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

18:56 EDT United Airlines strengthens onboard mask policy - United Airlines announced that, along with other Airlines for America members, it will strengthen mandatory mask policies to further mitigate against the spread of COVID-19 and help continue to keep passengers and crew safe. While the overwhelming majority of passengers are complying with United's mandatory policy, starting on June 18, any passenger that does not comply when onboard a United flight will be placed on an internal travel restriction list. Customers on this list will lose their travel privileges on United for a duration of time to be determined pending a comprehensive incident review. United currently requires all passengers to wear a face covering onboard its flights and expects that policy to remain in place for at least the next 60 days. The only exceptions to this policy are individuals who have a medical condition or a disability that prevents them from wearing a face covering, those who cannot put on or remove a face covering themselves and small children. Customers are expected to wear a mask for the duration of the flight, except when eating or drinking.

18:00 EDT Celanese announces vinyl acetate monomer price increases - Celanese Corporation will increase list and off-list selling prices for vinyl acetate monomer. The price increases are for orders shipped and will be effective as of July 1, 2020, or as contracts otherwise allow, and are incremental to any previously announced increases.

17:46 EDT Value Act discloses 5.6% active stake in Nikola, may seek 'further discussions' - As of the date hereof,Value Act may be deemed to be the beneficial owner of 20,362,024 shares of Common Stock, representing approximately 5.6% of Nikola's outstanding Common Stock. All percentages set forth in this Schedule 13D are based upon the Issuer's reported 360,904,478 outstanding shares of Common Stock as of June 3, 2020 as reported in the Nikola's Current Report on Form 8-K dated June 3.Value Act has had and anticipate having further discussions with officers and directors of the Issuer in connection with Value Act's investment in Nikola. This filing allows for activism

17:25 EDT The Valens Company announces custom manufacturing agreement with High12 - The Valens Company announced a custom manufacturing agreement with High12, a cannabis-focused consumer packaged goods company, to develop a line of vape products for the launch of its new brand Daize. Under the terms of the High12 agreement, The Valens Company and High12 will partner for a two-year term with successive one-year renewal options. Further, the parties have collaborated to develop a customized collection of products in partnership with vape solutions provider The Blinc Group to align with the Daize brand identity. The procurement of customized hardware, and the development and manufacturing of the Daize brand portfolio of premium devices and 510 thread cartridges is expected to begin immediately. The High12 agreement will follow a royalty payment structure based on a set of outlined quarterly targets. The Valens Company and High12 expect to initially launch these products in Q3 in Alberta, British Columbia, and Ontario, with the intention to expand the offering nationally after that.

17:12 EDT WW amends revolving credit facility to $175M from $150M - The company has amended its revolving credit facility, increasing the commitments to $175M from $150M and raising the consolidated first lien net debt leverage ratio required by the financial maintenance covenant, together providing for significantly more flexible access to liquidity. On June 5, 2020, WW fully repaid the loans outstanding on its revolver, which it previously drew down as a precautionary measure in light of the COVID-19 outbreak. Following this repayment, the Company had a strong cash balance of $127 million, as of June 5, 2020.

17:10 EDT WW anticipates approximately 400 Studios in the U.S. will be open by June 30

17:02 EDT Apple says App Store ecosystem supported $519B in billings, sales in 2019 - Apple announced the App Store ecosystem supported $519B in billings and sales globally in 2019 alone. The new study, conducted by independent economists at Analysis Group, found that the highest value categories were mobile commerce apps, digital goods and services apps, and in-app advertising. The study reveals that the direct payments made to developers from Apple are only a fraction of the vast total when sales from other sources, such as physical goods and services, are calculated. Because Apple only receives a commission from the billings associated with digital goods and services, more than 85% of the $519B total accrues solely to third-party developers and businesses of all sizes. "The App Store is a place where innovators and dreamers can bring their ideas to life, and users can find safe and trusted tools to make their lives better," said Tim Cook, Apple's CEO. "In a challenging and unsettled time, the App Store provides enduring opportunities for entrepreneurship, health and well-being, education, and job creation, helping people adapt quickly to a changing world. We're committed to doing even more to support and nurture the global App Store community - from one-developer shops in nearly every country to businesses that employ thousands of workers - as it continues to foster innovation, create jobs, and propel economic growth for the future." Of the $519B the App Store ecosystem supported in 2019, the study found that sales from physical goods and services accounted for the largest share, at $413B. Within that category, m-commerce apps generated the vast majority of sales, and of those, retail was the largest, at $268B. Retail apps include those that digitally represent brick-and-mortar stores such as Target and Best Buy, as well as virtual marketplaces that sell physical goods, such as Etsy, but do not include grocery delivery, which is its own category.

16:52 EDT Nikola falls 8% to $63.00 after 53.39M share common stock offering

16:44 EDT Lennar sees Q4 new orders 12,000 - 12,250 - Sees Q4: Deliveries of 14,300 - 14,600; Average Sales Price of $380,000; Gross Margin % on Home Sales 21.75% - 22%.

16:41 EDT Lennar sees 2020 deliveries of 50,500 - 51,000 homes - Stuart Miller, Executive Chairman of Lennar, said, "While many parts of the economy are still waiting to open and rebound, the housing market has proven to be resilient in the current environment. We expect this trend to continue and for housing to be a significant driver of employment and rebound for the broader economy. In this context, we are re-instituting guidance for fiscal year 2020 and now expect our deliveries to be in the range of 50,500 - 51,000 homes with a gross margin on home sales of approximately 21.5% and a net margin on home sales of approximately 13.0%."

16:39 EDT Mustang Bio CEO Litchman purchases $500K in company shares - Mustang Bio CEO Manuel Litchman purchased 153,846 shares of company stock at an average price of $3.25 on June 11. The total transaction amount was $500,000.

16:36 EDT NYSE accepts NTN Buzztime plan to regain compliance, grants plan period - NTN Buzztime announced it received a letter from NYSE Regulation, stating it accepted the company's plan to regain compliance with Section 1003 of the NYSE company guide by September 27, 2021, and granted the company a plan period through September 27, 2021 to regain compliance. In the letter, NYSE regulation also notified the company that it was not in compliance with Section 1003 of the NYSE because the company reported stockholders' equity of less than $4M as of March 31 and had net losses in its five most recent fiscal years ended December 31, 2019. The company is not in compliance with Section 1003 of the NYSE company guide because it reported stockholders' equity of less than $6M as of December 31, 2019 and had net losses in its five most recent fiscal years ended December 31, 2019. The company will be subject to periodic review by NYSE regulation staff for compliance with the company's plan to regain compliance. If the company is not in compliance with the continued listing standards by September 27, 2021, or if the company does not make progress consistent with its plan during the plan period, NYSE regulation staff will initiate delisting procedures as appropriate. The listing of the company's common stock on the exchange is being continued pursuant to an extension.

16:31 EDT Univar, Biosynthetic reach distribution pact for BioEstolide products in U.S. - Univar Solutions announced a new distribution agreement to extend Biosynthetic Technologies' footprint in the beauty and personal care market across the United States. Under the terms of the agreement, Univar Solutions will market, sell, warehouse, and support Biosynthetic Technologies full BioEstolide product line to meet the demand for biobased personal care ingredients. BioEstolide products are bio-based oils with emollient performance features, and are from a natural, non-GMO source. "We are incredibly excited about this recent agreement with Univar Solutions, as our organizations are aligned in our goals and values. We look forward to providing customers in the United States with our BioEstolide(TM) product line, leveraging the excellent reputation of our new partner, Univar Solutions," said Jakob Bredsguard, president of Biosynthetic(R) Technologies Food, Drugs and Personal Care Division. "We are pleased to announce our entrance into the personal care market space with our BioEstolide(TM) products. These new, bio-based esters are manufactured in a facility that runs on sustainable energy. As a biobased alternative to existing petroleum-derived raw materials, we foresee them having a significant impact on the personal care marketplace."

16:21 EDT Guardion Health Sciences names David Evans interim president, CEO - Guardion Health Sciences announced that its Board of Directors has appointed Dr. David Evans, Ph.D. as the company's Interim President and Interim Chief Executive Officer effective immediately. Dr. Evans has served as the company's Chief Science Officer and was the founder of the company's subsidiary, VectorVision. Dr. Evans joined the Guardion Board of Directors effective with the Company's acquisition of VectorVision on September 29, 2017. David Evans succeeds Michael Favish, who is the founder of Guardion and who is stepping down as an officer and employee of Guardion and is also leaving the Board of Directors of Guardion. The Board is conducting an extensive search to identify the company's next Chief Executive Officer and will provide additional information to shareholders as it becomes available.

16:18 EDT Mercury Systems receives $49M order for signal processing and RF technology - Mercury Systems announced that it has received a $49M order from a leading defense prime contractor for high-performance signal processing and RF solutions for a missile defense program. The order was received in the Company's fiscal 2020 fourth quarter and is expected to be shipped over the next several quarters. "This order is one of the largest in the Company's history and reinforces our commitment to Innovation That Matters, delivering superior value and performance that help solve our customer's most complex embedded processing challenges," said Didier Thibaud, Executive Vice President and Chief Operating Officer. "We are dedicated to delivering solutions that provide significant affordability and portability, making commercial technology profoundly more accessible to aerospace and defense."

16:13 EDT T2 Biosystems appoints new board appointments including Qiagen CEO - T2 Biosystems (TTOO) announced three new Board of Director appointments. The three new directors will add significant clinical and commercialization experience and expand board diversity, coupled with a strong understanding of the company's customer base. The new appointments include: Thierry Bernard, Chief Executive Officer, QIAGEN (QGEN); Dr. Ninfa Saunders, President and Chief Executive Officer, Navicent Health; and Robin Toft, Founder and Chief Executive Officer, Toft Group, a ZRG company. "We are thrilled to add to our Board three individuals whose commercial expertise and combined background in molecular diagnostics, clinical care, and life science leadership will bring invaluable perspective and insight to our business, helping us to achieve our goals of accelerating our sales, improving our operations, and advancing our pipeline," said John Sperzel, President and Chief Executive Officer, T2 Biosystems. "Our commitment to developing innovative technology that helps save lives and improve patient outcomes remains steadfast, and adding these three industry leaders will bolster our efforts to accomplish that in the coming months and years."

16:11 EDT Gaming and Leisure, Eldorado announce amendments to master lease agreement - Gaming and Leisure Properties (GLPI) and Eldorado Resorts (ERI) announced that the companies have agreed to amendments to their master lease agreement. The amended and restated master lease is subject to the review of certain gaming regulatory agencies and the expiration of applicable gaming regulatory advance notice periods. Pursuant to the terms of the agreed upon lease amendment, the variable rent construct and the EBITDAR based escalator test in the existing master lease have been eliminated. The portion of the rent subject to escalation will have fixed escalation percentages going forward. Given the backdrop of COVID-19, the companies have agreed upon no rent escalation in each of 2020 and 2021. The fixed escalation term of the master lease will commence with a 1.25% escalation on each of October 1, 2022 and October 1, 2023; followed by a 1.75% escalation on each of October 1, 2024 and October 1, 2025. Beginning on October 1, 2026 and for all subsequent lease years, the master lease will include a 2% fixed annual escalator. In addition, the companies have agreed to extend the master lease's initial term to 20 years with a renewal options of up to an additional 20 years. Further, Eldorado, subject to the satisfaction of certain conditions, can also replace its Tropicana Evansville and/or Tropicana Greenville properties in the master lease with one or more properties from a pre-determined list of existing Eldorado properties, provided that the aggregate replacement value is at least equal to the value of Tropicana Evansville and/or Tropicana Greenville, as applicable. In addition, Eldorado will be permitted to divest of the operations of Belle of Baton Rouge Casino & Hotel, with GLPI having the option to divest of its real property interests in such transaction or retain such interests through a new lease.

16:08 EDT Otonomy provides update on pipeline including Otividex trial in Meniere's - Otonomy provided an update on its product pipeline and the timeline to results for the company's three ongoing clinical trials, including the Phase 3 trial of OTIVIDEX in Meniere's disease. The company will host a conference call and webcast today at 4:30 p.m. ET to review these updates. "We have been able to mitigate the impact of the COVID-19 pandemic on our clinical trials by taking steps to ensure the integrity of data collection from enrolled patients and supporting the increasing number of sites able to reinitiate recruitment of new patients," said David A. Weber, Ph.D., president and CEO of Otonomy. "While the timing of our trial results has been adjusted due to the pandemic, what remains the same is that we have clinical trial catalysts in the coming months for three novel product candidates that each address significant unmet medical needs in neurotology for which there are no FDA-approved drug treatments. We are excited about the transformational opportunity these multiple readouts provide beginning with the announcement of our Phase 2 tinnitus results next month."

16:07 EDT Eldorado signs LOI to enter into $400M mortgage with VICI Properties - Eldorado Resorts, Inc. (ERI) announced it has signed a letter of intent to enter into a $400M mortgage with VICI Properties Inc. (VICI) that is secured by the recently opened Caesars Forum Convention Center in Las Vegas. The 5 year mortgage will bear interest at a rate of 7.7% subject to a 2% annual escalation and will be pre-payable beginning in year 3 subject to certain conditions. The Caesars Forum Convention Center will remain subject to the existing Put/Call Agreement between Caesars Entertainment Corporation (CZR) and affiliates of VICI, with certain modifications, including VICI's call option accelerating to 2025. Additionally, VICI has agreed to acquire approximately 23 acres of undeveloped land parcels adjacent to the center of the Las Vegas Strip for $4.5M per acre, for total proceeds of approximately $103.5M. The total expected proceeds from both transactions is approximately $503.5M. The mortgage and the acquisition of the land parcels are pursuant to a non-binding letter of intent with VICI and the closing of such transactions is conditioned upon the completion of the pending business combination of Eldorado and Caesars and remains subject to completion of due diligence and negotiation of definitive documentation, and other customary closing conditions, including receipt of regulatory approvals. The closing of the loan and the acquisition of the land are intended to occur concurrently in the third quarter of 2020 and are cross conditioned.

