Stockwinners Market Radar for September 18, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

17:52 EDT Condor Hospitality terminates merger agreement with NHT Operating Partnership - Condor Hospitality Trust announced that it has terminated its merger agreement with NHT Operating Partnership, the operating partnership of NexPoint Hospitality Trust and certain of its affiliates, effective immediately. Pursuant to its rights under the merger agreement, the company terminated the merger agreement due to failure of NHT's operating partnership to consummate the acquisition of the company and for material breaches of the merger agreement by NHT's operating partnership and its affiliates. Pursuant to the merger agreement, the company is entitled to receive a termination fee of $11.93M within five business days of its termination of the merger agreement. The company continues to reserve all other rights and remedies.

17:28 EDT Point72 reports 5.0% passive stake in Fulcrum Therapeutics - Point72 Asset Management disclosed a 5.0% stake in Fulcrum Therapeutics, which represents over 1.38M shares. The filing does not allow for activism.

17:20 EDT Starwood Capital reports 8.39% stake in MFA Financial - Starwood Capital disclosed a 8.39% stake in MFA Financial, which represents over 38.0M shares. The filing does allow for activism. The filing indicates that the "Reporting Persons may communicate with the board of directors of the Issuer, members of management and/or other stockholders or other relevant parties from time to time with respect to operational, strategic, financial or governance matters or otherwise work with management and the board of directors with a view to maximizing stockholder value."

17:02 EDT Granite Construction receives listing extension from NYSE - Granite Construction announced that it has received an extension for continued listing and trading of the company's common stock on the New York Stock Exchange, or NYSE. The extension of an additional six months gives the company until March 18, 2021 to file its annual report on Form 10-K for the year ended December 31, 2019 and its subsequent quarterly reports on Form 10-Q with the Securities and Exchange Commission, or SEC, subject to reassessment on an ongoing basis. The company can regain compliance at any time before that date by filing its 2019 Form 10-K and 2020 Form 10-Qs with the SEC. The NYSE will continue to closely monitor the company's restatement process and timing, and could initiate accelerated trading suspension prior to the end of the six-month extension if that process fails to progress satisfactorily during the extension. In addition, in the event the company does not file its 2019 Form 10-K and 2020 Form 10-Qs with the SEC by March 18, 2021, the NYSE will move forward with the initiation of suspension and delisting procedures.

17:00 EDT NorthWestern to transfer listing to Nasdaq - NorthWestern Corporation d/b/a NorthWestern Energy announced that it is transferring its stock exchange listing from The New York Stock Exchange after the end of trading on September 30, 2020 to The Nasdaq Global Select Market. NorthWestern's shares will begin trading as a Nasdaq-listed security on October 1, 2020 and will continue to trade under the ticker symbol NWE.

16:34 EDT American Renal Associates enters shareholder derivative litigation settlement - American Renal Associates announced that the company has received preliminary approval of the settlement of a stockholder derivative action brought by Plaintiff Luke Johnson and pending in the United States District Court for the District of New Jersey. The proposed settlement releases all claims asserted against the company and the other named defendants in the Johnson Action without any liability or wrongdoing attributed to them. The proposed settlement remains subject to court approval and other customary conditions. The proposed settlement does not involve a payment by or to ARA and will have no impact on ARA's financial condition or results of operations,

16:31 EDT AirNet Technology receives deficiency letter from Nasdaq - AirNet Technology announced that it received a notification letter dated September 16, 2020 from the Listing Qualifications Department of The Nasdaq Stock Market Inc. notifying that the company is no longer in compliance with the Nasdaq Listing Rule 5550b1 for continued listing due to its failure to maintain a minimum of $2.5 million in stockholders' equity. In the company's Form 20-F for the fiscal year ended December 31, 2019, the company reported a negative stockholders' equity of approximately $19 million. Nasdaq also determined that the company does not meet the alternatives of market value of listed securities or net income from continuing operations for continued listing. The Deficiency Letter does not result in the immediate delisting of the company's ordinary shares represented by American depositary shares on the Nasdaq Capital Market. The company has 45 calendar days from the date of the Deficiency Letter, or until November 2, 2020, to submit a plan to Nasdaq to regain compliance with the minimum stockholders' equity standard. If the Compliance Plan is accepted by Nasdaq, the company may be granted a compliance period of up to 180 calendar days from the date of the Deficiency Letter to evidence compliance. However, since Nasdaq previously notified the company that its bid price compliance period expires on December 10, 2020, the Compliance Plan shall also set forth a plan to address the minimum bid price requirement by such date.

16:17 EDT NTN Buzztime sells entertainment, advertising assets for $2M - NTN Buzztime signed a definitive asset purchase agreement to sell its social entertainment, customer engagement, and advertising technology assets to eGames.com Holdings for $2.0M in cash. The proposed transaction is expected to close in Q4 subject to the satisfaction or waiver of closing conditions in the purchase agreement. In consideration for the purchase of the assets, at the closing of the proposed transaction, eGames.com will pay $2.0M in cash to Buzztime and will assume certain of Buzztime's other liabilities necessary to operate the business. On the date the parties entered into the asset purchase agreement, an affiliate of eGames.com loaned $1M to Buzztime, which will be applied toward the purchase price at the closing of the asset sale.

16:13 EDT Shoe Carnival CEO sells 30K shares of common stock - In a regulatory filing, Shoe Carnival discloses that its CEO Clifton Sifford sold 30K shares of common stock on September 17th in a total transaction size of $1.18M.

16:05 EDT Byline Bank to consolidate 11 of its 57 full-service offices - Byline Bancorp announced plans to optimize its branch network as part of efforts to accommodate changing customer behaviors while also recognizing operating efficiencies. Byline Bank plans to consolidate 11 of its 57 full-service offices, or approximately 20% of its branch network. Byline Bank will continue to service all its current markets and the consolidations target branches that overlap with other locations. Most of the impacted branches are located within two miles of another Byline Bank branch that will continue to operate within the respective market. The 11 branch closures are scheduled to commence on December 31, 2020 and will result in a one-time charge of approximately $5.9 million. The Company anticipates annualized cost savings of approximately $4.3 million beginning in 2021, a portion of which will be utilized to increase Byline Bank's investment in its digital banking platform and the continued renovation and upgrading of other retail branches.

16:03 EDT D.E. Shaw reports 5.1% passive stake in Overstock.com - D.E. Shaw disclosed a 5.1% stake in Overstock.com, which represents over 2.18M shares. The filing does not allow for activism.

15:41 EDT Austin Holdco discloses 14.7% Virtusa stake - Austin Holdco disclosed a 14.7% stake in Virtusa, which represents over 4.75M shares. The filing does allow for activism.

