Stockwinners Market Radar for April 16, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:41 EDT QuantumScape CEO: We pride ourselves on our transparency - In an interview on CNBC's Mad Money, Jagdeep Singh said QuantumScape has always been transparent about its data and about work that still needs to be done. "We're confident that the numbers we have are groundbreaking," he added. Singh noted that QuantumScape's core people have been with company for ten years and are not simply looking to make fast money. "They're a long-term committed team on a mission," he said. When asked about Scorpion Capital's allegations, he claimed that some of their points are "absurd."

17:16 EDT BlackRock senior managing director Wiedman sells 1,725 common shares - In a regulatory filing, BlackRock senior managing director Mark Wiedman disclosed the sale of 1,725 common shares of the company on April 16 at a price of $812.5268 per share.

17:05 EDT Afya acquires Cliquefarma for R$19M - Afya announced the acquisition of 100% of the total share capital of Cliquefarma, a healthtech company operating a free-to-use website that tracks prescription drugs, cosmetics and personal hygiene product prices in Brazil. Users of Cliquefarma can search for medications or healthcare products and compare prices from over 5,000 pharmacies in Brazil. The traffic generated is monetized through a cost-per-click model, where drugstores pay for each click on their ads. In 2020 Cliquefarma generated traffic of 20M visitors and R$43.2M in gross merchandise volume, the latter representing a 52.9% growth compared to 2019. The aggregate purchase price is R$19M of which 84.2% paid in cash and 15.8% is paid in Afya stocks as the date hereof. An earn-out of R$3M can be paid related to product development. This aggregate purchase price is equivalent to a 4.1x gross revenue multiple for 2021 expected gross revenue.

16:46 EDT FDA revokes emergency use authorization for Eli Lilly's bamlanivimab - The U.S. FDA revoked the emergency use authorization that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone resulting in the increased risk for treatment failure, the FDA has determined that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks for its authorized use. Therefore, the agency determined that the criteria for issuance of an authorization are no longer met and has revoked the EUA. Reference Link

16:44 EDT Oak Street Health CMO sells 109.4K shares of common stock - In a regulatory filing, Oak Street Health disclosed that its Chief Medical Officer Griffin Myers sold 109.4K shares of common stock on April 15th in a total transaction size of $6.28M, reducing his stake by about 2%.

16:43 EDT PPD CEO sells 100K shares of common stock - In a regulatory filing, PPD disclosed that its CEO David Simmons sold 100K shares of common stock on April 14th in a total transaction size of $4.2M, reducing his stake by about 7%.

16:17 EDT Hartford Financial to pay $650M settlement to Boy Scouts of America - Hartford Financial announced that it has entered into a settlement agreement and release with the national organization of the Boy Scouts of America, or BSA, pursuant to which The Hartford will pay $650M, before tax, for sexual abuse claims associated with policies mostly issued in the 1970s. The agreement, entered into after extensive negotiations, contemplates that, in exchange for The Hartford's payment, the BSA and its local councils will fully release The Hartford from any obligation under policies it issued to the BSA and its local councils. The agreement is in connection with BSA's Chapter 11 bankruptcy and will become effective upon the occurrence of certain conditions, including confirmation of the BSA's global resolution plan, executed releases from the local councils, and approval from the abuse claimants and bankruptcy court. The Hartford and the BSA hope to receive court approval in Q3, but this could be delayed for various procedural reasons. The Hartford estimates unfavorable prior year development of approximately $225M, before tax, in Q1 that includes, among other items, a charge to increase reserves for the BSA settlement above the amount previously reserved for this exposure. The Hartford also estimates current accident year catastrophe losses, net of reinsurance, of approximately $214M, before tax, including approximately $176M, before tax, from February winter storms in Texas and other areas. The Hartford is pre-releasing certain preliminary financial information for its 2021 first quarter, including estimated current accident year catastrophe losses and prior year reserve development. Such preliminary financial information reflects estimates and is subject, among other things, to the completion of The Hartford's quarter-end financial closing processes.

16:11 EDT Commercial Vehicle Group terminates rights agreement - CVG announced that its Board of Directors unanimously approved the termination of the company's rights agreement, commonly referred to as a "poison pill", which was originally scheduled to expire on June 24. The rights agreement was amended to accelerate the expiration date to April 15, effectively terminating the rights agreement as of that date. "CVG is committed to enhancing its governance policies for the benefit of stockholders," said Harold Bevis, President and CEO of CVG. "The termination of the rights agreement advances that objective."

16:08 EDT Citizens granted regulatory approval to purchase Class B shares - Citizens, Inc. announced that on April 12, 2021, final regulatory approval was granted, enabling the Harold E. Riley Foundation to transfer all of the Class B common stock back to Citizens, Inc. As previously disclosed, on February 5, 2021, Citizens, Inc. entered into a Purchase and Sale Agreement with the Foundation to purchase 100% of the company's Class B common stock from the Foundation at an aggregate purchase price of $9,090,463.80 which was paid on March 5, 2021. J.D. "Chip" Davis, Jr., Chairman of the Board, said, " This is a tremendous milestone and essential turning point in the Company's history. For the first time in more than 30 years, we are not a controlled company. With Citizens regaining control, the Company and Board of Directors can chart its own course and act in the best interest of all shareholders."