16:05 EDT Freddie Mac hires JPMorgan as financial advisor to help exit conservatorship - Freddie Mac (FMCC) announced it has hired JPMorgan (JPM) as a financial advisor to help facilitate the company's recapitalization and exit from conservatorship. The announcement comes following a request for proposal, or RFP, process the company announced in May. J.P. Morgan will provide strategic counsel and perform a range of tasks to help facilitate Freddie Mac's exit from conservatorship, including advice and assistance on valuation analysis, consideration of potential capital structures and assessment of capital raising alternatives.

16:04 EDT Adverum Biotechnologies announces Laurent Fischer M.D. as CEO - Adverum Biotechnologies announced that Laurent Fischer, M.D. has joined the company as its chief executive officer and a member of the board of directors. Leone Patterson, who has served for four years in executive leadership roles at Adverum, most recently as the company's CEO, will continue to serve as the company's president. "We are delighted to welcome an experienced industry leader of Laurent's caliber to our team at Adverum," said Patrick Machado, J.D., Board Chair of Adverum. "The skills that Laurent brings to our company as a physician and experienced public company CEO will be invaluable additions to our existing executive team, and set us up well for future success as we enter the next phase of our growth." Dr. Fischer added, "I am delighted to join the team at Adverum at this pivotal stage of the company's growth. This high-performing team has done a phenomenal job executing on developing ADVM-022, a potential one-time treatment for wet AMD and diabetic macular edem. I believe Adverum can significantly disrupt the anti-VEGF market with ADVM-022, offering a more patient-centric treatment approach to preserve vision in patients with serious ocular diseases. During my career, I have developed and commercialized novel, first-in-class drugs in multiple therapeutic categories with significant unmet medical need. I look forward to providing my strategic experience as we continue the course of making

16:01 EDT Endologix issues correction notice for Ovation iX abdominal stent graft system - Endologix announced that a correction notice has been issued for the Ovation iX system, that identifies the root cause of polymer leaks. This voluntary action has been classified by the FDA as a Class 1 recall. No physical product removal of the product is planned or needed. Correction Z-2263-2020 was issued in May 2020 to current users of the Ovation iX system and informs users of a material weakness adjacent to the polymer fill channel that may become compromised during pressurization with liquid polymer. The clinical sequelae associated with polymer leaks may be systemic or aneurysm related. In addition to new information as to the root cause of leaks, the May 2020 correction notice also contained information regarding the incidence of aneurysm related complications and the lack of long-term sequelae following underfilling of the polymer rings caused by a polymer leak.

15:41 EDT Intelsat announces contracts for new satellites with Maxar, Northrop - Intelsat (I) announced that it has contracted for new satellites with U.S. manufacturers, which it calls "a necessary step to meet the accelerated C-band spectrum clearing timelines" established by the Federal Communications Commission earlier this year. Intelsat has entered into two new agreements; one with Maxar Technologies (MAXR) to build and deliver four satellites, and another with Northrop Grumman (NOC) to build and deliver two satellites. Intelsat is currently in negotiations with manufacturers for a seventh satellite required to support its C-band transition, the company added. "Later this week, Intelsat plans to file its full C-band spectrum transition plan with the FCC in accordance with the FCC's revised timeline. The plan will provide additional manufacturing and launch details for new satellites and outline the steps that Intelsat will take to reconfigure its terrestrial-based infrastructure and to ensure a successful transition," Intelsat added.

15:37 EDT Jazz Pharmaceuticals announces FDA accelerated approval of Zepzelca - Jazz Pharmaceuticals announced along with its partner PharmaMar, that the U.S. FDA approved Zepzelca for the treatment of adult patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy. Zepzelca was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Zepzelca will be commercially available in the U.S. in early July. As previously announced in December 2019, PharmaMar and Jazz entered into an exclusive license agreement, which became effective in January 2020, granting Jazz U.S. commercialization rights to Zepzelca.

15:15 EDT Delta sees July schedule about 70% smaller than same time last year - Delta said in a post to its news hub: "Even with the modest growth in demand, Delta's July schedule will be approximately 70% smaller than the same time last year, including reductions of about 65% for U.S. domestic travel and nearly 75% for international. As Delta looks ahead to the remainder of the summer travel season, the airline will stay focused on adding seat capacity, gradually rebuilding its footprint in local markets and resuming high-demand service suspended due to travel restrictions." Joe Esposito, S.V.P. - Network Planning, added: "While we're rebuilding our network at home and abroad, it's even more critical that we provide the highest industry standard of safety, space and clean so when our customers are ready to travel, we're ready for them." Reference Link

15:13 EDT Delta Air Lines to add almost 1,000 flights system-wide in July - Delta said in a post to its news hub that the company will add almost 1,000 flights system-wide in July, "boosting service and nonstop connectivity to popular summer destinations and major business markets." Delta added: "Customers traveling or considering travel this summer can feel confident in a safe experience throughout the journey, from check-in to baggage claim. Delta has implemented several measures to provide peace of mind at the airport. Additionally, Delta is offering more space for safer travel onboard by capping cabin seating capacity at 60 percent in Main Cabin and 50 percent in First Class and blocking middle seats through Sept. 30, 2020. Customers also have the flexibility to change their plans without a fee for a year, for new flights purchased through June 30." Reference Link

14:52 EDT 93rd Oscars Ceremony pushed to April 25, 2021 from February 28 - The Academy of Motion Picture Arts and Sciences and the ABC Television Network today announced the 93rd Oscars ceremony will move to Sunday, April 25, 2021, as a result of the global pandemic caused by COVID-19. The show, which will air live on ABC, was originally scheduled for February 28, 2021. Coinciding with the Oscars celebration, the Academy Museum of Motion Pictures, initially scheduled to open to the public on December 14, 2020, will now open on April 30, 2021, also as a result of the health crisis. "For over a century, movies have played an important role in comforting, inspiring, and entertaining us during the darkest of times. They certainly have this year. Our hope, in extending the eligibility period and our Awards date, is to provide the flexibility filmmakers need to finish and release their films without being penalized for something beyond anyone's control," said Academy President David Rubin and Academy CEO Dawn Hudson. "This coming Oscars and the opening of our new museum will mark an historic moment, gathering movie fans around the world to unite through cinema." Dates also have shifted for the Academy Awards eligibility period, submission deadlines and related awards season events. The eligibility period for Academy Awards consideration has been extended beyond the standard December 31 deadline: a feature film must now have a qualifying release date between January 1, 2020 and February 28, 2021. The submission deadline for specialty categories (Animated Feature Film, Documentary Feature, Documentary Short Subject, International Feature Film, Animated Short Film, Live Action Short Film) is December 1, 2020. The submission deadline for general entry categories, including Best Picture, Original Score and Original Song, is now January 15, 2021. Reference Link

14:38 EDT Fed to resume examination activities for all banks - The Federal Reserve Board announced earlier that it will resume examination activities for all banks, after previously announcing a reduced focus on exam activity in light of the coronavirus response. "In March, the Board announced that it would focus on outreach and monitoring in light of the coronavirus response measures and temporarily reduce its exam activity, with the greatest reduction for smaller banks. Since that time, banks have had time to implement contingency operating plans and adapt their operations, so exam activity will resume. The Board anticipates that exams will continue to be conducted offsite until conditions improve and will continue to work with banks to understand any specific issues they may be facing," the central bank stated. Publicly traded companies in the space include Bank of America (BAC), Citi (C), Goldman Sachs (GS), JPMorgan (JPM), Morgan Stanley (MS), U.S. Bancorp (USB) and Wells Fargo (WFC).

14:19 EDT Citi reports May credit loss 3.12% vs. 2.96% last month - Reports May 30-plus day delinquencies 1.59% vs. 1.69% last month.

13:57 EDT Co-Diagnostics sued over '100% accurate' COVID-19 test claims - Gelt Trading Ltd. of the Cayman Islands filed a class action complaint alleging securities fraud involving COVID-19 tests versus Co-Diagnostics (CODX), Dwight Egan, James Nelson, Eugene Durenard, Edward Murphy, Richard Serbin, Reed Bensen, and Brent Satterfield at the U. S. District Court for the District of Utah. "Unlike many securities fraud cases, the Co-Diagnostics fraud is blunt and simple to understand," Gelt said in its lawsuit according to Bloomberg. "Co-Diagnostics, its chief technology officer, and its other officers and directors made unequivocal statements to the market that its Covid-19 tests were 100% accurate -- a staggering claim that appeared to set Co-Diagnostics apart from other competitors developing Covid-19 tests." Shares of Co-Diagnostics are up 13% to $17.52 in afternoon trading. Reference Link

13:32 EDT Equitrans Midstreamm EQT Midstream Partners investors approve merger - Equitrans Midstream Corporation (ETRN) and EQM Midstream Partners, LP (EQM) announced that, at a special meeting held earlier Monday, the shareholders of ETRN approved the issuance of shares of ETRN's common stock and shares of ETRN's preferred stock in connection with ETRN's proposed merger with EQM. More than 99% of the total votes cast at ETRN's special meeting were voted in favor of approving the ETRN stock issuance. In addition, at a special meeting held earlier Monday, EQM's limited partners voted to approve the merger agreement in connection with the Merger. The holders of more than 83% of EQM's outstanding limited partner interests voted in favor of approving the merger agreement, and more than 99% of the total votes cast at the special meeting were voted in favor of approving the merger agreement. The Merger is subject to customary closing conditions and is expected to close on June 17, 2020, at which time EQM's common units will no longer be publicly traded on the New York Stock Exchange.

12:59 EDT Former Pinterest executive Ifeoma Ozoma alleges mistreatment - Former Pinterest public policy and social impact manager Ifeoma Ozoma has alleged mistreatment while working at the social media company. In a thread published to Twitter on Monday, Ozoma said she decided to share her story about Pinterest, "which just declared 'solidarity with BLM.' What a joke." She added that "As a Black woman, seeing Pinterest's middle of the night "Black employees matter" statement made me scratch my head after I just fought for over a full year to be paid and leveled fairly. A year in which I: a) was doxxed by a white male colleague - he shared my cell number, photo, & name w/ violently racist/misogynistic parts of the internet (followed up by a dangerously inadequate response from Pinterest - there's so much more to this horrible story). b) continued to serve as the leader of/ spokesperson for Pinterest's biggest Public Policy wins. See: *scores* of articles and interviews on addressing health misinformation, emotional well-being, stopping promotion of plantation wedding venues. c) kept all the above quiet for "professionalism," and in the hope that Pinterest would do the right thing. Instead, they doubled down on retaliation. 1 wild ex: My manager gave me bad perf review feedback for not both-sidesing the promo of slave plantations. I have receipts..." "I am SO proud of the initiatives I led in my time there - addressing health misinfo decisively is no longer novel thanks to that work. I just wish it wasn't sullied by the racism, gaslighting, & disrespect from my manager, skip level, and the company's legal & HR leadership." Reference Link

12:50 EDT Cooperman says market could be in trading range for next few years - Leon Cooperman of Omega Advisors is speaking on CNBC.

12:38 EDT Cooperman sold shares of United Airlines, Carnival - Leon Cooperman of Omega Advisors is speaking on CNBC.

12:29 EDT Biden presidency likely takes $15 off S&P 500 earnings - Leon Cooperman of Omega Advisors is speaking on CNBC.

12:27 EDT eBay says employees indicted had been previously terminated

12:26 EDT eBay says neither company nor any current eBay employee indicted

12:23 EDT S&P 500 Index is fully valued, Leon Cooperman says - Leon Cooperman of Omega Advisors is speaking on CNBC.

12:23 EDT Pennsylvania AG says formally charging Cabot Oil & Gas for environmental crimes - Pennsylvania AG Josh Shapiro tweeted: "My Office is formally charging Cabot Oil & Gas -- a fracking company -- for environmental crimes in Northeastern PA. These charges come as part of a 2-yr Grand Jury investigation." Reference Link

12:21 EDT Cooperman says Mr. Cooper one of his favorite stocks - Leon Cooperman of Omega Advisors is speaking on CNBC.

12:05 EDT Provention Bio announces extended follow-up data from "At-Risk" TN-10 study - Provention Bio announced extended follow-up data showing a single 14-day course of teplizumab significantly delayed the onset of insulin-dependent type 1 diabetes, or T1D, in presymptomatic patients by a median of approximately three years compared to placebo. These new data from the pivotal "At-Risk" TN-10 Study add one year to the two-year median delay that was previously reported in the New England Journal of Medicine and presented at last year's American Diabetes Association's Scientific Sessions, the company said. Teplizumab, Provention's lead drug candidate, is an anti-CD3 monoclonal antibody in development for the delay or prevention of insulin-dependent T1D in presymptomatic patients, defined by the presence of two or more T1D-related autoantibodies and dysglycemia. "Continuing to delay the onset of clinical-stage T1D with just a single course of teplizumab, now by approximately three years as compared to placebo, is profoundly relevant for patients facing a lifetime of insulin dependency, glucose monitoring, and lifestyle challenges to survive. We understand the urgency in fundamentally changing the progression of T1D in early-stage disease - before clinically relevant beta cell loss occurs - and remain steadfast in our commitment to bring teplizumab to the T1D community as quickly as possible," said Ashleigh Palmer, CEO of Provention Bio.

12:01 EDT IBM to acquire Spanugo, terms not disclosed - IBM announced it has signed a definitive agreement to acquire Spanugo, a U.S.-based provider of cloud cybersecurity posture management solutions. IBM said it will integrate Spanugo software into its public cloud.