14:55 EDT Pfizer's treatment for Sickle Cell Disease granted orphan designation - Pfizer's treatment for Sickle Cell Disease was granted orphan designation, according to a post to FDA website. Reference Link

14:49 EDT Amazon supports DOJ prosecution of defendants charged with fraud - After the United States Attorney's Office for the Western District of Washington brought charges against six individuals for conspiracy to use a communication facility to commit commercial bribery, conspiracy to access a protected computer without authorization, conspiracy to commit wire fraud, and wire fraud, Amazon issued the following statement: "Amazon is grateful to have worked with the United States Attorney's Office for the Western District of Washington, the Federal Bureau of Investigation, the Internal Revenue Service-Criminal Investigations, and the Department of Justice Office of International Affairs in their thorough pursuit of this case. We work hard to build a great experience for our customers and sellers, and bad actors like those in this case detract from the flourishing community of honest entrepreneurs that make up the vast majority of our sellers. Amazon has systems in place to detect suspicious behavior by sellers or employees, and teams in place to investigate and stop prohibited activity. We are especially disappointed by the actions of this limited group of now former employees, and appreciate the collaboration and support from law enforcement to bring them and the bad actors they were entwined with to justice. There is no place for fraud at Amazon and we will continue to pursue all measures to protect our store and hold bad actors accountable."

14:37 EDT Fluidigm extends rally, up 17% to $8.36 after Citron reiterates $20 target

14:03 EDT Denbury announces successful completion of financial restructuring - Denbury (DEN) announced that it has successfully completed its financial restructuring and emerged from Chapter 11. Denbury's common stock is expected to commence trading on the New York Stock Exchange under the ticker symbol DEN at market open Monday, September 21. Consistent with the previously announced Restructuring Support Agreement and the company's "pre-packaged" plan, Denbury has restructured its balance sheet and eliminated $2.1B of bond debt. Throughout the court-supervised process, Denbury has continued to operate without interruption while fully satisfying all trade, customer, employee, royalty owner, working, and other mineral interest claims in the ordinary course, the company stated. As disclosed on September 15, 2020, Denbury has changed its corporate name from Denbury Resources Inc. to Denbury Inc. Further information regarding the restructuring, including the securities being issued, the company's exit revolving credit facility, Denbury's newly appointed directors, and other matters associated with the restructuring will be provided in a Form 8-K to be filed later today, Denbury noted.

12:40 EDT TikTok CEO invites Facebook, Instagram to help fight TikTok ban - TikTok interim CEO Vanessa Pappas invited Facebook (FB) and Instagram to "publicly join" the company's challenge Trump's ban of the video-sharing app and "support our litigation." "This is a moment to put aside our competition and focus on core principles like freedom of expression and due process of law," Pappas tweeted. The comments come as the Commerce Department announced prohibitions on transactions relating to WeChat and TikTok as of Sunday on "national security" grounds. The Fly notes that TikTok's Chinese owner ByteDance has reached an agreement with Oracle (ORCL) to create TikTok Global, which would reportedly have a majority of American directors and a U.S. CEO. Reference Link

12:00 EDT American Axle falls -6.7% - American Axle is down -6.7%, or -42c to $5.85.

12:00 EDT Carnival plc falls -7.8% - Carnival plc is down -7.8%, or -$1.05 to $12.43.

12:00 EDT Contura Energy rises 15.5% - Contura Energy is up 15.5%, or 93c to $6.93.

11:13 EDT Nemaura Medical appoints Justin Mclarney as CFO - Nemaura Medical (NMRD) announces it has appointed Justin Mclarney as Chief Finance Officer, effective September 15. McIarney has held various Senior Finance & Operational roles, including most recently the position of Senior Director, International Finance at Lands' End (LE) from January 2016 to May 2020, where he was responsible for all Finance teams across the European and Japanese business units, Nemaura stated in its announcement of his appointment.

11:07 EDT Epic's 'Fortnite: Save the World' will no longer be playable on macOS - "Fortnite" creator Epic Games said that Apple (AAPL) is preventing Epic from signing games and patches for distribution on Mac, which ends the game maker's ability to develop and offer "Fortnite: Save the World" for the platform. Specifically, the upcoming v14.20 release will cause bugs for players on v13.40, resulting in a very poor experience. "Since we are no longer able to sign updates and release fixes for these issues, beginning September 23, 2020, Fortnite: Save the World will no longer be playable on macOS," Epic said, noting it will issue a refund for all players who purchased any "Save the World" Founder's or Starter Packs and played "Save the World" on macOS between September 17, 2019 and September 17, 2020. Investors in Epic include Tencent (TCEHY), KKR (KKR), Disney (DIS), and Sony (SNE). Reference Link

10:00 EDT ProSight falls -3.7% - ProSight is down -3.7%, or -37c to $9.59.

10:00 EDT Global Blue falls -4.6% - Global Blue is down -4.6%, or -36c to $7.47.

10:00 EDT Bloom Energy rises 10.7% - Bloom Energy is up 10.7%, or $1.55 to $16.10.

09:47 EDT ProSight falls -3.7% - ProSight is down -3.7%, or -37c to $9.59.

09:47 EDT China Eastern Airlines falls -4.6% - China Eastern Airlines is down -4.6%, or -$1.10 to $22.90.

09:47 EDT J. Alexander's rises 10.0% - J. Alexander's is up 10.0%, or 48c to $5.26.

09:26 EDT Radient announces strategic review of operations, names Jan Petzel interim CEO - Radient Technologies announces its Board of Directors is conducting a strategic review of the Company's operations targeting a path to positive cash flow by evaluating costs and under utilized assets. Radient will build on its recent successes in launching white label products and increasing its distribution to additional provinces. The review will address items that are strategic to the Company's operations and includes management changes being announced. The Board named Jan Petzel as Interim President and CEO, effective immediately. Mr Petzel has been a Director of the Radient since 2016 and has a comprehensive understanding of the Company, and a pragmatic view of the priorities that need to be addressed. Denis Taschuk will step down as President & CEO and Director of the Company, effectively immediately, for family reasons. He will continue as advisor to the Board to facilitate the transition to a new CEO. Mike Cabigon will step down as COO and Director of the Company, effective immediately, to pursue other interests.