16:06 EDT CRH Medical shareholders approve acquisition by WELL Health - CRH Medical announced that its securityholders approved the acquisition of CRH by a subsidiary of WELL Health Technologies at the special meeting of CRH securityholders. Subject to the satisfaction of such conditions, the transaction is expected to be completed on or about April 22.

16:01 EDT HarborOne Bancorp announces 2,790,903 share repurchase program - HarborOne Bancorp announced that its Board of Directors has adopted a share repurchase program. Under the share repurchase program, which is subject to regulatory approval, the company may repurchase up to 2,790,903 shares of the company's common stock, or approximately 5% of the company's issued and outstanding shares as of March 31.

15:56 EDT Curis granted orphan status for myelodysplastic syndrome treatment - The FDA granted Curis orphan status for its treatment of myelodysplastic syndrome. Reference Link

14:57 EDT Value Line raises quarterly dividend 4.8% to 22c from 21c per share - Payable on May 11 to stockholders of record on April 26.

14:25 EDT J&J sees no 'causal relationship' between Covid vaccine and blood clots - Three Johnson & Johnson employees involved in vaccine development and epidemiology told the New England Journal of Medicine, "At this time, evidence is insufficient to establish a causal relationship between these events and the Ad26.COV2.S vaccine." Reference Link

13:28 EDT Capital Returns: ISS recommends FBL Financial investors vote against merger - Capital Returns Management, LLC, beneficial owner of 147,752 shares of Class A common stock of FBL Financial Group, issued the following statement welcoming the recommendation from proxy advisory firm ISS that shareholders vote AGAINST the proposed merger of FBL with Farm Bureau Financial Property & Casualty Insurance Company: "We are pleased that ISS is recommending that shareholders vote against this deal. The proposed merger materially undervalues FBL and was the result of a flawed process rife with conflicts of interest. The $56 price is grossly inadequate and fails to reflect FBL's strategic importance to FBPCIC. Given the significant appreciation in life insurance company valuations since the time of the negotiation, the deal offers no real premium to FBL shareholders and there is limited downside risk when shareholders reject this low-ball offer." In its report, ISS concluded: "Given the suboptimal process, uncompelling valuation, and low downside risk of non-approval, the standalone scenario appears to be a more attractive alternative to the offer. As such, shareholders are recommended to vote against the proposed transaction under the current terms."

13:13 EDT Bristol-Myers confirms FDA approves Opdivo combo for gastric cancer - Bristol Myers Squibb announced that Opdivo, in combination with fluoropyrimidine- and platinum-containing chemotherapy, was approved by the U.S. Food and Drug Administration for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma, regardless of PD-L1 expression status. Opdivo is associated with the following Warnings and Precautions: severe and fatal immune-mediated adverse reactions including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, nephritis and renal dysfunction, dermatologic adverse reactions, other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation; embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo is added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials. "We are focused on bringing transformative medicines to patients in need, and historically, there has been little progress for patients diagnosed with these metastatic gastroesophageal adenocarcinomas. As demonstrated in the CheckMate -649 trial, Opdivo is the first and only immunotherapy combined with chemotherapy to deliver superior overall survival versus chemotherapy alone in first-line metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma," said Adam Lenkowsky, general manager and head, U.S., Oncology, Immunology, Cardiovascular, Bristol Myers Squibb.

13:06 EDT Baker Hughes reports U.S. rig count up 7 to 439 rigs

12:36 EDT U.S. exceeds 200M COVID-19 vaccine doses administered - White House COVID-19 data director Cyrus Shahpar said on Twitter that 3.97M more COVID-19 vaccine doses have been administered over yesterday's total at a rate that is "steady" with the prior two Fridays. "Overall a great day as we head toward 100% of states with universal eligibility for 16 and over, by Monday," Shahpar said. The Fly notes that the added administrations brings the U.S. to over 200M total vaccine shots administered. The U.S. has so far approved COVID-19 vaccines from Pfizer (PFE) and BioNTech (BNTX), and Moderna (MRNA), while the administration of Johnson & Johnson's (JNJ) vaccine has been paused amid blood clotting concerns. Reference Link

12:32 EDT Akers Biosciences announces stockholder approval for MyMD merger - Akers Biosciences and MyMD Pharmaceuticals announced that at Akers' special meeting of stockholders held on April 15, 2021, Akers obtained sufficient votes for each proposal required to consummate the previously announced proposed merger between Akers and MYMD. MYMD previously obtained a sufficient number of written consents from its stockholders to consummate the merger. Upon closing, the combined company will be named MyMD Pharmaceuticals, Inc. and will remain listed on the Nasdaq under the new ticker symbol "MYMD," beginning April 19, 2021. The company intends to focus on developing and commercializing novel immunotherapy pipeline assets, including MYMD-1, a first-in-class drug being developed to treat autoimmune and age-related diseases, including extending the human lifespan.

12:18 EDT CoreCivic trading halted, news pending

12:04 EDT User reports indicate issues at Google, Gmail, DownDetector says - Reference Link

12:00 EDT First High-School Education falls -8.0% - First High-School Education is down -8.0%, or -56c to $6.40.

12:00 EDT GigCapital3 falls -8.9% - GigCapital3 is down -8.9%, or -90c to $9.17.

12:00 EDT China Green rises 10.6% - China Green is up 10.6%, or $1.15 to $12.00.