12:00 EDT EQT Midstream Partners rises 15.1% - EQT Midstream Partners is up 15.1%, or $2.94 to $22.42.

11:55 EDT FDA revokes emergency use authorization for hydroxychloroquine for COVID-19 - In an alert dated June 15, the FDA stated: "Based on FDA's continued review of the scientific evidence available for hydroxychloroquine sulfate and chloroquine phosphate to treat COVID-19, FDA has determined that the statutory criteria for EUA as outlined in Section 564(c)(2) of the Food, Drug, and Cosmetic Act are no longer met. Specifically, FDA has determined that CQ and HCQ are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of CQ and HCQ no longer outweigh the known and potential risks for the authorized use. This warrants revocation of the EUA for HCQ and CQ for the treatment of COVID-19." Mylan (MYL), Teva (TEVA), Novartis (NVS), and Bayer (BAYRY) are among companies that had announced efforts to increase hydroxychloroquine production early in the COVID-19 outbreak. Reference Link

11:32 EDT Lincoln Educational reopens Euphoria Institute in Las Vegas - Lincoln Educational Services announced that it has re-opened its Euphoria Institute of Beauty Arts and Sciences campus in Las Vegas, NV. On-site instruction has resumed on a limited basis. Euphoria Institute has 429 students currently enrolled at the Las Vegas campus, located at 9340 West Sahara Avenue, Suite 205.

11:28 EDT Platinum Group trading halted, news pending

11:02 EDT Microsoft, SAS announce technology, go-to-market strategic partnership - Microsoft Corp. and SAS announced an extensive technology and go-to-market strategic partnership. The two companies will enable customers to easily run their SAS workloads in the cloud, expanding their business solutions and unlocking critical value from their digital transformation initiatives. As part of the partnership, the companies will migrate SAS' analytical products and industry solutions onto Microsoft Azure as the preferred cloud provider for the SAS Cloud. SAS' industry solutions and expertise will also bring added value to Microsoft's customers across health care, financial services and many other industries. This partnership builds on SAS integrations across Microsoft cloud solutions for Azure, Dynamics 365, Microsoft 365 and Power Platform and supports the companies' shared vision to further democratize AI and analytics.

10:54 EDT Mallinckrodt to proceed with appeal despite court decision denying injunction - Mallinckrodt announced its disappointment with the U.S. Court of Appeals for the District of Columbia decision to deny its request for a temporary injunction preventing the U.S. Centers for Medicare and Medicaid Services, or CMS, from enforcing a change in Medicaid drug rebate calculation for Acthar Gel. Mallinckrodt said in a release, "Mallinckrodt had asked for the temporary injunction as it appeals a lower court ruling that allowed CMS to reset the base date average manufacturer price, or AMP. The Appeals Court also ordered an expedited briefing and oral argument schedule that will likely lead to fall oral arguments, and potentially a ruling by end of year. As a result of today's appeals court ruling, Mallinckrodt will change the base date AMP for Acthar Gel, as directed by CMS. The effect of the change is an immediate recognition of retroactive non-recurring charges (estimated at approximately $650 million through mid-June) and the prospective loss of Acthar Medicaid net sales, which has historically contributed to Acthar Gel net sales of $90 to $100 million annually. The company will continue to appeal the March 16 ruling by the U.S. District Court for the District of Columbia that upheld CMS' position. Barring other arrangements, the cash payments for retroactive Medicaid rebate charges will be processed over time, in accordance with the normal rebate payment schedule, and the company expects the cash outlays will most likely commence in the fourth quarter of 2020. Despite the ruling, Mallinckrodt remains committed to ensuring that Medicaid patients have access to Acthar Gel." Mallinckrodt Chief Legal Officer Mark Casey said, "We are disappointed in the appeals court decision not to issue a temporary injunction to prevent CMS from enforcing this change in Medicaid rebate calculations while our case is still under appeal. We will continue our appeal, which could be decided as early as end of year, and strongly believe that the District Court misinterpreted the statute that governs the Medicaid drug rebate program and failed to hold CMS accountable to the Administrative Procedure Act. CMS twice confirmed in writing its approval of the Acthar Gel Medicaid rebate calculation in use today, before it later reversed its position without giving fair notice or any clear legal basis for doing so."

10:45 EDT Mack-Cali Realty names MaryAnne Gilmartin board chair - Mack-Cali Realty Corporation announced that MaryAnne Gilmartin has been elected Chair of the Board of Directors, effective immediately. Mack-Cali has also completed the previously announced reconstitution of its Board. In addition to Gilmartin, the reconstituted Board is comprised of Alan R. Batkin, Michael Berman, Frederic Cumenal, Tammy K. Jones, A. Akiva Katz, Nori Gerardo Lietz, Mahbod Nia, and Howard Stern. Gilmartin said, "The newly reconstituted Board is determined to put Mack-Cali on the right path to restoring strong corporate governance practices and shareholder value. We look forward to driving meaningful transformation at the company to benefit all of our stakeholders."

10:03 EDT Dunkin' Brands, Uber expand relationship to 1,000 additional restaurants - Dunkin' (DNKN) announced that it's expanding its relationship with Uber Eats (UBER) to 1,000 additional restaurants across the country this month after seeing success with the service that launched in May. With this expansion, there will be up to 5,000 total Dunkin' locations nationwide offering delivery through Uber Eats by the end of June, giving more guests the chance to have their favorite Dunkin' menu items delivered directly to their doorstep. To celebrate the start of summer and this expansion, Uber Eats is offering a special buy one, get one free offer on small Dunkin' Iced Coffees now through June 21. Guests can also take advantage of a $0 delivery fee on Dunkin' orders of $10 or more through Uber Eats beginning June 24, while supplies last.

10:00 EDT RYB Education falls -13.6% - RYB Education is down -13.6%, or -48c to $3.07.

10:00 EDT Credit Suisse FI Large Cap Growth Enhanced ETN falls -26.9% - Credit Suisse FI Large Cap Growth Enhanced ETN is down -26.9%, or -$90.23 to $244.72.

10:00 EDT 58.com rises 10.2% - 58.com is up 10.2%, or $5.09 to $54.91.

09:55 EDT Antero Resources trading resumes

09:47 EDT Hovnanian falls -10.6% - Hovnanian is down -10.6%, or -$2.21 to $18.73.

09:47 EDT Small Cap Bear 3x rises 8.6% - Small Cap Bear 3x is up 8.6%, or $2.10 to $26.48.

09:47 EDT ProShares Trust Ultra VIX Short Term Futures ETF rises 12.7% - ProShares Trust Ultra VIX Short Term Futures ETF is up 12.7%, or $5.15 to $45.61.

09:40 EDT Antero Resources announces $402M overriding royalty transaction - Antero Resources announced the closing of an overriding royalty interest, or "ORRI," transaction with Sixth Street Partners that will result in proceeds to the company of up to $402M. Proceeds will be used to repay revolver borrowings and the effective date of the transaction is April 1, 2020. Further, the company announced that it is has repurchased additional 2021 senior notes during the second quarter and that $540M of that issue remain outstanding. Pro forma for the initial proceeds from the ORRI transaction and the repurchase of senior notes during the quarter, the company has approximately $745M drawn on its revolving credit facility and $1.2B in liquidity under its credit facility as of March 31, Antero stated. Paul Rady, Chairman and CEO of Antero, commented, "The ORRI transaction addresses over half of our $650 to $900 million asset sale goal for 2020 and allows us to pay down debt, while importantly retaining the long-term upside of our core acreage position. Additional asset sales and projected free cash flow during 2020 will be used to further reduce debt."

09:27 EDT Diana Shipping announces time charter contract for m/v Maera - Diana Shipping announced that, through a separate wholly-owned subsidiary, it has entered into a time charter contract with Ausca Shipping Limited, Hong Kong, for one of its Panamax dry bulk vessels, the m/v Maera. The gross charter rate is $8,600 per day, minus a 5% commission paid to third parties, for a period until minimum July 1, 2021 up to maximum September 30, 2021. The charter commenced on June 11, 2020. The "Maera" is a 75,403 dwt Panamax dry bulk vessel built in 2013. This employment is anticipated to generate approximately $3.27 million of gross revenue for the minimum scheduled period of the time charter.

09:23 EDT Opes Acquisition says target BurgerFi boosts national expansion - Opes Acquisition Corp's business combination target, BurgerFi International launched its first "ghost kitchen" in Miami, FL today. The burger chain announced last month a multi-market licensing agreement with REEF Kitchens. The VC-backed "neighborhood kitchen" is the first of up to 15 planned kitchens for BurgerFi across the country. This newly opened Miami locale will service all of Downtown Miami and the Brickell area. BurgerFi has two more Miami delivery-only, "ghost" kitchen locations in the pipeline with the next one set to open in Midtown Miami shortly thereafter, increasing the brand's reach from the Midtown area to Wynwood and the Design District.

09:14 EDT MannKind presents original analyses of Afrezza clinical data - MannKind announced that new data from clinical studies of Afrezza Inhalation Powder was presented at the American Diabetes Association's 80th Scientific Sessions, June 12-16, 2020. The data presented includes: A comprehensive post hoc analysis of four unique studies assessing the safe and effective dosing of Afrezza in patients with type 1 diabetes. An analysis demonstrating treatment with Afrezza is associated with weight loss in patients with type 2 diabetes, compared to weight gain with injected mealtime insulin. An evaluation of a comprehensive two year safety study showing that significant changes in FEV1 during treatment with Afrezza are both uncommon and generally transient in nature. Poster 1023: Dose Titration and Clinical Effects of Inhaled Technosphere Insulin Compared with Mealtime Subcutaneous Analog Insulin Therapy in Type 1 Diabetes: Ultra rapid-acting Afrezza can be safely and effectively dosed at 1.5 to 2.0 times that of injected mealtime insulin. This dosing ratio appears to be consistent across a range of A1C responses. Afrezza's ultra rapid-acting profile may supersede the perceived precision of injected mealtime insulin dosing and provides patients the ability to flexibly dose based on glycemic response. Poster 1024: Technosphere Insulin Added to Basal Insulin Is Associated with Less Weight Gain than Basal Insulin plus Insulin Aspart or Insulin Analog 70/30 Mixture in Type 2 DM: Patients with type 2 diabetes treated with Afrezza showed modest weight loss while those treated with insulin aspart or insulin aspart mix resulted in weight gain. The weight difference estimate between Afrezza and insulin aspart was 1.83 pounds. The weight difference estimate between Afrezza and biaspart insulin was 3.17 pounds. The effect on body weight was independent of the magnitude of improvement in glucose control. Oral Abstract 235: Incidence of Significant Changes in Pulmonary Function during A 2-year Study with Inhaled Technosphere Insulin: Prior clinical studies have shown a modest difference in mean change in FEV1 over two years when comparing treatment with Afrezza to other diabetes therapies. The majority of individuals treated with Afrezza had no significant change in FEV1 measured at any time. Overall, 98% of patients on Afrezza had either no significant change or were observed to have only a transient change in FEV1 over the two years of study.

09:10 EDT American BriVision completes patient enrollment in trial for adult ADHD - American BriVision announced the completion of patient enrollment of ABV-1505 Phase II Part I clinical trial for the treatment of adult attention-deficit hyperactivity disorder. The new study will be conducted at the University of California San Francisco Medical Center. The company said that ABV-1505, with the active pharmaceutical ingredient PDC-1421, has been successfully evaluated in a recently completed Phase II study conducted at Stanford University and five major medical centers in Taiwan for the treatment of major depressive disorder. This current trial is an open label, single-center, dose escalation study designed for the enrollment of six adult ADHD patients. Each patient will receive a low-dose treatment thrice daily for 28 days followed by a high-dose treatment thrice daily for another 28 days. The primary objective of this study is to determine the effective doses and treatment period of ABV-1505 in adult patients with ADHD. The secondary objective is to evaluate the safety of ABV-1505 in patients receiving the drug at various dose levels. A Phase II Part II study is expected to follow at the UCSF Medical Center, along with major medical centers in Taiwan, after and assuming successful completion of this Phase II Part I study.

09:09 EDT Golub Capital BDC announces purchases of common stock by affiliates, others - Golub Capital announced that certain affiliates of Golub Capital LLC, an affiliate of GC Advisors LLC, the company's investment adviser, and a trust that acquires shares of company common stock for the purpose of awarding incentive compensation to employees of Golub Capital LLC, acquired over 5.6M shares of the company's common stock between April 1 and June 15. The company previously disclosed that these entities held an aggregate of more than 12M shares of the company's common stock as of March 31.

09:07 EDT REV Group CFO Dean Nolden steps down, Mark Skonieczny succeeds - REV Group (REVG) announced that Dean Nolden is stepping down as CFO. Replacing Nolden, the company appointed Mark Skonieczny CFO effective immediately. Skonieczny was most recently VP and corporate controller of Adient (ADNT). As CFO, Skonieczny will lead REV Group's financial organization and be responsible for accounting, treasury, financial planning and analysis, tax, corporate development and investor relations.

09:04 EDT Wins Finance request for extended stay of suspension granted by Nasdaq - Wins Finance announced that it has been granted an extended stay as to the suspension of the company's ordinary shares from trading on the Nasdaq Capital Market pending the company's scheduled hearing before the Nasdaq Hearings Panel on July 2 and the issuance of a final Panel decision.

09:04 EDT Brown-Forman to sell Early Times, Canadian Mist, Collingwood to Sazerac Company - Brown-Forman announced hat it has reached an agreement to sell the Early Times, Canadian Mist, and Collingwood brands, and the Canadian Mist production assets, to Sazerac Company. Brown-Forman said in a release, "This sale reflects the continued evolution of the company's portfolio strategy to focus on premium brands. Brown-Forman has actively managed the shape and contents of its portfolio over the last decade and a half through developing, acquiring, and divesting various businesses and brands. The company believes this portfolio management, alongside innovation, will allow it to continue to focus on the best growth prospects and value creation over the long term. The sale of these brands is expected to close later this summer."