09:05 EDT Generex signs licensing, research agreement with Bintai Kinden - Generex Biotechnology announced that the company and Bintai Kinden Corporation of Malaysia have signed an addendum binding the terms of the previously signed Memorandum of Understanding for the development and commercialization of the Ii-Key-SARS-CoV-2 coronavirus vaccine. Under the terms of the Addendum, Bintai and Generex will finalize the legal and contractual documentation for the contract, partnership, and licensing & research agreement, and Bintai will pay Generex an up-front licensing fee of $2.5 million within two weeks. Additionally, Bintai will pay 100% of the funding required for the commercial development of the Ii-Key-CoV-2 vaccine including laboratory work, manufacturing, regulatory filings and the clinical development program for regulatory approval of the vaccine in Malaysia. Also, upon approval of the Ii-Key-CoV-2 vaccine in Malaysia, Bintai will pay Generex a $17.5M milestone payment and Generex will earn royalties on sales of the vaccine equal to $3 per dose on government sales and $4.50 per dose in the private sector. Further, under this new Addendum, Bintai will have the right of first refusal for the Ii-Key-SARS-CoV-2 vaccine in Australia, New Zealand, and the global HALAL markets, particularly in Southeast Asia. Under terms of the deal, Generex and Bintai have agreed to collaborate and have developed a strategy towards the rapid development of the Ii-Key-CoV-2 vaccine for Malaysia. As part of that strategy, Generex has identified a local CRO, Jigsaw Clinical Research Solutions, managed by U.S. industry veteran, Jeffrey Yablon who has decades of experience in clinical development and regulatory affairs, and has established Jigsaw as the premier Malaysian CRO.

09:03 EDT Hailiang Education Group acquires Jinhua Hailiang Foreign Language School - Hailiang Education Group announced that the company has signed a sponsorship transfer agreement with its affiliate Hailiang Education Investment Group Co., Ltd. on July 15, to acquire Jinhua Hailiang Foreign Language School for a total consideration of RMB 34M from Hailiang Investment. After obtaining the relevant administrative approval on September 16, 2020, Hailiang Education completed all the required process to obtain the sponsorship of JHFL from Hailiang Investment. Prior to this transaction, Hailiang Education provided operation management services to JHFL.

09:00 EDT Arthur J. Gallagher acquires Erin P. Collins & Associates, terms not disclosed - Incorporated in 1994, ECA is an employee benefits and workplace wellbeing consultant serving clients throughout the state of Arizona from offices in Kingman and Phoenix.

08:51 EDT Westport reports JV's Chinese certification for WP12 engine - Westport Fuel Systems announced that its Weichai Westport Inc. joint venture has received certification from the Ministry of Ecology and Environment of China for its 12-liter engine equipped with the HPDI 2.0 fuel system, or the "WP12HPDI" Westport said: "WWI is now in a position to market and sell the heavy-duty natural gas engines with HPDI technology to various truck original equipment manufacturers. Weichai Power Co., Ltd's 12-liter heavy-duty engine platform is the base engine for the WP12HPDI." As per the terms of the earlier announced development and supply agreement, Westport Fuel Systems will supply critical HPDI 2.0 components to WWI, each of which is required for every engine equipped with HPDI and sold by WWI. Weichai Power and WWI are affiliates of the Weichai Holding Group Co., Ltd. Reference Link

08:47 EDT Blink Mobility acquires BlueLA Carsharing, terms not disclosed - Blink Charging announced that its wholly-owned subsidiary, Blink Mobility, has acquired BlueLA Carsharing, the City of Los Angeles' contractor for its EV carsharing services program, with 200 EV charging stations and 100 electric vehicles. The acquisition doubles the number of Blink stations in Los Angeles, making the use of EV cars more accessible to the community at large and supporting the City's commitment to reduce greenhouse gas emissions and reduce resident exposure to harmful pollutants. Blink plans to make considerable enhancements to the existing BlueLA infrastructure to improve the customer experience. Pending City approval, Blink will upgrade the charging infrastructure to its IQ 200 charging stations. Further, Blink plans to outsource and collaborate with an experienced mobility provider to improve the EV carsharing service and upgrade the vehicles to include more practical EVs that better meet consumer demand. Finally, the Company is exploring additional ancillary services, such as digital media at charging locations as well as in the interior and exterior of the vehicles, to enhance the driver experience while also better monetizing locations.

08:33 EDT PRA Health, Deep Lens announce strategic relationship for patient recruitment - PRA Health Sciences and Deep Lens announced a new strategic relationship to accelerate patient access and recruitment for oncology clinical trials. The relationship brings together best-in-class technologies that improve the identification, screening, and matching of cancer patients to precision-based clinical oncology trials on a global basis, with the combined solution being deployed to Microsoft Azure. Deep Lens' award-winning VIPER patient screening platform is a breakthrough technology deployed by cancer centers, integrated delivery networks, and community oncology networks to identify and match oncology patients to life saving clinical trials who would have otherwise fallen through the cracks and missed the opportunity to enroll. The differentiated technology and services model allows Deep Lens to deploy its software at cancer centers and site networks on a global basis, free of charge, to better give patients access to the therapies they need and deserve - while providing significant value by accelerating study timelines and bringing game-changing therapies to market sooner. The combined effort between PRA and Deep Lens brings a critical advancement to clinical trial matching to more efficiently connect eligible patients with potential clinical trials by leveraging artificial intelligence and machine learning via the VIPER platform.

08:19 EDT USA Technologies CAO Glen Goold to depart, Scott Stewart to succeed - USA Technologies (USAT) announced the appointment of Scott Stewart as the company's new chief accounting officer, or CAO, effective immediately. Stewart will lead the company's accounting operations, financial reporting, internal control processes and financial systems. Stewart joins the company after 13 years with the IntercontinentalExchange (ICE). During his time at ICE, he served in various positions, most recently as assistant controller, where his responsibilities included managing and overseeing the production of external financial statements, implementation of new accounting standards, maintaining corporate controls, ensuring SOX compliance across all accounting processes and working closely with the company's board and Audit Committee. Stewart will be based in the company's Atlanta office and report to CFO, Wayne Jackson. USAT's current CAO, Glen Goold, will stay with the company to assist in the transition of his responsibilities.

08:11 EDT ProPhase Labs announces $10M unsecured debt financing - ProPhase Labs announced that it has closed on a $10 million unsecured debt financing. The Company has issued two unsecured, partially convertible, promissory notes for an aggregate principal amount of $10M. Each Note is due and payable on the third anniversary of the date on which the Note was funded and accrues interest at a rate of 10% per year from the Closing Date, payable on a quarterly basis, until the Note is repaid in full. The Company has the right to prepay the Notes at any time after the 13 month anniversary of the Closing Date upon providing written notice to the lenders, and may prepay the Notes prior to such time with the consent of the lenders. The lenders have the right, at any time, and from time to time, on and after the 13 month anniversary of the Closing Date, to convert up to an aggregate of $3 million of the Notes into common stock of the Company at a conversion price of $3.00 per share. Repayment of the Notes has been guaranteed by the Company's wholly-owned subsidiary, Pharmaloz Manufacturing, Inc. The Company intends to use the proceeds from the Notes for working capital and general corporate purposes, which may include capital expenditures, product development and commercialization expenditures, and acquisitions of companies, businesses, technologies and products within and outside the consumer products industry.

