at Week 2. OC-01 was well-tolerated in the ONSET-2 clinical trial, and the adverse event profile was consistent with the ONSET-1 clinical trial. The most common adverse event experienced in the treatment groups was sneeze, which occurred with 50% of nasal spray administrations, was transient and mild in severity. There were no reports of serious adverse events related to nasal administration. The number of subjects with treatment emergent adverse events related to study drug leading to discontinuation was 2% or less in either treatment group.

06:10 EDT Nemaura Medical announces initial user data from head-to-head CGM comparison - Nemaura Medical announced positive initial user-volunteer data from its head-to-head comparison with an incumbent continuous glucose monitor, or CGM, device. Earlier this year Nemaura announced that following discussions with various healthcare insurers, it was planning head-to-head comparisons with one or more incumbent CGM devices. The aim of these studies was to position sugarBEAT as a cost-effective, flexible alternative to marketed invasive CGM, allowing continuous glucose monitoring on days the user chooses, and therefore, the company believes, reducing the overall cost burden to users and healthcare insurers alike. The company reported early results comparing data between sugarBEAT and an incumbent CGM device, demonstrating sugarBEAT accuracy comparable to the incumbent CGM device, using a single finger stick calibration. Nemaura also plans to launch proBEAT in the USA later this year, which is expected to help users improve their knowledge of how a range of lifestyle, dietary and health and wellbeing factors impact their sugar levels by deploying sugarBEAT to act like a black box flight recorder. It is planned that big data about the multitude of factors that affect glucose levels will be gathered from all users and employed in developing and subsequently "fine-tuning" predictive algorithms and artificial intelligence based feedback and prompts. The company believes that these will then be able to both educate and provide motivational tools to the user to encourage them to lead a healthier lifestyle, targeting over 85M people that are pre-diabetic and over 24M people who have Type 2 diabetes in the U.S. Nemaura is intending to pursue reimbursement from healthcare insurers in the U.S. for proBEAT.

06:06 EDT Act II Global Acquisition reaffirms Whole Earth brands transaction - Act II Global Acquisition Corp. announced that it entered into an agreement on May 8, 2020 to revise certain terms of its previously announced purchase agreement with certain affiliates of MacAndrews & Forbes Incorporated related to the proposed purchase of the business and operations of Merisant Company and MAFCO Worldwide LLC. The amended transaction terms reflect a valuation of 7.9x pro forma adjusted 2020 EBITDA, compared to 8.5x under the transaction terms announced in February 2020. Following the transaction close, reflecting the revised transaction terms, anticipated net leverage will decrease to 1.4x from 2.0x under the transaction terms announced in February 2020. Under the terms of the amended purchase agreement, the transaction is now valued at approximately $516 million at closing, as compared to approximately $586 million in the agreement announced in February, 2020, reflecting a reduction in the aggregate consideration to be paid to the selling equity holders. Immediately following the closing of the proposed business combination and assuming no redemptions, the Company expects 42.5 million shares of Whole Earth Brands, Inc. common stock, inclusive of those shares issuable to the private placement investors, to be issued and outstanding.

05:59 EDT AMC jumps 7% to $4.39 after Daily Mail report of Amazon takeover talks

05:25 EDT Quotient enters partnership with hVIVO - Quotient and hVIVO, part of Open Orphan, announced that the MosaiQ by Quotient system and MosaiQ COVID-19 Antibody Microarray will be used by hVIVO to screen for SARS-CoV-2 antibodies (COVID-19). Quotient has entered into an exclusive contract with hVIVO, whereby Quotient is hVIVO's exclusive supplier of COVID-19 antibody testing equipment, to support COVID-19 antibody testing in the UK. hVIVO, based in London, UK, is a world leader in the testing of vaccines and antivirals using human challenge study models.