09:02 EDT Honeywell forms new business unit - Honeywell has formed a new business unit dedicated to the growing Unmanned Aerial Systems and Urban Air Mobility industries. The Unmanned Aerial Systems business unit will continue Honeywell's momentum and leadership in these emerging markets, utilizing Honeywell's technology, software, services and certification expertise to meet customers' needs in these markets. Equipped with its own engineering and sales resources, the UAS business unit will develop new products and services uniquely required for these markets.

09:00 EDT Net Element trading resumes

08:49 EDT Rezolute announces publication of RZ402 data in DME - Rezolute announced that the company's abstract accepted to the virtual Association for Research in Vision and Ophthalmology 2020 meeting, titled "Nonclinical safety and pharmacology of RZ402, a plasma kallikrein inhibitor, for the treatment of diabetic macular edema as a daily oral therapy," was published in the peer-reviewed journal Investigative Ophthalmology & Visual Science. Highlighted results of RZ402 single and repeat oral dosing studies in rats and cynomolgus monkeys include the following: RZ402 demonstrated an excellent ADME profile, with moderate renal clearance; Plasma levels of RZ402 remained above EC50 for 24 hours after dosing, consistent with a daily oral dose regimen; No adverse effects were seen in rat models after repeat-dose administration at over 500-fold excess dosing for 7 days; No adverse effects were seen in respiratory or central nervous system safety pharmacology studies in rats or in cardiovascular safety studies in monkeys; Dose-proportional exposure up to 800 mg/kg in monkeys.

08:48 EDT Wyndham Hotels & Resorts to open five new Ramada Hotels in China - Wyndham Hotels & Resorts announced plans for further growth in China as travel in the country continues to show encouraging signs of recovery. The company will add five new hotels to its Ramada by Wyndham brand this quarter, with three of the hotels already open: the 142-room Ramada by Wyndham Luoyang Downtown, the 191-room Ramada by Wyndham Jianyang and the 140-room Ramada by Changsha Wuguang. Joining them later this month will be the 101-room Ramada by Wyndham Wuhan Qingshan and 179-room Ramada by Wyndham Kunming Yiliang.

08:47 EDT ManTech appoints Matt Tait as COO - ManTech announced the appointment of Matt Tait as COO effective July 1, 2020, a new role in which he will report directly to Kevin Phillips, ManTech's President and CEO. In addition, the company is implementing an important organizational change that will realign the two current business groups - Mission Solutions & Services and Mission, Cyber & Intelligence Solutions - and create three business sectors: Intelligence, Defense and Federal Civilian. These organizational changes will enhance ManTech's ability to leverage its broad and differentiated capabilities to better serve its customers' emerging and sophisticated needs. Tait joined ManTech in July 2018 as President of the company's MSS Group, and in that role has been responsible for delivering a broad range of engineering, technology and digital services that enable the success of our customers' national security and federal civilian missions. Under the realignment, ManTech's SVPs and General Managers Adam Rudo, Andrew Twomey and Bryce Pippert will directly report to the COO and be appointed as Executive Vice Presidents and General Managers of the Intelligence, Defense and Federal Civilian Sectors, respectively. Twomey and Pippert currently oversee ManTech's defense and federal civilian businesses. Rudo oversees ManTech's Security Solutions business unit. The changes announced today are not expected to have a material impact on the company's 2020 financial results or guidance as updated in April.

08:45 EDT Delta 9 enters Newfoundland and Labrador Market, acquires Oceanic shares - DELTA 9 CANNABIS announced that it has entered into a definitive agreement with Oceanic Releaf and Ms. Taylor Giovannini and to acquire a five percent interest in the common stock of Oceanic in exchange for the provision by Delta 9 of certain consulting and training services to Oceanic. Delta 9 has also entered into an agreement with the Province of Newfoundland and Labrador, Newfoundland and Labrador Liquor Corporation and Oceanic pursuant to which Delta 9 will supply cannabis and cannabis-related products in that Province. Consideration for the common shares acquired by Delta 9 in the capital stock of Oceanic will be paid by way of the provision of certain consulting and training services to Oceanic over a term of one year pursuant to a strategic cooperation agreement. The intent of the strategic cooperation agreement is to further Oceanic's efforts to establish itself as a licensed cannabis producer in Newfoundland and Labrador.

08:43 EDT Kinross Gold reaches terms with Government of Mauritania - Kinross Gold Corporation announced that it has reached an agreement in principle with the Government of Mauritania to enhance the parties' partnership. The key terms of the agreement, which remain subject to definitive documentation, are the culmination of discussions between Kinross and the Government that balance the interests of both parties. The terms contemplate reasonable commercial trade-offs intended to provide certainty and resolution of outstanding matters. Under the terms of the agreement, the Government will provide Kinross with a 30-year exploitation license for Tasiast Sud under the 2008 Mining Code and the 2012 Mining Convention, granted with expedited permitting and the possibility of early mining. The agreement also provides for the reinstatement of the tax exemption on fuel duties1 and the repayment by the Government to Kinross of approximately $40 million in outstanding VAT refunds with an agreed payment schedule through 2025. Kinross will make a $10 million payment to the Government after completion of the definitive agreements to resolve disputed matters related to fuel use and tax exemptions. In addition, upon receiving the exploitation license for Tasiast Sud, Kinross will make a $15 million payment to resolve disputed matters arising out of Kinross' prior application to convert the Tasiast Sud exploration license into an exploitation license. At Tasiast, Kinross has also volunteered to update its existing fixed 3% royalty payable under the 2006 Tasiast Mining Convention. While the 2006 Convention remains in full force and effect for Tasiast, the mining laws of Mauritania have evolved in a manner that is consistent with other African mining jurisdictions. Accordingly, Kinross decided it was appropriate to pay an escalating royalty tied to the price of gold1 that aligns with the 2008 Mining Code and the 2012 Mining Convention, and is comparable with other royalties in the region. A renewed partnership approach for Tasiast Sud contemplates the Government receiving a 15% free carried interest in Tasiast Sud with an option to purchase an additional 10% participating interest in the project after additional feasibility work is completed. The parties have also agreed to enhanced exploration programs at Tasiast Sud and Kinross-held concessions north of the current mining area, to the extent achievable in the current COVID-19 environment. The exploration program at the large, underexplored and prospective Tasiast Sud property is expected to focus on upgrading existing indicated resource estimates of 193 Au koz.2 and inferred resource estimates of 817 Au koz2 and to potentially enhance the probable reserve estimates of 144 Au koz. The Government will have the right to nominate two observers to the Board of Directors of the Kinross subsidiary operating the Tasiast mine and will also have a right to nominate one representative and one observer to the Board of the Kinross subsidiary that will operate Tasiast Sud.

08:42 EDT Wrap Technologies announces BolaWrap purchase by third EU country - Wrap Technologies announced a new opening order of BolaWrap products and accessories. Wrap Technologies said in a release, "This European order represents the third major country in Europe to order BolaWrap products in the last eight months. The company has 15 international distributors covering 28 countries, export licenses in 54 countries, and has delivered product to 26 countries thus far. One of the three European countries to recently purchase BolaWrap is Spain. In late February, the Company participated at the SICUR International Security, Safety and Fire Exhibition, Spain's leading international security event in Madrid. The exhibition led to strong interest for the BolaWrap by the region's law enforcement community. Although Spain was largely shut down for COVID-19 during recent months, the Company staged numerous online webinar demonstrations for police agencies. Once Spain began to reopen towards the end of May, the Company's distributors resumed in-person demonstrations to police agencies across Spain, covered nationally by ABC Espana."

08:40 EDT Kemet, Yageo complete merger - KEMET Corporation announced the completion of the acquisition of KEMET by Yageo Corporation. In accordance with the terms of the merger agreement, Yageo has acquired all of the outstanding shares of KEMET's common stock for US $27.20 per share in an all-cash transaction with an equity value of approximately $1.6B. As a result of the transaction, KEMET is now a wholly-owned subsidiary of Yageo, and KEMET's common stock is no longer listed on any public market.

08:39 EDT Beyond Air enrolls first patient in U.S. study of nitric oxide therapy - Beyond Air announced the first patient has been enrolled in the U.S. clinical study using the LungFit system to treat COVID-19 with NO therapy. The patient was enrolled at the Baptist Health Center for Clinical Research in Little Rock, Arkansas. The US trial is an open-label study of 20 adult patients hospitalized with COVID-19. Subjects will be randomized 1:1 and treated intermittently with 80 ppm NO administered over 40 minutes, 4 times per day, in addition to standard supportive therapy or treated with SST alone. The primary endpoint is time to clinical deterioration as measured by the need for: non-invasive ventilation: or high flow nasal cannula; or intubation. Other endpoints include reduction in viral load, need for supplemental oxygen, hospital length of stay, mortality, safety and various biomarkers.

08:38 EDT PDS Biotechnology initiates Phase 2 trial of PDS0101 - PDS Biotechnology Corporation announced that the first patient has been dosed in the National Cancer Institute's Phase 2 clinical study of PDS0101 in the treatment of advanced human papillomavirus associated cancers. This clinical trial involves a combination of PDS0101 with two clinical development-stage immune-modulating agents, Bintrafusp alfa and NHS-IL12. The NCI Center for Cancer Research's Genitourinary Malignancies Branch and Laboratory of Tumor Immunology and Biology are jointly leading this Phase 2 trial evaluating PDS0101, which combines the Versamuneplatform with targeted antigens in HPV-expressing cancers, in combination with Bintrafusp alfa and NHS-IL12. The trial will evaluate the objective response rate of this novel triple combination in approximately 35 patients with advanced HPV-associated cancers. The first eight patients will be evaluated for safety and objective response before the trial progresses to full enrollment.

08:36 EDT Phathom randomizes first new patients in Phase 3 trials following pause - Phathom Pharmaceuticals announced that it has randomized the first new patients in each of its two Phase 3 clinical trials since temporarily pausing new patient randomization in response to the COVID-19 pandemic. In March, Phathom temporarily paused new patient randomization in its PHALCON-EE and PHALCON-HP clinical trials. The decision was not based on any study-related COVID-19 infections or other safety events but rather was in support of global efforts to combat the spread of the SARS-CoV-2 coronavirus. During the temporary pause, Phathom worked closely with sites to ensure patients who were already enrolled and randomized in the PHALCON-EE and PHALCON-HP studies could remain safely in the trial with as little disruption as possible. Phathom has not experienced any interruptions to clinical trial supply, including manufacturing and the overall supply chain. Phathom continues to closely monitor the COVID-19 situation and, at this time, continues to expect to provide top-line data from the PHALCON-EE and PHALCON-HP trials in 2021.

08:35 EDT United Airlines expects to have about $17B in available liquidity by September - United Airlines announced that it expects to have total available liquidity of approximately $17B at the end of the third quarter. This dollar amount reflects committed financing of $5B to be secured by the airline's loyalty program, MileagePlus, that allows the airline to continue to operate, evolve, and grow the program, as well as $4.5B expected to be available to United through the Coronavirus Aid, Relief, and Economic Security Act Loan Program. The company believes it has sufficient slots, gates and routes collateral available to meet the collateral coverage that may be required for the full $4.5B available to the company under the Loan Program. This $9.5B of additional liquidity will provide even more flexibility as the airline navigates the most disruptive financial crisis in the history of aviation. Given the impact COVID-19 has had on travel demand, United has spent the past several months aggressively and proactively cutting costs. The airline has already reduced planned capital expenditures and operating and vendor expenditures, suspended raises and implemented an unpaid time off program for management and administrative employees, put a freeze on hiring, introduced voluntary leave and separation programs, reduced pay for all executives and cut its CEO and President's base salaries by 100%, among other cost-saving measures. United expects an average cash burn of approximately $40M per day in the second quarter and to reduce its average cash burn to approximately $30M per day in the third quarter. Goldman Sachs Lending Partners, Barclays Bank PLC and Morgan Stanley Senior Funding have committed to provide, and have agreed to arrange the syndication of, the MileagePlus financing through a term loan facility, which is expected to close, subject to standard conditions precedent, by the end of July. Goldman Sachs Lending Partners will act as the sole structuring agent and lead left arranger for the transaction.

08:34 EDT Genius Brands jumps 14% to $4.75 after Arnold Schwarzenegger investment

08:33 EDT Seelos Therapeutics to host KOL on Phase 1 data, trial design for SLS-002 - Seelos Therapeutics announced that it will host a key opinion leader call to provide updates regarding data from the Phase I study of SLS-002 on Tuesday, June 23, 2020 at 1:00 p.m. Eastern Time. Seelos will also provide an overview of the design for Seelos' next study of SLS-002 for Acute Suicidal Ideation and Behavior in patients with Major Depressive Disorder during the call. The call will feature a discussion with Michael E. Thase, MD, professor of psychiatry at the University of Pittsburgh Medical Center and the Western Psychiatric Institute and Clinic. Dr. Thase is an active clinical investigator whose research focuses on mood disorders and will be available to answer questions at the conclusion of this call.