11:56 EDT FDA approves Bristol-Myers' Opdivo for initial treatment of gastric cancer - The U.S. Food and Drug Administration approved Opdivo, in combination with certain types of chemotherapy, for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. "This is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer," the FDA said. Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research, added, "Today's approval is the first treatment in more than a decade to show a survival benefit for patients with advanced or metastatic gastric cancer who are being treated for the first time. The FDA is committed to bringing new safe and effective treatment options like Opdivo to patients with advanced cancer." The FDA granted approval to Bristol-Myers Squibb.

11:02 EDT LifeMD says Culper Research report contains 'numerous errors, distortions' - LifeMD released a letter to shareholders in response to an "research note" published by an entity called Culper Research. Culper is an anonymous short-seller that refuses to disclose the individuals or entities behind it. "CEO Justin Schreiber and the company's CTO Stefan Galluppi jointly issued an open letter to shareholders on the company's website, in which they addressed Culper's allegations in detail. The company said, "It identifies numerous errors and basic problems with the report's credibility, including: Culper distorts Galluppi's and Schreiber's relationship with Redwood Scientific. Schreiber held a passive investment and non-controlling interest in the company, and Galluppi left the company two and a half years before it was investigated by the Federal Trade Commission. Culper lies about LifeMD's licensing practices. LifeMD takes the utmost care in creating an environment that fosters the highest standard of care for our patients. LifeMD's physician network consists of nearly 90 board-certified and monitored doctors who legally dispense prescription medications; LifeMD has never allowed an unlicensed physician to perform a telehealth consult for any of its brands. In the rare instance we discover that one of the doctors in our network has a regulatory issue, we remove that doctor immediately - as we did in the case of Dr. Badii. In the case of Dr. Kalter, he was mistakenly described as a California physician on our website. When we became aware of the web design error, we fixed it immediately. Dr. Kalter never wrote a single prescription for us in California. Culper misrepresents the facts about Veritas MD, the platform we used for ~25% of all telehealth consults in Q1 and expect to be using for 100% of consults by the end of Q2. Apparently under the misimpression it was intended to be a consumer-facing app, Culper fails to understand it is our technological backbone, driving the complete and full lifecycle of patient engagement. This process extends from patient intake, patient queries and follow-ups, doctor engagement, and pharmacy services to billing. Everything we have disclosed about our LifeMD digital health platform, also known as VeritasMD, is accurate."

10:51 EDT New 'Monster Hunter: Rise' was March's 2nd best-selling game in U.S., says NPD - NPD analyst Mat Piscatella said that Activision's (ATVI) "Call of Duty: Black Ops Cold War" returned to the top of the U.S. monthly best-sellers chart in March. "Call of Duty: Black Ops Cold War" was also the best-selling title of both the first quarter as well as the 12-month period ending March. Capcom's (CCOEY) "Monster Hunter: Rise" debuted as March's 2nd best-seller, while also ranking 1st on Nintendo Switch (NTDOY). With just one month on the market, lifetime dollar sales of "Monster Hunter: Rise" rank 2nd amongst all Monster Hunter franchise releases, trailing only "Monster Hunter: World." Square Enix's (SQNXF) "Outriders" launched as the 3rd best-selling game of March, Piscatella added. Outriders ranked as the #3 best-selling game on both Xbox (MSFT) and PlayStation (SNE) platforms. Nintendo's "Mario Kart 8: placed 6th on the March 2021 best-sellers chart. "Mario Kart 8" is the best-selling racing genre video game in U.S. history, the analyst noted. The March launch of the Switch version of Activision's "Crash Bandicoot 4: It's About Time" helped the title rise to #15 on the March best-sellers chart after placing 65th in February. Other publicly traded companies in the video game space include Tencent (TCEHY), Ubisoft (UBSFY), Electronic Arts (EA), and Take-Two (TTWO). Reference Link

10:43 EDT Video game spending grew 18% y/y to $5.6B in March, says NPD - NPD analyst Mat Piscatella said that March 2021 consumer spending across video game hardware, content, and accessories reached a March record $5.6B, 18% higher when compared to a year ago. First quarter consumer spending totaled $14.9B, 30% higher than 2020's first quarter. Monthly sales are now comparable to year ago periods that were impacted by pandemic-driven consumer spending increases. March 2021 gains in hardware, accessory and content sales, particularly Mobile, pushed the market to growth despite the elevated comp. March video game hardware dollar sales were 47% higher than a year ago, at a March record $680M. The previous high of $552M was set in March 2008. Year-to-date hardware spending totaled $1.4B, an increase of 81% compared to a year ago. The Nintendo Switch (NTDOY) was the best-selling hardware platform in both units and dollars during the month of March. In the first quarter, Nintendo Switch was the unit sales leader while PlayStation 5 (SNE) ranked first in hardware dollar sales. The PlayStation 5 is the fastest selling console in U.S. history in both unit and dollar sales in terms of lifetime sales with five months on the market. Other publicly traded companies in the space include Activision Blizzard (ATVI), Electronic Arts (EA), GameStop (GME), Microsoft (MSFT), Take-Two (TTWO), Tencent (TCEHY), and Ubisoft (UBSFY). Reference Link

10:27 EDT State Street sees NII $460M-$465M per quarter from here in 2021

10:26 EDT State Street sees fee revenues up 2%-3% y/y in Q2

10:21 EDT Square Enix denies Bloomberg report of interest from buyers - Square Enix, the video game publisher that makes games in the "Final Fantasy," "Dragon Quest," and "Tomb Raider" franchises, released the following statement: "Bloomberg has reported today that there is interest from several buyers to acquire Square Enix. However, this report is not based on any announcement by SQUARE ENIX HOLDINGS CO., LTD. We do not consider selling off the company or any part of its businesses, nor have we received any offer from any third party to acquire the company or any part of its businesses." Other publicly traded companies in the space include Activision Blizzard (ATVI), Electronic Arts (EA), GameStop (GME), Nintendo (NTDOY), Take-Two (TTWO) and Ubisoft (UBSFY). Reference Link

10:18 EDT State Street: Board has authorized up to $425M of common stock buybacks - Comments taken from Q1 earnings conference call.