08:08 EDT NetApp holder IsZo Capital issues letter to holders regarding strategic vision - IsZo Capital Management said in a release, "IsZo Capital Management, a significant long-term shareholder of Nam Tai Property with beneficial ownership of approximately 10% of the Company's outstanding shares, today issued a letter to shareholders in connection with its efforts to convene a meeting of Nam Tai shareholders. IsZo recently announced that it delivered to Nam Tai verified requests to convene the Special Meeting from holders of more than 40% of the Company's outstanding shares (well in excess of the 30% required to convene the Special Meeting). The Special Meeting will provide shareholders an opportunity to reconstitute Nam Tai's Board of Directors by removing a majority of the incumbent directors and installing six highly-qualified and independent individuals: Michael Cricenti, Cindy Chen Delano, Bo Hu, Louis Leung, Paula Poskon and Jeffrey Tuder. IsZo also wants to take this opportunity to urge Nam Tai to respect the will of shareholders and promptly schedule the Special Meeting. In addition to the fact that a critical mass of shareholders has requested the Special Meeting, the market has expressed significant enthusiasm for change at Nam Tai since IsZo first initiated its campaign earlier this year. The Company's share price has appreciated approximately 2.5x since our first letter on May 27." The letter states, "IsZo Capital Management LP believes the actions and public communications issued by Nam Tai Property in recent months collectively represent a clear indication that meaningful change is urgently needed in the boardroom. We believe it is important for shareholders to understand that a Board controlled by allies of Kaisa Group Holdings cannot be trusted and that IsZo's slate of director candidates is offering a superior strategic vision. We believe it is quite notable that one business day after IsZo delivered to Nam Tai verified requests to convene a meeting of shareholders from holders of more than 40% of the Company's outstanding shares, the Company announced that Chief Executive Officer and Chairman Ying Chi Kwok was immediately resigning from his positions. This recent announcement followed Nam Tai's August 5th proclamation that "Mr. Kwok has made significant progress driving value for shareholders" despite a -56.85% total shareholder return, or TSR, over his tenure... Shareholders should recognize that Nam Tai's announcement pertaining to Mr. Kwok's departure is only the latest in a string of contradictions and misrepresentations that the Company has disseminated. While Nam Tai will now likely claim that it is embracing shareholder feedback and taking steps to enhance value, we question how any shareholder can have faith in what remains a Kaisa-controlled Board. We contend the Company's recent communications, including its August 5th press release, feature a litany of misleading statements that completely impugn the Board's credibility... Nam Tai's lack of credibility and disregard for shareholders' interests to date only reinforces the urgent need to convene the Special Meeting. We urge the Company to avoid stalling or manufacturing unnecessary delays by promptly scheduling the Special Meeting that a critical mass of shareholders - including one of the Company's own Board members - has demanded... We urge shareholders to reject Nam Tai's appeal to give the Board more time to prioritize its own interests, and view the Company's defensive and reactionary changes as nothing more than ploys to benefit Kaisa. It should be clear based on the extremely strong market reaction to IsZo's efforts in recent days and months that many shareholders support the prospect of board-level change at Nam Tai. IsZo hopes this enthusiasm continues to grow now that our slate has provided an overview of a clear and viable strategy. IsZo also wants to note at this time that we firmly believe it is in the best interests of Nam Tai to maintain a degree of boardroom continuity and retain two incumbent directors with strong institutional knowledge and unimpeached integrity. To that end, our director candidates are very excited by the prospect of working with Peter Kellogg and Mark Waslen to relentlessly pursue the results that shareholders deserve. In closing, Iszo wants to stress that it is a long-term investor - one that is 100% committed to acting as a catalyst for meaningful, value-enhancing change at Nam Tai. We will not be deterred by the Kaisa-controlled Board's groundless attacks or any additional maneuvers it may be planning. IsZo is not going anywhere."

08:06 EDT Immunomedics announces early-stage results with Trodelvy in brain cancers - Immunomedics announced that Trodelvy delivered 150-fold and 40-fold the 50% inhibitory concentration of SN-38 for BMBC and rGBM, respectively, and produced partial responses in both cohorts of brain cancer patients. "These early intracranial responses are very encouraging signs of sacituzumab govitecan's activity in central nervous syste tumors as previously observed in preclinical models,"1 said Andrew J. Brenner, M.D. Ph.D., Clinical Investigator, Institute for Drug Development; Co-Leader, Experimental and Developmental Therapeutics Program; S & B Kolitz/CTRC-Zachry Endowed Chair in Neuro-Oncology Research, Mays Cancer Center at UT Health San Antonio, San Antonio, TX, who reported the results in a mini oral session on CNS tumors at the ESMO Virtual Congress 2020. "With a hydrolysable linker that allows SN-38 to be released at the tumor site and given that SN-38 freely crosses the blood brain barrier and is active in the nanomolar range for most cancer cells, including triple-negative breast cancer and GBM, sacituzumab govitecan has the prerequisite ability to deliver therapeutically relevant concentrations of SN-38 across an undisrupted vasculature. The early clinical results in patients with neoplastic involvement of the brain warrant further development of Trodelvy in these aggressive and lethal cancers." At the time of data cutoff, 19 patientswere enrolled into the study. No new safety signals were observed. Patients with BMBC or rGBM were enrolled into the single center study to receive a single intravenous dose of Trodelvy at 10 mg/kg one day before surgical resection. Tumor and corresponding serum were collected during surgery to measure their levels of SN-38 and its metabolites. Following recovery, patients resumed Trodelvy treatment at 10 mg/kg on days 1 and 8 of 21-day cycles and were assessed for responses by MRI every third cycle using response assessment in neuro-oncology criteria.

08:05 EDT Leidos awarded task order worth up to $89M - Leidos has been awarded a task order by the U.S. Air Force's Installation Contracting Agency. Through this task order, Leidos will support energetics research and development for the Office of the Secretary of Defense and the Combat Capability Development Command - Armament Center. The single award, Cost-Plus-Fixed-Fee task order falls under the Air Force's Information Analysis Center Multiple Award Contract. If fully funded, it holds a total estimated value of $89M.