08:31 EDT MJardin says well-positioned for entry in Canada recreational market in 2H20 - The company said, "Management remains focused on drawing from its 10+ years of experience commercially growing cannabis at scale in order to maximize production from the Company's existing portfolio of assets. MJardin is confident that our cultivation expertise and core-competency of high THC high yielding flower will position the company well for an entry into the recreational market in Canada during the second half of 2020. "WILL" - Cultivation Facility in Brampton, Ontario: Construction has been completed on this facility and 10 of the 12 flower rooms have now been licensed by Health Canada. The Company expects to receive licenses for the remaining two flower rooms imminently. This expansion is expected to result in run-rate production of 3,000 KG per year at the WILL facility during the third quarter of 2020. "AMI" - Cultivation Facility in Lower Sackville, Nova Scotia: Phase 1 of the facility operated through a three-way joint-venture between the Nova Scotia Mi'kmaq First Nations, MJardin and the Halef Group is fully operational with a run rate production of 3,500 KG per year. During 2019, construction was completed on the Phase 2 expansion, bringing on an additional 2,800 KG per year of capacity with licensing and run rate production expected by the fourth quarter of 2020. Additionally, AMI continues to work towards EU GMP certification of the facility and anticipates full certification by the end of the fourth quarter of 2020. "GRO" - Cultivation Facility in Dunnville, Ontario: The joint-venture between MJardin and Grand River Organics is now fully licensed, with the first harvest from the facility already completed in the second quarter of 2020. The Company anticipates full run-rate production of 1,200 KG annually by the third quarter of 2020. "WARMAN" - Cultivation Facility in Winnipeg, Manitoba: A cultivation and processing license was granted to GrowForce Manitoba during the fourth quarter of 2019. The joint venture between MJardin and Peguis First Nation is on track for completion during 2020 along with Phase 2 facility construction. The Warman facility is expected to begin production in the second quarter of 2021. US Owned Operations: Following the completion of the sale of the Cheyenne facility and the termination of the Cannabella acquisition, the Company's US footprint has diminished from the beginning of 2019. However, management views the United States as a desirable growth market and will continue to pursue strategic joint ventures, acquisitions or consulting arrangements in select States on a case-by-case basis."

08:27 EDT Agraflora Organics' Delta greenhouse commences cultivation - AgraFlora Organics announced that Propagation Services Canada Inc., the Company's flagship cultivation asset located in Delta, British Columbia has commenced commercial cannabis cultivation. PSC has commenced cultivation using a curated portfolio of live-plant genetics with a focus on producing high potency cannabis with attractive strains, while maintaining a low cost. Management anticipates the combination of high potency and low cost will result in a product that is attractive to consumers in the retail and wholesale markets. Management expects PSC to commence sales during 2020. The first phase of operations at the Delta Facility utilizes 422,828 sq. ft. of cultivation space with state-of-the-art semi-pressurized, semi-open Venlo greenhouses. The Delta Facility is located in a desirable agricultural micro-climate on the Pacific coast which will contribute to increased quality and reduces the cost of cooling the Delta Facility. Management expects these attributes, along with the Elite Genetics, to produce a compelling value proposition for customers by providing high potency cannabis at a fair price.

08:26 EDT Ziopharm appoints Carl June as chairman of Scientific Advisory Board - Ziopharm Oncology announced the appointment of Carl June, M.D., as Chairman of its newly formed Scientific Advisory Board. Dr. June is recognized in the oncology field for his groundbreaking work in the development and commercialization of gene therapy and T-cell therapies. The SAB will provide strategic counsel to guide the efficient development of Ziopharm's innovative technologies and pipeline of immunotherapies to treat the many patients with solid tumors. June has published more than 500 manuscripts on immunotherapy. He currently serves as the Richard W. Vague Professor in immunotherapy in the Department of Pathology and Laboratory Medicine and as the Director of the Center for Cellular Immunotherapies at the Perelman School of Medicine, as well as the Director of the Parker Institute for Cancer Immunotherapy at the University of Pennsylvania.

08:23 EDT Nano Dimension gains RoHS 3 certification - Nano Dimension announced that it has successfully achieved the RoHS 3 certification. The certification confirms that the dielectric and conductive inks used by the DragonFly LDM System for additive manufacturing of electronics are recyclable as well as non-hazardous and non-polluting. In addition, it assures that the waste created in the printing process may be recycled or disposed without any restrictions.

08:23 EDT CanWel Building Materials announces no change to Q2 dividend - There is no change to the second quarter 2020 dividend. CanWel is pleased to announce that its Board of Directors has declared a quarterly dividend of C$0.14 per common share, for the 33rd consecutive quarter, which will be paid on July 15, 2020, to shareholders of record on June 30, 2020. While the business continues to perform well, the Board is sensitive to the current environment, and accordingly, the Board of Directors has adjusted the Company's quarterly common share dividend from C$0.14 to C$0.12 per share, effective for the dividend declared in the third quarter of 2020, which is expected to be paid on October 15, 2020, to shareholders of record on September 30, 2020.

08:22 EDT CanWel Building Materials says January-May sales increase 8% y/y - The company said, "Subsequent to reporting Q1 2020 financial results, CanWel has experienced continued resilience across its business segments with steady end-market demand resulting in an 8% increase in year-to-date sales when compared to the same period in 2019. The Company is also benefitting as the economy starts to re-open in certain jurisdictions that had previously restricted activity. The Company's treated wood business has particularly shown strong performance during the period due to the positive impact from increased demand and volumes coming from consumers spending more time and efforts on home renovation and repair projects. This "stay at home" and "do it yourself" renovation and repair market has been extremely robust during the second quarter and we continue to see this trend in early June. The ultimate impact of the COVID-19 pandemic on the Company's second quarter and full-year 2020 results is difficult to quantify as it will depend on the duration of the pandemic, the impact of government policies, and the pace of economic recovery. The Company remains confident that its business model, cash flow profile, and liquidity will be more than sufficient to address a varied range of COVID-19 scenarios that may occur in 2020. The Company will continue to firmly manage the business in the short term and make continued progress with respect to its long-term growth strategies."

08:20 EDT Net Element trading halted, news pending

08:18 EDT Beyond Air announces publication of peer-reviewed journal article - Beyond Air announced the publication of its scientific article, "Inhaled nitric oxide therapy in acute bronchiolitis: A multicenter randomized clinical trial" in Scientific Reports, an online peer-reviewed journal from the publishers of Nature.

08:16 EDT FDA approves JUVEDERM VOLUMA XC for enhancement of chin region - Allergan Aesthetics, an AbbVie company, announced the FDA approval of JUVEDERM VOLUMA XC for the augmentation of the chin region to improve the chin profile in adults over the age of 21. As the category leader, the JUVEDERM Collection of Fillers has the broadest portfolio of specifically tailored treatment options, and this latest approval marks their fifth approved indication in the U.S.

08:14 EDT AIM ImmunoTech: Ampligen receives commercial approval in Argentina for ME/CFS - AIM ImmunoTech provided an update on the commercial launch of Ampligen for the treatment of severe Chronic Fatigue Syndrome, or CFS, in Argentina. AIM ImmunoTech said in a release, "Ampligen, the first drug ever to receive commercial approval in any country as a treatment for severe ME/CFS, has achieved its next important regulatory step having received import clearance from Argentina's Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica, or ANMAT, Argentina's equivalent to the FDA, to import the first shipment of commercial grade vials of Ampligen to Argentina. This follows the earlier clearance from the FDA to export Ampligen to Argentina for commercial sale. The next steps in the commercial launch of Ampligen include ANMAT conducting a final inspection of the product and release tests before granting final approval to begin commercial sales. Once final approval by ANMAT is obtained, GP Pharma will begin distributing Ampligen in Argentina. The FDA requires certain regulations be met with a U.S. manufactured drug not yet approved for commercial use by the FDA, before export to a foreign country after that country's commercial approval. In order to receive clearance to export to Argentina, AIM ImmunoTech submitted information on the drug approval processes and standards in Argentina, as well as the issuance by ANMAT of its approval of Ampligen. The FDA determined on September 19, 2019 that the processes and standards applicable to drug approval in Argentina meet the requirements under section 802(b)(2) of the U.S. Federal Food, Drug and Cosmetic Act. Those requirements include expert review of safety and effectiveness, good manufacturing practice and quality controls, adverse experience reporting and control of drug labeling and promotion. To the Company's knowledge, this is the first time in over ten years, and only the second time ever, the FDA has made this determination."

08:13 EDT CAI International CEO Victor Garcia submits resignation - CAI announced a change in leadership. Timothy Page, the company's CFO, was appointed executive VP and interim president and CEO to succeed Victor Garcia. Garcia submitted his resignation as a member of the company's Board, and Page was subsequently appointed by the board to fill the vacated seat until the next annual meeting, at which time the board has recommended to the shareholders that Page be elected to the board. The company is in the process of an active search for a permanent CEO.

08:10 EDT Motus GI Holdings launches mobile app for on-demand support - Motus GI Holdings announced that physicians and hospitals using the Pure-Vu System will now have on-demand access to a full spectrum of Motus support and educational resources via the new Motus GI mobile app, which was launched today. This new mobile solution is a part of a larger effort to diversify and digitize much of the go-to-market content for the Pure-Vu System, which is being adopted by a growing number of major U.S. hospitals since being commercially launched at the end of 2019. This new mobile interface provides Pure-Vu System users instant access to on-demand video support and training resources, including demo and intra-procedural videos, live set-up tutorials, and case studies. The app can be customized to individual hospitals, enabling the administration and healthcare teams to share and track protocols and upload external materials specific to their respective endoscopy department. It is available to all Pure-Vu System users via the 'imsmart' umbrella in the App store. The Pure-Vu System is designed to improve visualization of the colon, enabling gastroenterologists to perform a quality colonoscopy. The system is cleared for use by the U.S. Food and Drug Administration to help facilitate the cleaning of a poorly prepared colon during the colonoscopy procedure. The system integrates with standard and slim colonoscopes to improve visualization during a colonoscopy, while preserving established procedural workflow by irrigating the colon and evacuating debris to provide a better-quality exam. Challenges with bowel preparation for inpatient colonoscopy, particularly patients who are elderly, with comorbidities, or active bleeds, represent a significant area of unmet need that directly affects clinical outcomes and increases the cost of care. Motus GI believes the Pure-Vu System may lead to positive outcomes and lower costs for hospitals by safely and quickly improving visualization of the colon for a quality exam. In multiple clinical studies to date, involving the treatment of challenging inpatient and outpatient cases, the Pure-Vu System has consistently helped achieve adequate bowel cleanliness rates greater than 95% following a reduced prep regimen. Motus GI estimates that approximately four million inpatient colonoscopy procedures take place worldwide each year.

08:09 EDT Gold Resource acquires golden mile property in Nevada Walker Lane belt - Gold Resource Corporation announced the acquisition of the Golden Mile property located in the Bell Mining District, Mineral County, Nevada. The 9,334 acre property contains surface and near surface high-grade gold in two established mineralized zones. Historic third-party drill intercepts from Golden Mile include: 10.70 meters of 8.76 grams per tonne gold from surface, 36.60 meters of 10.26 g/t gold from 15.20 meters downhole, and 6.10 meters of 46.53 g/t gold from 18.29 meters downhole. Golden Mile is an advanced exploration property with district-size potential for expansion of known mineralized zones and new discoveries. The property also adds considerably to the Company's prospective exploration land package by more than 51%. This fifth high-grade property solidifies the Company's Nevada Mining Unit as controlling a dominant land position in this region of the Walker Lane Mineral Belt. Gold Resource Corporation is a gold and silver producer, developer and explorer with operations in Oaxaca, Mexico and Nevada, USA. The Company has returned $114M 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 acquired 100% interest in the Golden Mile property from two separate business entities for total consideration of $650,000, consisting of $550,000 cash and $100,000 of Gold Resource Corporation shares. The sellers retained a net smelter return royalty of 3% on future production from the property claims. The Company has the right to buy down 1% of the NSR on the claims for $1,500,000.The Golden Mile property covers an area of 9,334 acres consisting of 451 unpatented lode mining claims and 5 patented mining claims in central Nevada's Walker Lane Mineral Belt in Mineral county, Nevada. Two established mineralized zones have been drilled by previous operators on the property with the larger mineralized zone located within the 5 patented claims. The property is located approximately 23 miles east-southeast of the Company's producing Isabella Pearl mine and becomes the fifth property in the Company's Nevada Mining Unit. Gold Resource Corporation's Nevada Mining Unit now controls approximately 27,600 acres of highly prospective exploration land in south central Nevada's Walker Lane Mineral Belt. Mineralization at Golden Mile is intrusion related gold-copper exo- and endoskarn associated with massive replacements of carbonate rocks and shear hosted gold. Historical 1930's production records show gold along with minor copper and silver being produced from small open pits and shallow underground workings. The Golden Mile property met the Company's acquisition criteria for numerous reasons including: high-grade gold drill results, low-cost open pit heap leach project potential, proximity to the Company's producing Isabella Pearl gold mine for operational synergies, large land package containing two advanced exploration target zones of gold mineralization, numerous additional exploration targets, preliminary metallurgical test work indicating cyanide leachability, 100% ownership and significantly strengthens the Company's Nevada Mining Unit land position. Management plans to secure exploration drill permits and commence follow-up drill programs in the near future focusing on the two established mineralized zones, the Golden Mile zone and PS-SP zone, with the goal to delineate both into mineable open pit heap leach deposits. While the district-size potential has numerous exploration targets, at this point management will focus on the known mineralized zones with high probability resource delineation based on the past third-party drill results and historic preliminary resource estimates. With successful follow-up and delineation drilling, Golden Mile could become one of the next mines to be developed from the Nevada Mining Unit after the Isabella Pearl mine. During due diligence, the Company also commissioned preliminary metallurgical test work which included cyanide bottle-roll tests yielding results of 82% gold recovery, demonstrating that gold mineralization is amenable to cyanide leaching.

08:08 EDT Moderna appoints Ray Jordan as Chief Corporate Affairs Officer - Moderna (MRNA) announced that Ray Jordan has joined Moderna as Chief Corporate Affairs Officer, effective Monday, June 15. He will serve on Moderna's Executive Committee and report to CEO Stephane Bancel. Jordan served as Senior Vice President, Corporate Affairs at Amgen (AMGN) from 2012 through 2019.