10:05 EDT AIkido Pharma notes 'positive' early results from PSMA 617-Lu177 study - AIkido Pharma (AIKI) noted that a recent study announced "positive" early results from a PSMA 617-Lu177 study conducted by a global pharmaceutical company. Anthony Hayes, CEO of AIkido Pharma, stated, "As a rising tide lifts all boats, these results indicate the strength of our prior investment in this technology field. These early reports indicate there is strong evidence that developing radioligand therapies have the potential to be an alternative cancer treatment and provide positive outcomes for patients with advanced prostate cancer. The Company's stock price has been down recently, but we believe these positive results from the Novartis (NVS) Phase III study provides an incremental proof point that reinforces our confidence in the radiopharmaceutical space, PSMA and our investment in this technology. With testing data for our technology expected in Q2 of this year, we are excited about the results and the advancement of this technology."

10:00 EDT SOS Limited falls -6.8% - SOS Limited is down -6.8%, or -31c to $4.22.

10:00 EDT 500.com falls -12.2% - 500.com is down -12.2%, or -$1.93 to $13.84.

10:00 EDT Concord Medical rises 9.0% - Concord Medical is up 9.0%, or 33c to $4.00.

09:59 EDT Alibaba says new measures 'lower barriers' for merchants on Tmall and Taobao - Alibaba Group has announced a new set of measures it said will "benefit merchants and sellers on its online marketplaces, Tmall and Taobao, reducing costs and providing comprehensive support to lower entry barriers for those looking to join the platforms." Alibaba Group Chairman and CEO Daniel Zhang said in a call with investors this week that "ongoing technological improvements and upgrades have enabled the company to expand its portfolio of sophisticated services, offering them for free or at lower costs than before to merchants and partners," the company stated. Alibaba has said it will invest more in merchants' training and optimize their back-end workstations to improve operational efficiency. "In addition, the company has earmarked billions of RMB in additional annual spending to support merchants in the coming years," Alibaba said. Reference Link

09:47 EDT SOS Limited falls -8.2% - SOS Limited is down -8.2%, or -37c to $4.16.

09:47 EDT Wipro rises 5.9% - Wipro is up 5.9%, or 39c to $6.95.

09:47 EDT PPG rises 10.4% - PPG is up 10.4%, or $15.95 to $169.92.

09:36 EDT Morgan Stanley says 'very active' in recruiting advisors - Says gaining market share across all businesses. Says long term target is $10T AUM.

09:11 EDT Morgan Stanley expects net interest income to grow from current levels - Says getting "nice tailwind" from loan growth. Says "cauterized" Archegos wound. Says family office disclosures need to be examined. Sees more family office scrutiny post-Archegos. Says did not disclose Archegos because company was having a record quarter.

09:07 EDT Neovasc says Tiara TA unable to receive CE Mark under current MDD regulations - Neovasc announced that the Tiara Transapical system will be unable to receive a European CE mark under the current Medical Device Directive regulations ending on May 26, 2021. The Company is collaborating with its European Notified Body on potential next steps. Neovasc has been working with its Notified Body for more than a year to obtain a decision on a CE Mark for Tiara TA, including an ongoing exchange of additional information beyond the original submission. The Company has determined that it will be unable to provide the additional information required by the Notified Body, which includes further testing data, before the current MDD regulations end next month. The MDD is set to be replaced by the newer Medical Device Regulation on May 26, 2021. A CE Mark under either the MDD or MDR regulations would allow the Company to commercialize the Tiara TA system in Europe. The Company expects to provide an update at, or around, the upcoming Q1 2021 Earnings Call scheduled for early May. The transition from MDD to MDR does not impact the Tiara transfemoral program. The Company has always anticipated that Tiara TF's CE Mark submission would be assessed under MDR.

09:04 EDT Castor Maritime announces $14.8M vessel acquisition - Castor Maritime announces that it entered, through a separate wholly-owned subsidiary, into an agreement to acquire a 2005 Korean-built Aframax tanker from an unaffiliated third-party for a purchase price of $14.8M. The acquisition is expected to be consummated by taking delivery of the vessel within the second quarter of this year and is subject to the satisfaction of certain customary closing conditions. "We are pleased to announce our tenth vessel acquisition in 2021 with the addition of an Aframax tanker, to Castor's fleet. Upon completion of all our recently announced acquisitions, our fleet will consist of sixteen vessels," said Petros Panagiotidis, CEO of Castor.

09:03 EDT TEN, Ltd. announces 24-month, $40M charter for four panamax tankers - TEN announced 24-month charters with profit sharing provisions for four LR1 product tankers to an oil concern. The combined minimum revenues from these contracts are expected to be around $40M, excluding any additional revenue that may be generated from profit-sharing. "These charters highlight our policy of flexible long-term contracts with first-class counterparties that on the one hand provide cash flow security while on the other preserve the Company's ability to capture market upturns in strong freight environments," George Saroglou, COO of TEN commented. "These contracts are a reflection of strong industry fundamentals as world economies restart and mirror the ones currently in evidence in the container and dry bulk sectors."