08:03 EDT Mirati Therapeutics presents Phase 2 sitravatinib/nivolumab data at ESMO - Mirati Therapeutics announced updated clinical results from its Phase 2 study evaluating sitravatinib in combination with nivolumab in patients with advanced or metastatic urothelial carcinoma. Sitravatinib is an investigational multi-targeted tyrosine kinase inhibitor that distinguishes itself by potently targeting the TAM and split family receptors. The combination of sitravatinib with nivolumab demonstrated promising clinical activity in checkpoint inhibitor-naive, platinum-refractory patients. These data were presented today in a mini oral session at the European Society for Medical Oncology Virtual Congress 2020 by Dr. Pavlos Msaouel, M.D., Ph.D. The ongoing, Phase 2, open-label, multicenter trial in patients with advanced or metastatic urothelial carcinoma includes multiple patient cohorts that are defined based on prior therapy and platinum eligibility. Participants in the cohort updated today had been previously treated with platinum-containing chemotherapy but were checkpoint inhibitor naive. As of the data cut-off on July 30, 30 out of 40 patients enrolled in this checkpoint inhibitor-naive, platinum-experienced cohort of the Phase 2 study were evaluable for response: Findings showed an objective response rate of 37%, with 1 patient achieving a complete response and 10 patients achieving a partial response in this high-risk population. 22/30 patients achieved clinical benefit. Secondary efficacy endpoints continue to mature with a median follow-up of 8.7 months. "These data indicate that sitravatinib in combination with nivolumab resulted in a higher overall response rate, as well as longer preliminary progression free survival, when compared to what is generally seen with checkpoint inhibitors or similar tyrosine kinase inhibitor monotherapies in this setting," said Pavlos Msaouel, M.D., Ph.D., Assistant Professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas. "These data continue to show activity of the combination in this tumor setting and further demonstrate the ability of sitravatinib to augment the clinical activity of checkpoint inhibitors. We're pleased by the strength of the combination response, and as the data mature over time, we will continue to evaluate the duration of response."

08:02 EDT Aprea Therapeutics appoints Gregory Wessels to CCO - Aprea Therapeutics (APRE) announced the promotion of Gregory Wessels to the newly created position of chief commercial officer. Wessels joined Aprea in February 2020 from Bristol-Myers Squibb (BMY) where he most recently served as Executive Director - US Marketing for Lymphoma and Acute Myeloid Leukemia. The Company also announced that two of its independent directors, Scott Rocklage, Ph.D. and Jonathan Hepple, Ph.D. have decided to step down after nearly a decade of collective service on the Board. In connection with the departure from the Board of Drs. Rocklage and Hepple, Christian Schade was appointed Chairman of the Board of Directors, John Henneman was named Lead Independent Director, Richard Peters, M.D., Ph.D, became Chairman of the Company's Compensation Committee and Fouad Namouni, M.D. became a member of the Company's Nominating and Corporate Governance Committee.

07:46 EDT CHMP recommends approval of Lilly's baricitinib to treat atopic dermatitis - Eli Lilly and Company (LLY) and Incyte (INCY) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion for baricitinib for the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy. This opinion marks the first step toward European regulatory approval for baricitinib for patients with AD. If approved, baricitinib would become the first JAK inhibitor indicated to help treat patients with AD. The CHMP opinion is now referred for action to the European Commission, which grants approval in the European Union. A final decision is expected from the European Commission in the next one-two months.

07:34 EDT Auxly Cannabis files early warning report - Auxly Cannabis announces pursuant to the requirements of National Instrument 62-103 - The Early Warning System and Related Take-Over Bid and Insider Reporting Issues and applicable Canadian securities legislation that on September 17, 2020, the Company completed a disposition of 6,000,000 common shares and $400,000 worth of convertible debentures of Inner Spirit Holdings for gross proceeds of $845,400, which reduces Auxly's security holding percentage in Inner Spirit from 12.9% to 9.8%. The disposition was completed through the Canadian Securities Exchange where Inner Spirit's common shares and convertible debentures are listed for trading. Since Auxly's security holding percentage of Inner Spirit is now below 10%, following the filing of the early warning report in connection with the disposition, Auxly will no longer file early warning or insider reports in respect of Auxly's ownership of Inner Spirit's securities, except as may be required by applicable law. Following the disposition, Auxly continues to have ownership and control of 19,941,177 common shares, 3,000,000 warrants, and 600,000 options to purchase common shares of Inner Spirit.

07:32 EDT Veru presents results from Phase 1b study of VERU-111 - Veru announced that positive clinical results from its Phase 1b study of VERU-111 were orally presented at the European Society for Medical Oncology Congress 2020. The results of the Phase 1b study evaluating VERU-111, a novel oral microtubule targeting agent that selectively inhibits alpha and beta tubulin, in 39 men with metastatic castration resistant prostate cancer that have also failed at least one androgen receptor targeting agent and a large and growing unmet medical need in advanced prostate cancer, have been presented as an oral presentation by Mark Markowski, MD, Assistant Professor of Oncology from the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center. The oral presentation is entitled "Phase 1b/2 study of VERU-111, novel, oral tubulin inhibitor, in men with metastatic castration resistant prostate cancer who failed an androgen blocking agent. The highlights of the study were as follows: Phase 1b portion of the study enrolled 39 men in 7 clinical sites in the United States and used a two-part dosing schedule with a standard 3+3 dose escalation strategy followed by an expanded dose and dose schedule of VERU-111 daily continuous dosing until disease progression or toxicity. Patient demographics: 44% failed both abiraterone and enzalutamide; 55% had bone only metastatic disease. The Maximum Tolerated Dose of VERU-111 was 72mg. No Grade 3 diarrhea was observed at doses less than72 mg per day. At doses less than 72mg/d, the most common adverse events were mild to moderate nausea, vomiting, diarrhea, and fatigue, with no observed neurotoxicity or neutropenia. Antitumor activity was assessed by PSA as well as bone and CT scans in 10 men that were treated for greater than or equal to 4 continuous 21-day cycles which represents 33% of all men enrolled in the Phase 1b who were chemotherapy naive. 6/10 had PSA declines: 4/10 had greater than or equal to 30% and 2/10 greater than or equal to 50% declines compared to their 21-day cycle baseline. Based on PCWG3/RECIST 1.1 criteria, objective tumor responses were seen in 2/10 and 7/10 had stable disease. Median duration of treatment without radiographic progression was greater than 11+ months as 5/10 men are still on study. Median duration of treatment without progression in all men who received any 63mg oral dosing was 9.8+. For point of reference from the scientific literature, in similar men with mCRPC who have failed at least one androgen receptor targeted agent, the median radiographic progression free survival was 3.6 months on an alternative androgen receptor targeting agent and for men with mCRPC who failed both abiraterone or enzalutamide the radiographic progression free survival was 2.6 months. Phase 2 clinical study has almost completed enrollment of 40 men with mCRPC who have failed at least one androgen blocking agent. In conclusion, the recommended Phase 2 dose is 63mg oral daily continuous dosing for 21-day cycles and daily chronic drug administration is feasible and safe in the Phase 1b study. At the recommended Phase 2 dose, there were no reports of neutropenia, neurotoxicity, or Grade 3 diarrhea. Based on these promising clinical data, VERU met with FDA on the Phase 3 clinical trial design in July 2020. The plan is to submit a final Phase 3 clinical protocol to evaluate VERU-111 in men with mCRPC and who have also failed one androgen receptor targeting agent in the 4th calendar Quarter 2020 and initiate a Phase 3 study in the 1st calendar Quarter 2021.