08:07 EDT Finnair, Sabre renew distribution agreement - Finnair and Sabre announced a new worldwide distribution partnership. Under the new agreement, Sabre will resume distributing competitive global Finnair content to hundreds of thousands of travel agents and thousands of corporations worldwide through its travel marketplace.

08:05 EDT Century Casinos reopens all five casinos in Alberta, Canada - Century Casinos announced that operations at Century Casino & Hotel Edmonton, Century Casino St. Albert, Century Mile Racetrack and Casino, Century Downs Racetrack and Casino as well as Century Casino Calgary resumed on June 13, 2020. Live racing at the company's two horse racetracks Century Mile and Century Downs will resume shortly. Prior to reopening, Century Casinos implemented comprehensive sanitizing and social distancing protocols based on Alberta Health Services guidelines and newly established industry standards at the properties. Details about these measures are available in the Covid-19 section of the properties' websites.

08:04 EDT Ardelyx reports 'positive' data from ongoing NORMALIZE study - Ardelyx reported positive data from its ongoing NORMALIZE study, which is designed to evaluate the ability of tenapanor, as monotherapy or in combination with sevelamer, to achieve serum phosphorus levels in the normal range in patients with chronic kidney disease on dialysis. Tenapanor is an investigational, first-in-class, phosphate absorption inhibitor which, if approved, will provide a completely new approach for the control of serum phosphorus in patients with CKD on dialysis, blocking the absorption of phosphorus at the primary pathway of uptake. "These data from the NORMALIZE study are unprecedented in terms of the proportion of patients able to achieve serum phosphorus levels less than 4.6mg/dL with foundational use of tenapanor," said Stuart Sprague DO, FASN, chief of the Division of Nephrology and Hypertension at Northshore University Health System. "This represents an important advancement in the management of hyperphosphatemia for patients on dialysis. The ability of tenapanor to drive phosphorus levels closer to normal has the potential to completely change the hyperphosphatemia treatment paradigm." The NORMALIZE extension study allowed patients from PHREEDOM, the positive Phase 3 long-term monotherapy study, to continue therapy with tenapanor, and enabled those in the safety control arm receiving sevelamer, to transition to tenapanor. The planned second analysis demonstrated that the foundational use of tenapanor as monotherapy or in combination with sevelamer carbonate produces a significant phosphorus-lowering effect with a mean serum phosphorous reduction of 2.33 mg/dL, from a mean baseline phosphorus of 7.27 mg/dL at the beginning of the PHREEDOM trial to a mean of 4.94 mg/dL at the time of this analysis. Of the 171 patients in this interim analysis who completed up to 9 months of treatment in this extension study, up to 47.4% achieved a normal serum phosphorus level, and of those, the majority were on tenapanor alone or tenapanor with low dose sevelamer of less than or equal to3 sevelamer tablets per day. These data represent a 58% improvement in the rate of patients who achieve a normal serum phosphorus level, as compared to current treatment practice data as reported in the April 2020 Dialysis Outcomes Practice Patterns Study Practice Monitor. The DOPPS data demonstrate that, with current standard of care treatment of phosphate binders alone, only 30% of patients have serum phosphorous levels less than 4.6 mg/dL. The only adverse event reported in greater than5% of patients in NORMALIZE was diarrhea, with an incidence rate of 23.3%.

08:03 EDT Navidea announces full enrollment in Phase 2b trial of Tc99m Tilmanocept - Navidea Biopharmaceuticals announced full enrollment in its ongoing NAV3-31 Phase 2B study titled "Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value on Tc99m Tilmanocept Planar Imaging". All of the subjects have been enrolled in the three-arm trial, and the study is on track for the last patient to be screened, and evaluated by end of 2020. The aim of this Phase 2B study is to evaluate the repeatability, reproducibility, and stability of Tc99m tilmanocept imaging in both healthy subjects and in patients with active RA, as well as to assess the ability of Tc99m tilmanocept to provide an early indicator of efficacy of anti-tumor necrosis factor alpha treatment in RA patients. The third arm mirrors Navidea's Phase 3 study, which has been designed to provide data to understand the magnitude of the signal change that could potentially occur as patients receive therapy. Navidea has enrolled 38 subjects in each Arm, and has concluded with another 29 subjects in Arm 3. Subjects in Arm 3 will be followed up to a period of 24 weeks with regular imaging of Tc99m tilmanocept and clinical assessments at predetermined intervals from time of initiation of anti-TNF alpha. Interim results previously announced in this trial have provided supportive evidence for Navidea's hypotheses that Tc99m tilmanocept imaging can potentially provide a robust, quantifiable imaging assessment of RA-involved joints that enable the early prediction for physicians to confirm the appropriate clinical response. Navidea remains on track to meet with the FDA to finalize the Phase 3 study design, and the Phase 2B trial will continue in parallel until completion.

08:01 EDT Avis Budget appoints Joe Ferraro as CEO - Avis Budget Group announced that its Board of Directors has appointed Joe Ferraro, who has been serving as interim CEO, as CEO, effective immediately. The Company also announced that Bernardo Hees, who has been serving as Independent Chairman of the Board, has been named Executive Chairman. Mr. Hees will partner closely with Mr. Ferraro and the rest of the management team in the areas of strategy, finance and digital mobility initiatives to help drive the performance of the Company.

07:55 EDT Eagle Bulk Shipping closes on $22.6M term facility increase - Eagle Bulk Shipping announced that Eagle Bulk Ultraco LLC, a wholly-owned subsidiary of the Company, closed on a $22.6M incremental term loan under its existing five-year senior secured term loan facility, which bears an interest rate of LIBOR plus 2.50% and matures in 2024. The incremental amount of the facility is secured by two Ultramaxes the Company already owned, the M/V Hong Kong Eagle and M/V Santos Eagle. Net loan proceeds will be used for general corporate purposes. Financing for the incremental term loans under the facility has been provided by the Company's existing lenders: ABN AMRO, Credit Agricole Corporate and Investment Bank, Skandinaviska Enskilda Banken AB, and DNB Bank ASA, and Danish Ship Finance.

07:51 EDT Walmart partners with Shopify, to open Walmart Marketplace to Shopify sellers - Jeff Clementz, Vice President, Walmart Marketplace (WMT), announced in a corporate blog post: "For years, building an eCommerce Marketplace customers trust has been a priority for our business. That's why we are joining forces with Shopify, an all-in-one commerce platform used by more than 1 million businesses, to open the Walmart Marketplace to their sellers. As our CEO Doug McMillon recently said, competition is good in the retail business, and we want more retailers not fewer. The U.S. eCommerce business grew 74% in total last quarter, and growth in marketplace outpaced the overall business even as first-party sales were strong. As we launch this integration with Shopify, we are focused on U.S.-based small and medium businesses whose assortment complements ours and have a track record of exceeding customers' expectations." In pre-market trading, Shopify (SHOP) shares are up about 6% to $786.98. Reference Link

07:47 EDT Repligen appoints Carrie Eglinton Manner to board of directors - Repligen Corporation (RGEN) announced the appointment of Carrie Eglinton Manner to its Board of Directors. She currently serves as Senior Vice President, Advanced Diagnostics at Quest Diagnostics (DGX).

07:44 EDT Medley Capital says Houlihan Lokey commences strategic review process - The Special Committee continues to explore strategic alternatives seeking to maximize shareholder value. Houlihan Lokey, the Special Committee's financial advisor, has commenced a strategic review process, which is ongoing. "The Expense Support Agreement is a near-term valuable step in making the Company more efficient through lowering its cost structure," said David Lorber, Chair of the Special Committee.

07:43 EDT Iovance Biotherapeutics disclosed resignation of CFO Timothy Morris - Iovance Biotherapeutics disclosed late Friday Timothy Morris no longer serves as the company's Chief Financial Officer, effective as of June 10. Effective as of June 10, Michael Swartzburg, the company's Vice President, Finance, was appointed to replace Morris as the interim Principal Financial Officer and Principal Accounting Officer. Swartzburg has served as the company's Vice President, Finance since March 2018. Previously, Mr. Swartzburg provided contracted financial and board of director advisory services to various public and private biotechnology and technology companies from August 2016 through March 2018.

07:41 EDT Auxly's JV partner Sunens Farms receives cultivation license - Auxly Cannabis Group announced that its joint venture partner, Sunens Farms, has secured a standard cultivation licence from Health Canada for the first phase of its fully automated, purpose-built, 1.1 million sq. ft. greenhouse facility in Leamington, Ontario. The Sunens facility is operational and the team will immediately begin cultivating high-quality organic cannabis within the licensed area. This standard cultivation licence allows Sunens to commence bulk sales of cannabis following harvest without additional regulatory approvals. Sunens has secured a large and diverse genetic library consisting of over 200 unique strains. Cannabis harvested from the Sunens facility will support the production of Auxly's branded derivative cannabis products manufactured at the Company's Dosecann facility in Prince Edward Island. This first phase of the licensed area includes approximately 360,000 sq. ft. of cultivation, processing, and storage space. The Company anticipates that the additional licence amendments for the remaining phases will be submitted throughout the course of 2020, and upon receipt of such amendments, the entire cultivation footprint for the project will be licensed.

07:38 EDT Marinus appoints Martha Manning as VP, general counsel, secretary - Marinus Pharmaceuticals (MRNS) announced that Martha Manning, Esq., has been appointed VP, General Counsel and Secretary. Immediately prior to joining Marinus, Manning was EVP, General Counsel and Secretary for Achillion Pharmaceuticals (ACHN).

07:36 EDT Venus Concept announces FDA 510(k) clearance for Venus Epileve - Venus Concept announced that it has received FDA 510(k) clearance to market and sell Venus Epileve. It is intended for treatment of hair removal, permanent hair reduction and pseudofolliculitis barbae. Venus Epileve represents a new product introduction by Venus Concept to the U.S. aesthetics market that expands the Company's diode laser hair removal offering beyond the Venus Velocity which was introduced to the medical aesthetics market in 2017. The Venus Epileve is cost-effective, fast, comfortable, and can be used on all skin types, including tanned skin. The Venus Epileve is a portable and versatile tabletop device that offers two modes of operation and a real-time cooling system aimed at ensuring patient safety and comfort. The Venus Epileve is integrated with Internet of Things technology that collects technical information to help providers enhance business operations and improve treatment efficiency.

07:35 EDT Genocea files IND application for GEN-011 - Genocea Biosciences announced the filing of an Investigational New Drug Application with the U.S. Food and Drug Administration to begin a Phase 1/2a clinical study of GEN-011 in a range of tumor types, with a focus on patients who have failed standard-of-care checkpoint inhibitor therapy. The GEN-011 trial will evaluate patient safety, T cell proliferation and persistence, and clinical activity, with preliminary data expected mid-2021. The company said, "Powered by ATLAS, GEN-011 offers several advantages over TIL therapies, the gold standard for solid tumor adoptive cell therapy. Unlike TILs, GEN-011 does not require extra surgery or collection of viable tumor samples and uses peripheral blood in a rapidly scalable manufacturing process. This may enable access to a broader population of patients with advanced cancers, and may result in a cost of therapy that is favorable compared to TIL-based approaches. GEN-011 may also offer lasting clinical efficacy by targeting up to 30 relevant neoantigens with CD4+ and CD8+ memory T cells and avoiding pro-tumor Inhibigens that may be detrimental to clinical response."

07:34 EDT Bellicum receives IND clearance to initiate Phase 1/2 trial for BPX-063 - Bellicum Pharmaceuticals announced clearance by the U.S. Food and Drug Administration of its investigational new drug application for BPX-603. BPX-603 is a GoCAR-T product candidate targeting solid tumors that express human epidermal growth factor receptor 2. BPX-603 is the company's first dual-switch GoCAR-T product candidate, which incorporates both the company's iMC activation and CaspaCIDe safety switch technologies. HER2 is a validated antigen for cancer therapies and academic CAR-T cell clinical studies have shown evidence of modest antitumor activity. BPX-603 was designed to improve upon these efforts, primarily through incorporation of the inducible co-activation domain MyD88/CD40, or "iMC". MC signaling is believed to boost effector cell proliferation and survival; enhance functional persistence by resisting exhaustion and the suppressive tumor microenvironment; and stimulate the cancer patient's own immune system. Additionally, Bellicum's dual-switch technology-which enables the clinician to either activate or eliminate GoCAR-T cells with the administration of small molecules-is designed to enhance real-time control of both efficacy and safety.

07:32 EDT Vaxart appoints Andrei Floroiu as CEO - Vaxart (VXRT) announced that it has appointed Andrei Floroiu as CEO. He has served as a member of Vaxart's Board of Directors since April 2020 and will continue on the board while serving as CEO. Wouter Latour, MD will remain as Chairman of the Board and a director of the Company. Floroiu was most recently with Agenus (AGEN), an immuno-oncology and vaccine pioneer, where he held executive positions and was responsible for structuring strategic partnerships and other transactions.

07:32 EDT Catalent signs agreement with AstraZeneca to manufacture COVID-19 vaccine - Catalent (CTLT) announced that Catalent Biologics will provide vial filling and packaging capacity to AstraZeneca (AZN) at Catalent's manufacturing facility in Anagni, Italy, and prepare for large-scale commercial supply of the University of Oxford's adenovirus vector based COVID-19 vaccine candidate, AZD1222. Catalent said in a release, "The agreement accelerates the rapid scale-up of capacity over the coming months to support the dedicated production of AZD1222. Catalent will prepare the facility to enable round-the-clock manufacturing schedules and supply hundreds of millions of doses of the vaccine candidate from August 2020, and potentially through to March 2022 should the product be approved by regulatory agencies. The recombinant adenovirus vaccine technology was created by the Jenner Institute at the University of Oxford, and the vaccine candidate is currently in clinical trials."

07:30 EDT Alliance Data reports May net charge offs 8.0% vs. 7.3% last month - Reports May delinquency ratio 4.8% vs. 5.6% last month.