09:02 EDT Caterpillar announces retirement of two members of board directors - Caterpillar is announcing the retirement of two long-time members of the board of directors, Juan Gallardo and William Osborn. The company also announces the election of Cargill Board Chair and CEO David MacLennan to the board. All changes were effective April 14. MacLennan joins 10 other members on Caterpillar's board of directors and will serve on the Audit Committee.

08:56 EDT Armor All announces global partnership with Red Bull Racing Honda - Armor All announced a global, multi-year partnership with Red Bull Racing Honda, the four-time Formula 1 World Champion team. As the auto cleaning & care partner of Red Bull Racing Honda, Armor All will leverage the partnership to expand its international marketing efforts, grow brand awareness and connect with new consumers. Armor All will also collaborate with Red Bull Racing to explore opportunities surrounding the development of new products. The partnership will also extend to stores wherever Armor All products are sold as well as consumer promotions that will offer fans opportunities to have a full race experience.

08:44 EDT Horizon Therapeutics announces new Uplizna data at AAN - Horizon Therapeutics announced new Uplizna data being presented at the American Academy of Neurology, including new, end-of-study data from the open-label extension period of the pivotal N-MOmentum trial in patients with NMOSD. Uplizna is the first and only FDA-approved anti-CD19 B-cell depleting humanized monoclonal antibody for the treatment of adult patients with anti-aquaporin-4, or AQP4, antibody positive NMOSD. The N-MOmentum Phase 2/3 clinical trial consisted of a 28-week randomized controlled period, or RCP, where study participants received Uplizna or placebo. Following the completion of this period, patients could enter into the OLP for at least two years, during which all patients received Uplizna 300 mg every six months, with follow-up visits at Weeks 2, 4, 13, 26 and 39 of the OLP and every 26 weeks thereafter. Long-term Uplizna treatment provided a sustained reduction in NMOSD attack risk from baseline, regardless of when treatment was initiated: 87.7% of patients who originally received Uplizna in the RCP and 83.4% of patients who originally received placebo in the RCP remained attack-free during the OLP for at least four years. The vast majority of attacks occurred in the first year of treatment. Uplizna treatment was associated with lesion reduction shown by MRI. The mean number of active lesions was similar during the OLP to the number observed in patients who received Uplizna during the RCP. Treatment with Uplizna was generally well-tolerated for at least four years. No new safety signals were identified with prolonged Uplizna treatment and Uplizna-mediated B-cell depletion. Rates of infection or serious infection did not increase with prolonged Uplizna treatment. Levels of immunoglobins declined over time and continued to fall up to five years after the start of the OLP. No clear association between low IgG levels and severe infection can be established. Infusion-related reactions during the N-MOmentum trial were generally mild, with no unexpected safety concerns identified during continued dosing in the OLP. A separate study presented at AAN evaluated patient-reported pain scores for each of five body areas in the previous 24 hours, every four weeks during the RCP of the N-MOmentum trial, as well as during NMOSD attacks. The study used the 11-point Pain Numeric Rating Scale, or NRS-11, where 0 equals no pain and 10 equals the worst pain. Across the five body areas, patients in both groups reported episodic, rather than persistent pain during the RCP. Also in the RCP, fewer patients who received Uplizna than placebo reported a three-point worsening in NRS-11 score relative to baseline. To improve understanding of NMOSD patients' experience throughout the course of their disease, a survey was administered to 151 people living with NMOSD. The survey results demonstrate the importance of finding the right specialist who can identify appropriate screening tests that will lead to an earlier diagnosis and progression toward better patient outcomes. The average time to NMOSD diagnosis was 2.2 years, and over 10 years for some. Only 11% of survey participants were diagnosed with NMOSD when symptoms first appeared. Only 34% first shared their symptoms with an emergency room doctor and 34% first shared their symptoms with a primary care physician. Fear and frustration were the most-commonly reported emotions experienced during initial visits with a medical provider.

08:39 EDT Morgan Stanley says Q1 marked by 'numerous performance records' - Expects pre-tax margin to improve in coming years. Says adding new clients at a "record pace." Says Archegos was a "very complex event." Says Eaton Vance deal "proceeding without incident." Comments taken from Q1 earnings conference call.

08:36 EDT Inotiv to acquire Bolder BioPath for $47M - Inotiv announced that the Company has entered into an agreement and plan of merger with Bolder BioPATH, a contract pharmacology and pathology company specializing in in vivo models of rheumatoid arthritis, osteoarthritis, inflammatory bowel disease, diseases of the central nervous system and other autoimmune, inflammation, and pain models. Transaction Consideration: $47M, consisting of $18.5M in cash, a number of common shares of the Company obtained by dividing $27M, by the lessor of the weighted average closing price of Company shares as reported by NASDAQ for the twenty trading-day period ending on the third trading day prior to the closing date and the offering price per share in any stock offering by the Company prior to the closing, and a $1.5M seller's note. Bolder BioPATH Financials: 2020 revenue of $13M. Conditions: Subject to financing and customary closing conditions. Timing: Expected to close within 120 days, pending successful financing. The union of Inotiv with Bolder BioPATH, and HistoTox Labs, Inc., which business will be acquired subject to a purchase agreement announced earlier this week, will provide clients with the ability to work with one provider having expertise across a broad portfolio of services, including: Pharmacology, Toxicology, Pathology, Drug Metabolism, Pharmacokinetics, Bioanalysis, Intravascular Device and Structural Heart Models, Surgical and Medical Devices, Scientific and Regulatory Consulting. The Company expects to retain all existing Bolder BioPATH employees after transaction close.