07:11 EDT Summit Therapeutics completes redomiciliation to Delaware - Summit announces the completion of the company's redomiciliation to Delaware, USA. Previously, Summit Therapeutics plc announced that the High Court of Justice in England and Wales had sanctioned the scheme of arrangement under Part 26 of the Companies Act 2006 pursuant to which Summit Therapeutics Inc. is becoming the new Delaware, USA incorporated holding company of Summit Therapeutics plc and its subsidiaries. Following the delivery today of the Court Order to the Registrar of Companies in the U.K., the Scheme has become effective and every five ordinary shares, GBP 0.01 par value per share, of Summit Therapeutics plc were exchanged for one share of common stock, $0.01 par value per share, of Summit Therapeutics Inc. The entire issued share capital of Summit Therapeutics plc is now owned by Summit Therapeutics. It is expected that the last day of trading in the Summit Therapeutics plc American Depositary Shares on the Nasdaq Global Market will be on September 18, 2020 and trading in the shares of common stock of Summit Therapeutics Inc. on the Nasdaq Global Market will commence on September 21, 2020 under the ticker symbol "SMMT", which was the symbol for the American Depositary Shares of Summit Therapeutics plc. Since the ratio at which the ordinary shares of Summit Therapeutics plc are being exchanged for shares of common stock of Summit Therapeutics Inc. is equal to the ratio of its ordinary shares to the American Depositary Shares, no adjustment to the Nasdaq trading price is being made in connection with the listing of the common stock of Summit Therapeutics Inc.

07:08 EDT Trillium Therapeutics appoints Michael Kamarck to board of directors - Trillium Therapeutics (TRIL) announced the appointment of pharmaceutical industry leader Michael Kamarck, Ph.D., to its Board of Directors, effective immediately. He currently serves as CTO for Vir Biotechnology (VIR) where he manages a multi-modality technical approach to the development of treatments for serious infectious diseases such as COVID-19, influenza and hepatitis B.

07:07 EDT Renalytix AI announces commercial launch of KidneyIntelX test platform - Renalytix AI announces the commercial launch of the KidneyIntelX clinical test reporting platform within the Mount Sinai Health System in New York City. KidneyIntelX risk assessment of progressive decline in kidney function or kidney failure, including education support for treating clinicians, is now commercially available for patients with early stage diabetic kidney disease. In addition to patient testing and risk assessment, a central component of this launch milestone is the physician education and support program developed in close collaboration with leadership of the Mount Sinai Departments of Medicine and Population Health Science and Policy, with input from patient advocacy groups and the broader clinical community. This expert experience is reflected in the design of the KidneyIntelX test report and the newly launched product website - www.kidneyintelx.com. Agreements with Laboratory Corporation of America and a national medical logistics provider were entered into in calendar Q3 to support sample collection at five patient service centers servicing Mount Sinai patients. The Company intends to scale this process with laboratory service providers and logistics providers across multiple territories in the United States to ensure patient blood samples can be efficiently and securely delivered to RenalytixAI laboratories in New York, New York and Salt Lake City, Utah. In June 2020, the Company announced that it received a clinical laboratory permit from the New York State Department of Health to provide commercial testing of KidneyIntelX. The Company is currently licensed to provide testing services for patients in 48 states. With the commercial launch at Mount Sinai, RenalytixAI expects revenue generation to increase in the near-term.

07:05 EDT Achieve Life: Results from cytisinicline vs. chantix study presented at SRNT-E - Achieve Life Sciences announced data presented at the Society for Research on Nicotine and Tobacco European Annual Meeting. The presentation, "Cytisine's Lower Potency at 5-HT3 Receptors May Explain its Lower Incidence of Nausea and Vomiting than Varenicline", provides a rationale based on detailed receptor pharmacology to explain why the incidence of nausea and vomiting associated with cytisinicline appears to be consistently lower than that seen with varenicline. The study, conducted at the University of Cambridge Department of Biochemistry by Professor Sarah Lummis and Dr. Kerry Price, was designed to examine the in vitro binding characteristics of cytisinicline compared to varenicline at the human 5-HT3 receptor. Using a radioligand antagonist displacement design, the study reported an IC50 of 0.50 mM for cytisinicline and 0.25 microM for varenicline, representing a 2000-greater fold agonist binding affinity to the 5-HT3 receptor for varenicline compared to cytisinicline.

07:03 EDT Blackstone announces formation of new portfolio company, ClearGen - Blackstone said in a release, "Blackstone, through funds managed by GSO Capital Partners, announced the formation of a new portfolio company, ClearGen that will finance and own distributed and sustainable energy infrastructure assets focused on commercial, industrial and institutional customers. GSO will initially commit $250 million to fund ClearGen and expects to expand the commitment as capital is deployed. ClearGen will be managed by industry veterans with a combined 55 years of experience, George Plattenburg, Co-Founder and CEO, and Collin Franceschi, Co-Founder and Chief Development Officer. ClearGen and Blackstone will offer flexible capital solutions and programmatic investments alongside equipment manufacturers, developers and energy service companies who develop, build, and operate Distributed Infrastructure. Through these partnerships, ClearGen will invest in a wide range of assets including microgrids, distributed generation, renewable energy combined with battery storage, energy efficiency investments, green transportation, and combined heat and power plants. These assets will serve various sectors, including technology, telecommunications, healthcare, real estate, industrials, and other commercial and industrial energy consumers."

06:58 EDT Takeda Pharmaceutical, Foundation Medicine announce collaboration - Foundation Medicine and Takeda Pharmaceuticals USA announced a collaboration for the development of Foundation Medicine's tissue- and blood-based companion diagnostics for use with marketed and investigational treatments in Takeda's late-stage lung cancer portfolio. If approved, the appropriate companion diagnostics would be used to identify patients who may be eligible for mobocertinib, an investigational drug being evaluated for the treatment of patients with epidermal growth factor receptor Exon20 insertion+ metastatic non-small cell lung cancer, and ALUNBRIG, Takeda's tyrosine kinase inhibitor recently FDA-approved to treat patients with TKI-naive anaplastic lymphoma kinase-positive mNSCLC.

06:54 EDT Piedmont Lithium trading halted, news pending

06:50 EDT Merck, AZN announce 'positive' five-year follow-up data from Phase 3 SOLO-1 - AstraZeneca (AZN) and Merck (MRK) announced positive five-year follow-up data from the Phase 3 SOLO-1 trial which demonstrated a long-term progression-free survival benefit of LYNPARZA versus placebo as a first-line maintenance treatment in patients with newly diagnosed, advanced BRCA-mutated ovarian cancer who were in complete or partial response to platinum-based chemotherapy. Five-year follow-up data from the Phase 3 SOLO-1 trial showed LYNPARZA reduced the risk of disease progression or death by 67%, and improved median PFS to 56 months vs. 13.8 months for placebo. At five years, 48.3% of patients treated with LYNPARZA remained free from disease progression vs. 20.5% on placebo. The median duration of treatment with LYNPARZA was 24.6 months vs. 13.9 months with placebo. Median follow-up in the LYNPARZA arm was 4.8 years and 5 years for placebo.