07:30 EDT BeyondSpring trading resumes

07:28 EDT Myriad Genetics announces favorable coverage policies for Prolaris - Myriad Genetics announced that the company has received favorable coverage decisions for Prolaris from three new commercial health plans including one of the top five national providers of health insurance. The first new coverage policy which can be viewed here became effective June 8, 2020, the second new coverage policy becomes effective on June 15, 2020 and the third new coverage policy which can be viewed here becomes effective on July 31, 2020. In combination, these health plans cover approximately 26 million commercial lives bringing total commercial coverage for Prolaris up to 55 million lives.

07:27 EDT aTyr Pharma announces dosing of first patient in Phase 2 trial of ATYR1923 - aTyr Pharma announced that it has dosed the first patient in a Phase 2 study evaluating its lead therapeutic candidate, ATYR1923, in COVID-19 patients with severe respiratory complications. The study is expected to enroll 30 patients at up to 10 centers in the U.S. and the company expects to have the majority of centers enrolling within the coming weeks. ATYR1923 is a potential first-in-class immunomodulator that has been shown preclinically to downregulate T-cell responses and improve inflammation and lung function. ATYR1923 is currently being evaluated in a Phase 1b/2a multi-center trial for patients with pulmonary sarcoidosis, a serious inflammatory lung disease. There is strong scientific rationale for the hypothesis that ATYR1923 may help regulate the excessive inflammatory response in the lungs, primarily driven by T-cells, seen in many COVID-19 patients. The Phase 2 clinical trial is a randomized, double blind, placebo-controlled study of ATYR1923 in hospitalized COVID-19 positive patients with severe respiratory complications who do not require mechanical ventilation. Patients enrolled in the trial will be assigned to one of three cohorts of 10 patients each. Patients will receive a single intravenous dose of either 1.0 or 3.0 mg/kg ATYR1923 or placebo. Patients will be followed for 60 days post treatment. The trial is designed to evaluate the preliminary safety and efficacy of ATYR1923 as compared to placebo through the assessment of key clinical outcome measures such as fever and hypoxia as well as inflammatory biomarkers.

07:24 EDT XPO Logistics announces expanded COVID-19 response actions - XPO Logistics has released an expanded list of actions the company has taken for the safety of its employees and customers. Most recently, XPO deployed a COVID-19 dashboard on its XPO Connect digital freight platform in North America and Europe. The dashboard gives customers and carriers access to pandemic-related alerts issued by states, provinces, countries and major infrastructure sources. Drew Wilkerson, president, North American transportation for XPO, will discuss the opportunities of a post-pandemic logistics market during a virtual panel discussion on June 16. The event is part of Logistics Industry United Against COVID-19, an online summit hosted by GLT Logistics. Registrations will help support the American Logistics Aid Network, an organization that connects non-profit disaster relief organizations with supply chain resources. XPO's comprehensive COVID-19 response efforts include numerous protocols implemented to protect the physical, financial and emotional well-being of its employees: Employees work remotely if able to do so. For employees who need to work on site, XPO follows the guidance of the World Health Organization, the US Centers for Disease Control, local regulators, and the company's own health and safety protocols. Physical distancing and PPE guidelines are in effect at all XPO workplaces. XPO facilities engage in ongoing cleaning of high-touch areas, as well as deep cleaning of any equipment or area of a facility likely to have been exposed to COVID-19. XPO guarantees up to three additional paid days for employees of a facility that closes temporarily for deep cleaning. The company added Pandemic Paid Sick Leave to its US and Canadian benefits packages. XPO continues to provide alternate work arrangements for employees when medically advisable. The company provided Frontline Employee Appreciation Pay to US and Canadian employees. XPO expanded access to mental health counseling services. For its customers and carriers, XPO added a new electronic dashboard to its XPO Connect digital freight platform. The dashboard serves as an access point for pandemic-related alerts in North America and Europe issued by states, provinces, countries and major infrastructure sources, such as municipalities and airports.

07:21 EDT Mapi Pharma announces additional $20M investment from Mylan - Mapi Pharma announced an additional $20M investment from Mylan in support of continued Phase 3 clinical study progress to bring to market in the U.S. Glatiramer Acetate Depot, a proposed once-monthly injection for the treatment of patients with relapsing-remitting multiple sclerosis. In October 2019, Mapi Pharma initiated the Phase 3 study or relapsing-remitting multiple sclerosis, or RRMS, which is a 1,000 patient pivotal clinical study designed to support a New Drug Application with the U.S. Food and Drug Administration. To date, the study enrollment has been progressing well with more than 170 patients dosed across 56 sites. In parallel, Mapi is also building capacity at its facility to supply GA-Depot for commercial sale, pending final approval by the FDA.

07:19 EDT Applied Therapeutics releases additional data from adult galactosemia study - ACTION-Galactosemia is a Phase 1/2 clinical trial of the CNS penetrant Aldose Reductase inhibitor AT-007 in healthy volunteers and adults with Galactosemia. The biomarker-based pivotal study targeted reduction in plasma galactitol, an aberrant toxic metabolite of galactose formed by Aldose Reductase in Galactosemia patients. Accumulation of galactitol causes long-term complications ranging from CNS dysfunction to cataracts. Previously, Applied Therapeutics reported safety and efficacy data demonstrating a rapid and robust reduction in galactitol from baseline at 20mg/kg. The reduction in galactitol at 20mg/kg was statistically significant vs. placebo and did not result in any compensatory increase in other galactose metabolites, such as Gal-1p. Because there were no dose-limiting safety issues at 20mg/kg (and no drug-related adverse events overall), a higher dose cohort at 40mg/kg was initiated to fully explore optimal dosing in adults with Galactosemia. Once-daily 40 mg/kg AT-007 resulted in plasma galactitol reduction of 55%, an incremental improvement in efficacy vs. the 20mg/kg dose. Reduction in galactitol was statistically significant vs. placebo. All patients on the 40 mg/kg dose demonstrated significant reduction in galactitol from baseline, and reduction in galactitol was rapid and sustained over the 28-day dosing period. 40mg/kg was safe and well-tolerated with no drug-related adverse events reported, and no compensatory increase in galactose or other metabolites, such as Gal-1p. The 90-day extension study of AT-007 in adult Galactosemia patients remains ongoing. Patients who completed the 40mg/kg cohort have rolled into the 3-month safety extension study. The extension study is open to patients from the core study and to new adult Galactosemia patients. To date, the drug has been shown to be safe and well tolerated, and all patients enrolled in the study remain on treatment.

07:18 EDT Ingersoll-Rand CFO Emily Weaver to leave, Vikram Kini to succeed - Ingersoll Rand appointed Vikram Kini as its senior VP and CFO, reporting to Vicente Reynal, CEO. Kini will be succeeded by Kristen Actis-Grande as VP of investor relations and financial planning and analysis. Emily Weaver, current CFO is leaving to pursue other opportunities based on a mutual decision of her and the company. Weaver will remain with the company through the end of the month to assist in the transition to Kini. As senior VP and CFO, Kini will oversee all finance and accounting, including controllership, tax, treasury, planning, and investor relations, as well as information technology. Kini has a financial background spanning nearly 20 years, which includes almost 10 years with Ingersoll Rand where he has held various senior positions across the organization, most recently leading the global FP&A organization and serving as the head of investor relations.

07:18 EDT Abiomed appoints Charles Simonton, M.D. as chief medical officer - Abiomed announced it has appointed Charles Simonton, M.D., as vice president and chief medical officer. Dr. Simonton was most recently at Abbott Vascular where he served as chief medical officer and divisional vice president of Global Medical Affairs since 2008.

07:15 EDT Canopy Rivers names Mike Lee to board of directors - Canopy Rivers (CNPOF) welcomed Canopy Growth (CGC) CFO Mike Lee to its Board of Directors. The company expects that Lee's experience at Canopy Growth, Constellation Brands (STZ), and other leading consumer packaged goods and beverage companies will help strengthen its strategic execution as it continues to focus on developing a leading global cannabis portfolio.

07:14 EDT Innovative Industrial Properties raises Q2 dividend to $1.06 per share - Innovative Industrial Properties announced that its board has declared a Q2 dividend of $1.06 per share of common stock, representing a 6% increase over IIP's Q1 dividend of $1.00 per share of common stock. The dividend is equivalent to an annualized dividend of $4.24 per common share, and is the seventh dividend increase since IIP completed its initial public offering in December 2016. The dividends are payable on July 15, to stockholders of record at the close of business on June 30.

07:12 EDT Momenta says Phase 2 Vivacity-MG study of nipocalimab met primary endpoint - Momenta Pharmaceuticals announced positive topline data from an interim analysis of its Phase 2 Vivacity-MG study of nipocalimab in generalized myasthenia gravis. All four treatment arms showed efficacy in the myasthenia gravis activities of daily living score, the primary endpoint. Additionally, all dosing arms showed strong safety and tolerability profiles. The Vivacity-MG study, initiated April 2019, is a Phase 2, multicenter, randomized double-blind, placebo-controlled study evaluating the safety, efficacy, pharmacokinetics and pharmacodynamics of nipocalimab in 68 patients with moderate-to-severe generalized MG. The 8-week treatment period included four active arms and one placebo arm. The primary endpoint of the study was to reach statistically significant change from the baseline score of the myasthenia gravis Activities of Daily Living score. 52% of patients who received nipocalimab had rapid, significant and durable reductions in MG-ADL scores across all four dosing arms, versus 15% of placebo treated patients. A statistically significant relationship was observed between IgG reduction and clinical benefit for patients taking nipocalimab. Patients across all four nipocalimab dosing arms showed rapid reductions in MG-ADL scores, with clinically meaningful changes from baseline within two weeks. Nipocalimab was well tolerated, safe and efficacious in gMG patients. There were no severe or serious nipocalimab-related adverse events and most adverse events were characterized as mild. The study findings support continued clinical development in gMG and subcutaneous formulation dose selection. The study is expected to be completed in the third quarter of 2020. The Company plans to present the 16-week data with analysis of secondary endpoints and importantly, duration of efficacy, in the fourth quarter 2020. Based on the data, the Company has begun preparations to conduct end of Phase 2 meetings with regulatory agencies before the end of 2020.

07:10 EDT Catalyst Biosciences presents final data from Phase 2b trial of DalcA - Catalyst Biosciences announced final efficacy and safety data from its Phase 2b trial of DalcA, a next-generation subcutaneously administered Factor IX therapy being developed for the treatment of Hemophilia B. The poster was presented at the World Foundation of Hemophilia Virtual Summit, taking place from June 14 -19, 2020. The poster, entitled: "Phase 2b Trial to evaluate the safety and factor IX levels of a daily subcutaneous prophylaxis treatment regimen of dalcinonacog alfa in Hemophilia B" presented by Howard Levy, M.B.B.Ch., Ph.D., M.M.M., chief medical officer, Catalyst Biosciences highlights results from the study. Data from the trial showed that 28 days of daily SQ dosing of DalcA achieved protective target FIX levels of greater than12% in all participants, with FIX levels of up to 27% and a half-life of 2.5 to 5.1 days with no bleeds, demonstrating effective prophylaxis and the potential for lower or less frequent dosing. Injection volumes were less than 1 mL. One subject withdrew on day 7 after reporting injection site reactions from the first 3 SQ doses. No neutralizing anti-drug antibodies were detected and no serious adverse events were reported. Some subjects reported mild ISR of pain and/or redness, primarily with the initial injections. No thrombotic events occurred and blood coagulation markers of d-dimer, prothrombin fragment 1+2, thrombin-antithrombin and fibrinogen did not show any prothrombotic signals. The trial was designed to evaluate daily SQ dosing and the ability to maintain protective steady state FIX levels above 12% in six individuals with severe Hemophilia B. Each subject received a single intravenous dose, followed by daily SQ doses of DalcA for 28 days whereby the pharmacokinetics, pharmacodynamics, safety, tolerability and anti-drug antibody formation were monitored.

07:05 EDT Tela Bio announces poster presentations at 2020 MISS - TELA Bio announced that two abstracts focused on evaluating OviTex products have been accepted for poster presentations at the 20th annual Minimally Invasive Surgery Symposium. The MISS conference will take place virtually from June 9 through June 24, 2020. In one poster presentation, titled, "Reinforced Biologics in MIS Ventral Hernia Repair," author Geoffrey Slayden, MD, FACS, on behalf of the BRAVO study group, provides results for the 31 ventral hernia patients repaired minimally invasively, either robotically or laparoscopically, at approximately one-year follow-up. Low rates were reported for both surgical site occurrence and hernia recurrence. All investigators additionally found OviTex to be easy to use and place in the surgical field. In a second poster presentation, titled, "Using a Reinforced Biologic Mesh in a Minimally Invasive Technique for Ventral Hernia Repair," lead author Paul Szotek, MD, Medical Director of the Indiana Hernia Center, describes a novel single incision technique using OviTex to repair ventral hernias in 27 complex patients. Dr. Szotek reports no cases of recurrence and a low rate of SSO at an average follow-up of 9 months despite a challenging patient population.

07:04 EDT Abbott: FDA clears FreeStyle Libre 2 iCGM system in U.S. - Abbott announced the U.S. FDA cleared its next-generation FreeStyle Libre 2 integrated continuous glucose monitoring system for adults and children ages 4 and older with diabetes. This is the only iCGM system with optional real-time alarms that measures glucose levels every minute, meeting the highest level of accuracy standards over 14 days, including superior day one accuracy compared to the other iCGM and excellent accuracy and alarm performance at low end glucose levels. With a 14-day wear time, the FreeStyle Libre 2 system is the longest-lasting, self-applied iCGM sensor currently available, eliminating the need for fingersticks- and priced at a third of the cost of other CGM systems.