08:30 EDT PPG says expects to complete the acquisitions of Tikkurila, Worwag during Q2 - Says day-one synergies will certainly help the company. Says Q2 tax rate is expected to be 23%-24%. Says sales volumes in the Asia-Pacific region were significantly higher on a year-over-year basis partially due to depressed sales caused by the pandemic in the prior-year period. Says expects demand recovery to continue. Says pace of recovery will vary across end-use markets and geographic regions.

08:15 EDT Horizon Therapeutics announces pooled Tepezza data published - Horizon Therapeutics announced that new pooled data from the Tepezza Phase 2 and Phase 3 clinical trials are now published in The Lancet Diabetes & Endocrinology. The data further reinforce that Tepezza improves proptosis and diplopia for TED patients in different subgroups, with most maintaining a long-term response. Tepezza, the first and only medicine approved by the FDA for TED - is a fully human monoclonal antibody, or mAb, and a targeted inhibitor of the insulin-like growth factor-1 receptor, or IGF-1R. In this report, treatment study outcomes and follow-up off-treatment data were integrated from two 24-week multicenter, double-masked, placebo-controlled clinical trials where patients were randomized to receive TEPEZZA or placebo once every three weeks for a total of eight infusions. The final treatment study visit was at Week 24, which was three weeks after the final infusion. Responses were also evaluated at seven weeks and 51 weeks after the final dose of Tepezza. Responses were analyzed for proptosis and diplopia, as well as a post-hoc analysis of a combined outcome measure: the "ophthalmic composite outcome." The composite outcome is calculated as the percentage of patients with clinical improvement in one eye in at least two of the following: proptosis, diplopia, eyelid swelling, lid aperture, globe motility and Clinical Activity Score, without deterioration of at least two of these outcomes in either eye. There was no evidence for acute disease rebound seven weeks after the last dose of Tepezza. Proptosis, diplopia and ophthalmic composite outcome responses were observed seven weeks after the last dose of Tepezza. A post-hoc analysis of the composite ophthalmic outcome indicated that 81% of Tepezza patients versus 44 of placebo patients were responders at Week 24. Proptosis, diplopia and composite outcome response were observed 51 weeks after the last dose of Tepezza for those who had long-term off-treatment data available. In a post-hoc analysis, Tepezza-treated patients with more severe disease and those with less severe disease at baseline both experienced significant improvements in proptosis and diplopia. In patients with more severe disease, those treated with Tepezza had a proptosis response of 79% compared to 17% of those who received placebo and a diplopia response of 68% compared to 31% of those who received placebo. In patients with less severe disease, those treated with Tepezza had a proptosis response of 71% compared to 9% in those who received placebo and a diplopia response of 80% compared to 30% in placebo. In post-hoc analyses, patients who received Tepezza in both the lower baseline CAS subgroup and the higher CAS subgroup demonstrated statistically significant improvements compared with placebo in proptosis and diplopia. Overall response and CAS of 0 or 1 response also improved. Post-hoc analysis from the Phase 3 study demonstrates that in patients treated with teprotumumab, those with higher or lower serum thyrotropin-binding inhibitory immunoglobulin, or TBII, baseline levels both had a proptosis response with no treatment difference between the two groups. In patients with higher baseline TBII, 71% of patients who received Tepezza experienced an improvement in diplopia compared to 23 percent (3/13) of patients who received placebo. Nearly 91% of patients in the Tepezza treatment group and the placebo treatment group completed the randomized, double-masked treatment period. There were no new safety concerns identified in the follow-up period or as part of the pooled analysis that had not been identified in the 24-week treatment period. Of those patients who experienced adverse events, most were mild to moderate in intensity during the follow-up period. There were no serious adverse events related to Tepezza treatment during the follow-up period, as assessed by trial investigators. No anti-drug antibodies were reported that impacted safety or efficacy. Of the most commonly reported adverse events with Tepezza, muscle spasm, hearing loss and hyperglycemia had the greatest risk difference from placebo. Hearing impairment events were all classified as non-serious and all patients continued in the study without event worsening or discontinuing treatment.

08:10 EDT AMC CEO pledges to not use any of 500M share issuance in 2021 - AMC Entertainment disclosed yesterday morning comments from its CEO Adam Aron during a Wednesday interview that aired on the YouTube Channel of "Trey's Trades." Aron said: "We are going to pledge right now today publicly and we will file this publicly so it will be binding on us, because you can't announce intentions and then not carry through it, we hereby pledge at AMC that if the shareholders approve this authorization for 500 million new shares to be issued we will not use one of those 500 million shares in calendar year 2021. Not one. Not one...If we need to raise some cash in the short term, remember we already have 43 million shares that are out there that were authorized in the year 2013 that we could use if we wish to raise some cash, if we decide that's a good idea. We have made no decisions yet. We are thinking about it, but we haven't made any decisions yet." Shares of AMC closed Thursday up 6% to $9.90.