06:42 EDT AstraZeneca reports Lynparza PFS benefit vs. placebo during ESMO presentation - AstraZeneca (AZN) and Merck's (MRK) Lynparza demonstrated a long-term progression-free survival, or PFS, benefit versus placebo as a 1st-line maintenance treatment in patients with newly diagnosed, advanced BRCA-mutated, or BRCAm, ovarian cancer who had a complete or partial response following platinum-based chemotherapy. Five-year follow-up data from the SOLO-1 Phase III trial showed Lynparza reduced the risk of disease progression or death by 67% and improved PFS to a median of 56 months versus 13.8 months for placebo. At five years, 48.3% of patients treated with Lynparza remained free from disease progression versus 20.5% on placebo. The median duration of treatment with Lynparza was 24.6 months versus 13.9 months with placebo. The safety profile of Lynparza was consistent with previous observations. The most common adverse events, or AEs, greater than or equal to 20% were nausea, fatigue/asthenia, vomiting, anaemia and diarrhoea. The most common greater than or equal to grade 3 AEs were anaemia and neutropenia. Overall, 12% of patients on Lynparza discontinued treatment due to an AE. The results were presented on during the 2020 European Society of Medical Oncology, or ESMO, virtual congress. The SOLO-1 Phase III trial met the primary endpoint of PFS in June 2018, which formed the basis of approvals in the US, the EU, Japan, China and several other countries.

06:35 EDT AstraZeneca presents updated Imfinzi results from PACIFIC trial at ESMO - Updated results from the PACIFIC Phase III trial showed AstraZeneca's Imfinzi demonstrated a sustained, clinically meaningful overall survival, or OS, and progression-free survival, or PFS, benefit in patients with unresectable, Stage III non-small cell lung cancer, or NSCLC, who had not progressed following concurrent chemoradiation therapy, or CRT. One in three patients with NSCLC are diagnosed at Stage III, where the majority of tumours are unresectable. Prior to the approval of Imfinzi in this setting, no new treatments beyond CRT had been available to these patients for decades. The results from the updated post-hoc analyses showed an estimated four-year overall survival rate of 49.6% for Imfinzi versus 36.3% for placebo after CRT. Median OS was 47.5 months for Imfinzi versus 29.1 for placebo. With a maximum treatment course of one year, an estimated 35.3% of patients treated with Imfinzi had not progressed four years after enrolment versus 19.5% for placebo. These data build on The New England Journal of Medicine publication from 2018 demonstrating a benefit for Imfinzi in the OS primary endpoint. In the primary OS analysis of the PACIFIC Phase III trial, the most common adverse events, or AE, among patients treated with Imfinzi versus placebo were cough, fatigue, dyspnoea and radiation pneumonitis. A grade 3 or 4 AE was experienced by 30.5% of patients treated with Imfinzi versus 26.1% for placebo, and 15.4% of patients discontinued treatment due to AEs with Imfinzi versus 9.8% for placebo. New exploratory subgroup analyses from the CASPIAN Phase III trial of Imfinzi were conducted to characterise patients deriving long-term benefit. More than three times as many patients treated with Imfinzi plus chemotherapy were alive and progression free for one year or more versus chemotherapy alone. Across all treatment arms, the subgroup of patients who were progression free at one year had a 75% chance of being alive at two years. In comparison, the subgroup of patients whose disease had progressed within one year had a 10% chance of being alive at two years. Clinical characteristics did not appear to identify patients who derived long-term benefit. Patients with PFS greater than or equal to 12 months received more cycles of Imfinzi treatment compared to patients with PFS less than12 months. Although patients with greater exposure to Imfinzi had numerically higher rates of immune-mediated AEs, the two subgroups had similar rates of severe AEs, serious AEs and AEs leading to discontinuation. The CASPIAN trial met the primary endpoint of OS in 2019, reducing the risk of death by 27% in patients with ES-SCLC treated with Imfinzi plus a choice of chemotherapy versus chemotherapy alone. The safety and tolerability of Imfinzi plus chemotherapy were consistent with the known safety profiles of these medicines. These results were published in The Lancet in 2019 and formed the basis of regulatory approvals around the world. Results from the PACIFIC and CASPIAN Phase III trials were presented during the ESMO Virtual Congress.

06:31 EDT SpringsWorks Therapeutics enters research agreement with Fred Hutch - SpringWorks Therapeutics announced that it has entered into a sponsored research agreement with Fred Hutchinson Cancer Research Center to further explore the ability of SpringWorks' investigational gamma secretase inhibitor, nirogacestat, to modulate B-cell maturation antigen and potentiate BCMA-targeting therapies, including radioimmunotherapies, in a variety of preclinical and patient-derived multiple myeloma models developed by researchers at Fred Hutch. Damian Green, M.D., Associate Member of the Clinical Research Division at Fred Hutch and Associate Professor at the University of Washington School of Medicine, will serve as the Principal Investigator for this research.

06:07 EDT PG&E CFO Jason Wells resigns to become CFO of another utility - In a regulatory filing, PG&E said that on September 14, Jason P. Wells, Executive Vice President and CFO, informed PG&E that he is resigning from his positions effective September 25, 2020, to become the CFO of another investor owned utility. Wells' resignation does not involve any disagreement on any matter relating to PG&E's operations, policies or practices, the company said in the filing.

06:02 EDT Incyte says retifanlimab 'generally well-tolerated' in Phase 2 trial - Incyte announced results from its Phase 2 POD1UM-202 trial evaluating retifanlimab, a PD-1 inhibitor, in previously treated patients with advanced squamous cell carcinoma of the anal canal who have progressed following standard platinum-based chemotherapy. The trial enrolled 94 patients, including those with well-controlled human immunodeficiency virus infection. Retifanlimab monotherapy resulted in a confirmed objective response rate of 14% as determined by independent central review using RECIST v1.1. Responses were observed regardless of PD-L1 status, presence of liver metastases, age or HIV+ status. Retifanlimab was generally well-tolerated with a safety profile as expected of a PD-1 inhibitor and no loss of HIV infection control. "The results from the POD1UM-202 trial highlight the potential of retifanlimab to provide a meaningful treatment for patients with SCAC who have progressed following standard platinum-based chemotherapy and therefore have a very poor prognosis," said Lance Leopold, M.D., Group Vice President, Immuno-Oncology Clinical Development, Incyte. "These data are especially important because this trial enrolled HIV+ patients who are at the greatest risk of developing SCAC and are typically systematically excluded from oncology clinical trials."