07:02 EDT Honeywell, KIPIC extend strategic collaboration - Honeywell and Kuwait Integrated Petroleum Industries Company have extended their strategic collaboration, signing a five-year, multi-million dollar contract for services to protect, maintain and optimize operations at the Al Zour refinery and liquefied natural gas import terminal in southern Kuwait. The contract will see the deployment of Honeywell Forge, an advanced Enterprise Performance Management software platform with robust cybersecurity capabilities that simplify, strengthen and scale industrial cybersecurity operations. The implementation will bolster network and endpoint security at KIPIC's new 615,000 barrel per day crude refining plant and three trillion British thermal unit per day LNG import facility. Honeywell Assurance 360, an outcome-based, performance-focused service management program, will also be implemented at the sites.

06:57 EDT Intracoastal Capital reports 4.99% passive stake in Summit Wireless

06:56 EDT BeyondSpring trading halted, news pending

06:52 EDT Eli Lilly begins baricitinib Phase 3 clinical trial - Eli Lilly announced that the first patient has been enrolled in a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of baricitinib, an oral JAK1/JAK2 inhibitor licensed from Incyte, in hospitalized adults with COVID-19. Eli Lilly said in a release, "Baricitinib, marketed as OLUMIANT, is approved in 70 countries as a treatment for adults with moderately to severely active rheumatoid arthritis, or RA. Lilly expects to enroll 400 patients in the trial, with data expected in the next few months. The study will be conducted in the U.S., Europe and Latin America and includes patients hospitalized with SARS-CoV-2 infection who have at least one elevated marker of inflammation but do not require invasive mechanical ventilation at study entry. In COVID-19 infection, increased disease severity can be associated with a hyperinflammatory state. It is hypothesized that through JAK1 and JAK2 inhibition, baricitinib may reduce the cytokine storm associated with the complications of this infection. In addition, baricitinib may have a role in inhibiting the host cell proteins that assist in viral reproduction, reducing the ability of infected cells to make more virus. A manuscript detailing this mechanism of action of baricitinib in COVID-19 has been accepted for publication by EMBO Molecular Medicine. The primary endpoint for Lilly's study is the proportion of patients who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation by Day 28 in patients treated with 4 mg of baricitinib daily (with background therapy) compared to placebo (with background therapy). Patients will receive baricitinib or placebo for up to 14 days or until discharge from the hospital. Key secondary outcomes of this study include the proportion of patients with clinical improvement at different time points, time to recovery, duration of hospitalization, number of ventilator-free days and mortality over a 28-day period."

06:41 EDT Synchrony reports May net charge-off rate 4.17% vs. 4.61% last month - Reports May 30-plus day delinquencies 2.20% vs. 2.47% last month.

06:37 EDT Brickell Biotech: All endpoints met in Phase 3 study of sofpironium bromide - Brickell Biotech announced the release of positive Phase 3 pivotal study results from its development partner, Kaken Pharmaceutical Co. Ltd., in Japan. All primary and secondary efficacy endpoints of the study were met. The results were presented as part of the Late-Breaking Research Program during the American Academy of Dermatology Virtual Meeting Experience. The presentation is titled "A Phase 3, Randomized, Double-Blinded, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Topically Applied Sofpironium Bromide Gel, 5% in Japanese Patients with Primary Axillary Hyperhidrosis." Earlier this year, Kaken announced submission of a new drug application for approval in Japan of manufacturing and marketing of sofpironium bromide gel for primary axillary hyperhidrosis based on these data. "We are encouraged by these positive results and are pleased by the filing of the Japanese New Drug Application based on this Phase 3 study by Kaken," said Deepak Chadha, Brickell's Chief Research & Development Officer. "We believe there is growing interest from the global medical community for novel therapeutic options for the treatment of primary axillary hyperhidrosis and think these data provide additional clinical support for sofpironium bromide to be a potential best-in-class treatment."

06:33 EDT 3M reports May sales of $2.2B, down 20% y/y - 3M reported sales information for the month of May. Total sales for May declined 20% year-on-year to $2.2B. Organic local-currency sales (which includes organic volume impacts and selling price changes) declined 21% while acquisitions, net of divestitures, increased sales by 2%. Foreign currency translation reduced sales by 1% year-on-year. Total sales declined 11% in Health Care, 12% in Consumer, 17% in Safety and Industrial, and 30% in Transportation and Electronics. Organic local-currency sales declined 11% in Consumer, 15% in Safety and Industrial, 22% in Health Care, and 28% in Transportation and Electronics. On a geographic basis, total sales declined 15% in Asia Pacific, 21% in the Americas, and 26% in EMEA (Europe, Middle East and Africa). Organic local-currency sales declined 15% in Asia Pacific (including China down 6% and Japan down 18%), the Americas declined 24% (including the U.S. down 22%), and EMEA declined 25%. The above sales information for May 2020 was impacted by two fewer business days - 20 days this year versus 22 days last year - or a minus 9% year-on-year impact. The company will have two additional business days in June 2020 versus June 2019. As a result, there will be no year-on-year business day impact for the second quarter.

06:22 EDT Iveric bio announces 18-month Zimura trial data - Iveric bio announced 18-month results from the company's first Phase 3 clinical trial for Zimura, a novel complement C5 inhibitor, for the treatment of geographic atrophy, or GA, secondary to age-related macular degeneration, or AMD. The 18-month data supports the previously announced 12-month data from this trial, at which time point Zimura met the pre-specified primary efficacy endpoint with statistical significance. The reduction in the mean rate of GA growth over 18 months was 28.11% for the Zimura 2 mg group as compared to the corresponding sham control group and 29.97% for the Zimura 4 mg group as compared to the corresponding sham control group. The pre-specified efficacy analysis for the primary endpoint was performed at month 12 using all of the power in the trial to detect a statistically significant difference. Therefore, the p-values for the 18 month statistical analyses are descriptive in nature. The descriptive p-values for the treatment effects at month 18 were 0.0014 for the Zimura 2 mg group and 0.0021 for the Zimura 4 mg group. In this trial, the treatment effect was observed as early as six months, with an increase in the absolute difference of the mean change in GA growth for treatment with either Zimura 2 mg or Zimura 4 mg, as compared to sham, at each subsequent time point, suggesting the progressive benefit of continuous treatment with Zimura. Zimura maintained its favorable safety profile at 18 months with no reported Zimura related adverse events, no cases of endophthalmitis and a lower rate of choroidal neovascularization, or CNV, than reported for C3 inhibition. The overall 18 month data may suggest a dose response relationship. Mean rate of change in GA growth over 18 months, was measured by fundus autofluorescence, or FAF, based on readings at four time points (baseline, month 6, month 12 and month 18) and was calculated using the square root transformation of the GA area. The FAF images were assessed by an independent masked reading center. The prespecified statistical analysis plan used a model of repeated measures, or MRM, to compare data for the Zimura 2 mg and Zimura 4 mg groups to the corresponding sham groups. Zimura was generally well tolerated after 18 months of administration. There was no Zimura-related inflammation, no Zimura-related discontinuations from the trial, no cases of endophthalmitis and no Zimura-related adverse events. Through month 18, the reported incidence of CNV in the untreated fellow eye was 11 patients and in the study eye was 3 patients in the sham control group, 8 patients in the Zimura 2 mg group and 13 patients in the Zimura 4 mg group. The most frequently reported ocular adverse events were related to the injection procedure.

06:06 EDT Smart Sand regains Nasdaq compliance - Smart Sand announced that it has received notification from the Nasdaq Stock Market that the company has regained compliance for continued listing on Nasdaq. On May 14, the company was notified by Nasdaq that for 30 consecutive business days preceding the date of the notice, the bid price of the company's common stock had closed below the $1.00 per share minimum required for continued listing on Nasdaq pursuant to Nasdaq minimum bid price requirements. On June 11, the company was notified by Nasdaq that for 10 consecutive business days from May 28 through June 10, the bid price of the company's common stock had closed at or above $1.00 per share and the company had regained compliance with the Nasdaq continued listing rules.

06:05 EDT Xeris Pharmaceuticals reports 'positive' results from study of Gvoke RTU Micro - Xeris Pharmaceuticals announced positive topline results from the outpatient stage of a Phase 2 study of its developmental Gvoke RTU Micro for the prevention of hypoglycemia during and after moderate-to-high intensity aerobic exercise in adults with Type 1 diabetes mellitus who use insulin pumps. The clinical data was presented at a late-breaking session at the American Diabetes Association being held as a virtual event on June 12-16. In the outpatient stage of this study, subjects were randomly assigned to RTU Glucagon with 50% insulin pump reduction; placebo injection with 50% insulin pump reduction; or RTU Glucagon without insulin pump reduction. For persons with diabetes, standard of care for aerobic exercise includes 50% insulin pump reduction. Results show that pretreatment with 150 microgram of RTU glucagon was adequate to maintain normal blood glucose levels during prolonged, moderate-to-intense aerobic exercise. During the 12-week outpatient stage, 45 subjects completed 795 aerobic exercise sessions. Over this time when individually compared to standard of care alone, the number of EIH episodes was significantly less with RTU Glucagon + standard of care, and with Open Label RTU Glucagon. RTU Glucagon + standard of care resulted in an approximately 70% lower rate of EIH when compared to standard of care alone. Additionally, Open Label RTU Glucagon resulted in an approximately 54% lower rate of EIH when compared to standard of care alone. The difference in the incidence rates of EIH between the two RTU Glucagon arms was not statistically significant.

05:54 EDT BP sees Q2 impairment charges and write-offs of $13B-$17.5B - BP announced that as part of its strategy development, it has been reviewing its portfolio and its capital development plans. The company said, "This work is informed by bp's views of the long-term price environment and its balanced investment criteria. Together these create a framework that seeks to ensure investments align with its strategy and add shareholder value. In addition, with the COVID-19 pandemic having continued during the second quarter of 2020, bp now sees the prospect of the pandemic having an enduring impact on the global economy, with the potential for weaker demand for energy for a sustained period. bp's management also has a growing expectation that the aftermath of the pandemic will accelerate the pace of transition to a lower carbon economy and energy system, as countries seek to 'build back better' so that their economies will be more resilient in the future." As a result, BP has revised its long-term price assumptions, lowering them and extending the period covered to 2050. As part of its long-term strategic planning, and in the context of its continuing focus on capital discipline, BP said is also reviewing its intent to develop some of its exploration intangible assets. These actions will lead to non-cash impairment charges and write-offs in Q2, estimated to be in an aggregate range of $13B to $17.5B post-tax. Reference Link

05:26 EDT Accenture announces intent to acquire Sentelis, terms not disclosed - Accenture has entered into an agreement to acquire Sentelis, an independent data consulting and engineering company, headquartered in France, that specializes in designing and scaling data and artificial intelligence, or AI, capabilities. Accenture said in a release, "Sentelis would join Accenture Applied Intelligence and complement its focus on helping clients build the right data strategy and foundation to industrialize AI across their businesses. With a strong focus on industrializing AI and big data technologies, Sentelis has more than 50 highly skilled professionals, including data and AI advisors, architects and engineers. Since its founding in 2011, Sentelis has helped numerous clients, including some of the largest French companies, architect, engineer and scale adapted and secure data-centric architecture, enabling them to accelerate business innovation. The combination of Sentelis's industry experience, particularly in financial services and retail, with Accenture's expertise in global large-scale artificial intelligence and machine learning engineering initiatives would provide highly differentiated end-to-end services to the European market. This acquisition would strengthen Accenture's growing analytics, AI and ML/data engineering business in France. Global growth in AI client engagements has also served as a driver for Accenture's recent acquisitions of Analytics8 in Australia, Pragsis Bidoop in Spain, Clarity Insights in North America, Mudano in the UK and Byte Prophecy in India. The acquisition requires prior consultation with the relevant works councils and would be subject to customary closing conditions. Financial terms of the transaction are not being disclosed."

05:17 EDT Extraction Oil & Gas voluntarily files for Chapter 11 - Extraction Oil & Gas announced that the company has voluntarily filed for petitions for relief under chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court for the District of Delaware. Extraction Oil & Gas said in a release, "The Company has obtained a committed $125 million debtor-in-possession financing facility, which contemplates $50 million in new money, up to $15 million of which will become immediately available upon Bankruptcy Court's order, and a "roll up" of $75 million of revolving loans under the Company's existing revolving credit agreement. The DIP Facility is underwritten by Wells Fargo Bank, National Association and the $50 million in new money is financed by certain lenders under the Company's existing revolving credit agreement. Subject to Court approval, this DIP financing, combined with the Company's cash from operations, is expected to provide sufficient liquidity during the chapter 11 cases to support its continuing business operations and minimize disruption. Further, to facilitate the Company's swift exit from chapter 11, the Company announced it has entered into a restructuring support agreement with certain of its unsecured noteholders. The Agreement outlines a restructuring plan that will effectuate a significant deleveraging of the Company's balance sheet through a debt-for-equity swap, pursuant to either a standalone restructuring or a combination transaction, that will leave the Debtors' unsecured noteholders with the majority of the Company's equity while still providing a meaningful recovery to junior stakeholders. Though the Company was unable to obtain consensus across its entire prepetition capital structure prior to filing, the Company plans to use the chapter 11 process to build consensus for a comprehensive restructuring transaction that will allow the Company to emerge from chapter 11 with a right-sized, flexible balance sheet. Extraction has filed a series of motions with the court that, when granted, are expected to generally enable the company to maintain its operations as usual throughout the restructuring process. Included in these first day motions are requests to continue to pay employee wages, honor existing employee benefit programs, continue to pay taxes, and pay royalties to mineral owners under the terms of the applicable agreements. The Company has also filed motions seeking authority to pay expenses associated with its drilling and production operations, as well as costs associated with gathering, processing, transportation and marketing those operations related to joint interest billing for non-operated properties."