08:08 EDT Zogenix announces new data from study highlighting impact of fintepla treatment - Zogenix announced new findings from an investigator-initiated study designed to assess caregivers' perspectives on the long-term seizure- and non-seizure-related benefits of fintepla on patients with Dravet syndrome and their caregivers and families. Caregivers of patients who received fintepla through either the Phase 3 clinical trial program or the U.S. early access program were recruited to participate in one-on-one semi-structured interviews. A total of 59 caregivers with a mean age of 48, 85% female, and 88% living with their partner or spouse participated in the interviews. Caregivers also provided demographic and clinical information about their child with Dravet syndrome and completed a self-report survey about their own health and quality of life. Of the participants interviewed, 34% were caregivers of adult patients with Dravet syndrome. Mean age of patients with Dravet syndrome was 15 years and they had been on the fintepla treatment regimen for an average of 21 months. The most commonly reported non-seizure-related improvements were in the areas of cognition, alertness, education, problem solving, speech, sleep quality, motor function, and mood. Caregiver parents themselves reported feeling less overwhelmed, less stress, and less anxiety and depression. More than two-thirds reported that the quality of their sleep improved and they had more time to do things they enjoy. In addition, 44% of parents reported that the relationship with their spouse or partner improved and 62% of employed parents missed less work. Reported family benefits included less family stress, improved relationship between the Dravet syndrome child and their siblings, improved behavior and/or mood of siblings, and easier time for their family to do things with others.

08:03 EDT Alaska Air expands service, presence at Santa Rosa/Sonoma County - Alaska Airlines is increasing its service and commitment to Santa Rosa/Sonoma County with more nonstop flights between Southern California and the heart of wine country. Starting June 1, the airline will offer daily nonstop service between Santa Rosa/Sonoma County and Burbank. On Sept. 8, Alaska will add additional flights to both Orange County and San Diego. With the additional flight to Hollywood Burbank Airport, the airline will have nonstop service to six destinations from Sonoma County: Burbank, Los Angeles, Portland, Orange County, San Diego and Seattle. By fall, Alaska will operate 13 peak day departures, including eight daily nonstop flights to Southern California airports.

08:02 EDT Bally's to provide plan for Richmond residents to own equity in Richmond Casino - Bally's announced that it will provide the opportunity for all Richmond residents to purchase an equity interest in, and become partial owners of, Bally's Richmond. David Walton, a Richmond-based serial entrepreneur, most known for founding the Black Pages of America, will be partnering with Bally's to roll out the program and will be providing assistance to generate awareness of this crowdfunding round.

08:02 EDT Immutep receives A$1.15M R&D tax incentive - Immutep announced that it has received a A$1,155,055 cash rebate from the Australian Federal Government's R&D tax incentive program. The cash rebate provided in respect of expenditure incurred on eligible R&D activities conducted in the 2020 fiscal year, mainly related to the Company's TACTI-mel and TACTI-002 clinical study using its lead compound eftilagimod alpha, conducted in Australia. This follows approval from AusIndustry of Immutep's application for an Advance/Overseas Finding. Due to the Advance Finding, both Immutep's Australian and overseas research and development activities related to the TACTI-002 Australian sites are eligible for the R&D Tax Incentive for a period of three years to 30 June 2021. Immutep will apply the funding towards furthering its current active clinical trial programs for its lead product, eftilagimod alpha.

07:57 EDT PNC Financial sees Q2 net interest income up 2% vs. Q1 - Sees Q2 net interest income up approximately 2% vs. Q1, with "stable" average loans. Sees Q2 fee income up approximately 3%-5% vs. Q1, and net charge-offs $150M-$200M. Noninterest expense is expected to be stable. Comments taken from Q1 earnings conference call presentation slides.

07:40 EDT Ally Financial reports Q1 return on equity 21.7%, core ROTCE 24.1%

07:36 EDT TG Therapeutics announces results from ULTIMATE I & II trials of ublituximab - TG Therapeutics announced results from two global, active-controlled, Phase 3 studies, called ULTIMATE I & II, evaluating ublituximab, the company's investigational novel, glycoengineered anti-CD20 monoclonal antibody, compared to teriflunomide, in patients with relapsing forms of multiple sclerosis. Both studies met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate over a 96-week period Key secondary MRI endpoints were also met. The ULTIMATE I & II studies investigated the safety and efficacy of a one-hour 450mg infusion of ublituximab every six months, following the Day 1 infusion. The studies were conducted under Special Protocol Assessment agreement with the U.S. Food and Drug Administration. Additionally, data from these studies are intended to support a Biologics License Application submission for ublituximab in RMS targeted in the third quarter of 2021. Data highlights from the ULTIMATE I & II Phase III studies in patients with RMS include all of the following. Primary Endpoint for both studies was based on the Annualized Relapse Rate. In ULTIMATE I, treatment with ublituximab resulted in an ARR of 0.076 compared to 0.188 for teriflunomide, representing a relative reduction of approximately 60%. In ULTIMATE II, treatment with ublituximab resulted in an ARR of 0.091 compared to 0.178 for teriflunomide, representing a relative reduction of approximately 50%. Total number of T1 Gadolinium enhancing lesions were reduced as a result of ublituximab treatment by 97% and 96% relative to treatment with teriflunomide in ULTIMATE I & II, respectively. New or enlarging T2 lesions were reduced as a result of ublituximab treatment by 92% and 90% relative to treatment with teriflunomide in ULTIMATE I & II, respectively. In ULTIMATE I, 44.6% of ublituximab treated patients achieved No Evidence of Disease Activity, or NEDA, representing a 198% improvement over teriflunomide. In ULTIMATE II, 43% of ublituximab treated patients achieved NEDA representing a 277% improvement over teriflunomide. A very low rate of disability progression was observed across all treatment groups. Only 5.2% of ublituximab treated patients showed a 12-week Confirmed Disability Progression, compared to 5.9% with teriflunomide, and only 3.3% of ublituximab treated patients showed a 24-week CDP, compared to 4.8% with teriflunomide; neither was statistically different. Ublituximab treatment increased the proportion of patients with 12-week Confirmed Disability Improvement and 24-week CDI, demonstrating a 100% improvement in 12-week CDI, and an 88% improvement in 24-week CDI compared to teriflunomide. Ublituximab was generally well tolerated with no unexpected safety signals. Overall, the proportion of patients in the ublituximab group with adverse events was similar to the teriflunomide group in a pooled analysis of both studies; the most common adverse event associated with ublituximab was infusion related reactions.