05:53 EDT Genentech announces Phase III EMPACTA study met primary endpoint - Genentech, a member of the Roche Group, announced that the Phase III EMPACTA study met its primary endpoint, showing that patients with COVID-19 associated pneumonia who received Actemra plus standard of care were 44% less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard of care. Genentech said in a release, "The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra arm versus 19.3% in the placebo arm. The EMPACTA study did not identify any new safety signals for Actemra. The study is the first global, Phase III COVID-19 clinical trial to primarily enroll patient populations that are often underrepresented in clinical studies and have been disproportionately affected by the COVID-19 pandemic. Approximately 85% of the 389 patients were from minority racial and ethnic groups. The majority of patients were Hispanic, with significant representation of Native American and Black or African American populations. The trial was conducted in the United States, South Africa, Kenya, Brazil, Mexico and Peru. Results from the EMPACTA trial will be submitted for publication in a peer-reviewed journal. Actemra is currently being investigated as a potential treatment for COVID-19 associated pneumonia, including in combination with an anti-viral in the Phase III REMDACTA clinical trial. Results from the Phase III COVACTA trial in patients with severe COVID-19 associated pneumonia were released in July. In addition, there are a number of independent trials of Actemra in this setting. Actemra has not been approved by any health authority for COVID-19 associated pneumonia."

05:32 EDT NetEase announces ADS ratio change of five-for-one - NetEase announced that it will change the ratio of its American depositary shares, or ADSs, representing ordinary shares, from the current one ADS for every twenty-five ordinary shares to one ADS for every five ordinary shares. From the perspective of an ADS holder, the ADS ratio change has the same effect as a five-for-one ADS split, and NetEase ADS holders at the close of business, New York time, on September 30 will be entitled to receive four additional ADSs for every ADS held, effective October 1 at the close of business. There will be no change to NetEase's ordinary shares, and no action by ADS holders is required to effect the ratio change. In addition, existing ADSs will continue to be valid and will not have to be exchanged for new ADSs. The effect of the ratio change on the ADS trading price on the Nasdaq Global Select Market is expected to take place on October 2.

05:20 EDT Pfizer, EMD Serono announce publication of JAVELIN Bladder 100 study results - EMD Serono and Pfizer announced the publication of detailed results from the Phase III JAVELIN Bladder 100 study online ahead of print in The New England Journal of Medicine. These results were published simultaneously with additional analyses being presented at the European Society for Medical Oncology, or ESMO, virtual congress 2020 and describe the efficacy of Bavencio as a first-line maintenance treatment across various subgroups of patients with locally advanced or metastatic urothelial carcinoma, or UC, and highlight exploratory biomarkers as well as patient-reported outcomes. In June, the FDA approved Bavencio for the maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy based on the JAVELIN Bladder 100 results. In the JAVELIN Bladder 100 study, Bavencio plus best supportive care, or BSC, significantly extended overall survival, or OS, compared with BSC alone in the two primary populations of all randomized patients and patients whose tumors were PD-L1+ and significantly more patients who received Bavencio as first-line maintenance were alive at one year. The clinical benefits of Bavencio were seen across a range of patient populations. In the JAVELIN Bladder 100 study, OS was significantly longer with Bavencio plus BSC compared to BSC alone in the primary population of all randomized patients whose disease had not progressed on first-line platinum-containing chemotherapy. Median OS was 21.4 months vs 14.3 months, respectively. At one year, 71.3% of patients in the Bavencio arm were alive vs 58.4% of patients who received BSC alone. In the other primary population of patients with PD-L1+ tumors OS was also significantly longer with Bavencio plus BSC vs BSC alone. At one year, 79.1% of patients who received Bavencio were alive vs 60.4% in the BSC arm. All endpoints were measured from the time of randomization, after completion of four to six cycles of chemotherapy. Results of an exploratory subgroup analysis show that consistent results were observed with the JAVELIN Bladder regimen of Bavencio first-line maintenance across pre-specified subgroups, including best response to first-line chemotherapy, type of chemotherapy regimen, site of baseline metastasis, and other baseline factors.1 In particular, hazard ratios for OS based on response to first-line chemotherapy were as follows: 0.69 for complete or partial response and 0.70 for stable disease. With regard to first-line chemotherapy regimen, hazard ratios were as follows: 0.69 with gemcitabine plus cisplatin and 0.66 with gemcitabine plus carboplatin. Further detail from the subgroup analysis were presented in an on-demand mini oral session at the meeting. Additional data evaluating the association between clinical outcomes and exploratory biomarkers will be presented in the Proffered Paper 1 - GU, non prostate session on Saturday, September 19 and patient-reported outcomes are featured in an on-demand e-poster display.

05:19 EDT Regeneron, Sanofi present 'positive' data for Libtayo monotherapy in BCC - Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced the presentation of positive results from the pivotal Phase 2 trial for the PD-1 inhibitor Libtayo in patients with locally advanced basal cell carcinoma, or BCC, who had progressed on or were intolerant to hedgehog inhibitor, or HHI, therapy. The companies said in a release, "The data were shared in a late-breaking presentation at the European Society for Medical Oncology or ESMO, Virtual Congress 2020, and form the basis of regulatory submissions, including in the U.S. and European Union. Per independent central review, the objective response rate, or ORR, was 31% among Libtayo-treated patients, with a median follow-up of 15 months (range: 1-25 months). This included a 6% complete and 25% partial response rate. This is an increase from the ORR shared in May and includes two responses that were confirmed after the initial data analysis. Responses were seen regardless of baseline PD-L1 expression in tumor cells. As of data cut-off, the median duration of response and median overall survival had not yet been reached. At one-year, 85% of responses were ongoing, the probability of progression-free survival was 57%, and the probability of overall survival was 92%, according to Kaplan-Meier estimates. No new Libtayo safety signals were observed. The most common treatment-related adverse events, or AEs, were fatigue, pruritus and asthenia. Grade 3 or higher treatment-related AEs that occurred in at least 2 patients were colitis, fatigue and adrenal insufficiency. Fourteen patients discontinued treatment due to treatment-emergent AEs. Libtayo was invented using Regeneron's VelocImmune technology that utilizes a proprietary genetically-engineered mouse platform endowed with a genetically-humanized immune system to produce optimized fully-human antibodies. VelocImmune technology has been used to create multiple antibodies including Dupixent (dupilumab), Praluent (alirocumab) and Kevzara (sarilumab), which are approved in multiple countries around the world. Regeneron previously used these technologies to rapidly develop a treatment for Ebola virus infection, which is currently under review by the FDA, and to create REGN-COV2, a potentially preventative and therapeutic medicine for COVID-19. Libtayo is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. The use of Libtayo to treat advanced BCC is investigational and has not been fully evaluated by any regulatory authority."