07:35 EDT Ebix subsidiary EbixCash commences IPO exercise - Ebix announced that its EbixCash Indian subsidiary has decided to commence work with immediate effect, leading to the proposed IPO of EbixCash. The Company made that decision after a meeting of all the four investment bankers with the Company a few days back. ICICI Securities, Axis Capital, SBI Capital & Edelweiss Financial Services are Lead Managers to the proposed EbixCash IPO. Accordingly, the Company has decided to engage two statutory auditors in a dual auditor role for the IPO, to commence the 3-year audit exercise leading to filing of the draft red herring prospectus, with the Securities and Exchange Board of India. DHRP is the preliminary registration document prepared by the investment bankers for the prospective IPO. The Company is targeting the filing of the DHRP by the fourth quarter of 2021 with a targeted IPO in the first quarter of 2022. EbixCash also announced earlier that it has already engaged the domestic and international legal firms for this exercise. The Company has also selected a BIG4 accounting firm for the market and product analysis sections of the DHRP. Over the next few months, the Company will be engaging a few other firms for various elements of the DHRP. A few weeks back, the Company had announced the addition of SBI Capital Markets as the fourth Lead Manager for the EbixCash IPO, besides ICICI Securities, Axis Capital & Edelweiss Financial Services who were appointed Book Running Lead Managers for the IPO earlier. ICICI Securities serves as the Left Banker for the IPO.

07:26 EDT Parsons awarded contract by city of Toronto valued at more than $10M - Parsons announced that the company was selected by the City of Toronto as the owner's engineer and technical advisor for the delivery of the F.G. Gardiner Expressway Rehabilitation project Section 2 - Dufferin Street to Strachan Avenue. The contract, valued at more than $10M, includes conceptual and preliminary design, procurement services, contract administration and inspection services for upgrading this section of the major highway connecting western Toronto to the downtown core.

07:12 EDT AstraZeneca reports U.S. clearance of proposed acquisition of Alexion - AstraZeneca's (AZN) proposed acquisition of Alexion Pharmaceuticals (ALXN) has "achieved an important step toward completion," having cleared U.S. Federal Trade Commission review following the conclusion of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, the company announced. "The announcement follows competition clearances in Canada, Brazil, Russia and other countries globally, with a full list available on astrazeneca.com. Additional global regulatory clearances are pending, including but not limited to the UK, EU and Japan," AstraZeneca said.

07:11 EDT Bitfarms starts rehabilitation of older, mid-generation mining equipment - The Company has recently started rehabilitation of older and mid-generation equipment that were previously cost-ineffective to repair. When rehabilitated, this equipment will restore approximately 80 PH/s of production to Bitfarms for a capital cost of approximately $5 per TH/s. This compares to nearly $120 per TH/s for new generation equipment on the spot market today, providing a near immediate return on investment.

07:07 EDT GX Acquisition seeks extension of deadline for Celularity deal - On April 14, GX Acquisition Corp. provided information regarding a proposal to amend GX's amended and restated certificate of incorporation to extend the date by which GX has to complete its initial business combination from May 23 to July 31. The Charter currently provides that GX has 24 months from the closing of its initial public offering (until May 23, 2021) to complete an initial business combination, which is customary for a special purpose acquisition company like GX. As previously announced, in January, GX entered into a definitive merger agreement with Celularity that would result in Celularity combining with GX and becoming a publicly listed company. Since that time, GX and Celularity have been working together to address comments from the staff of the U.S. SEC on the proxy statement/prospectus filed in connection with the transaction and to satisfy the various closing conditions contained in the merger agreement. Additionally, in recent days the SEC made a public statement regarding accounting and reporting considerations for warrants issued by special purpose acquisition companies. GX has begun a complete review of its accounting treatment of its public and private warrants, and GX's board of directors currently believes that there may not be sufficient time before May 23 to complete the review and hold a special meeting to conduct a vote for the stockholder approvals required in connection with the Celularity Business Combination and consummate the closing of the Celularity Business Combination within the legally prescribed time constraints applicable to such actions. The GX board is seeking the Extension to complete the accounting review, to allow stockholders to be able to evaluate the Celularity Business Combination and to allow additional time to consummate the Celularity Business Combination. The GX board continues to unanimously recommend that its stockholders vote "FOR" the proposal to approve and adopt the merger agreement providing for the Celularity Business Combination and each of the other proposals at the special meeting to be held in connection with the Celularity Business Combination.

07:06 EDT Largo Resources receives approval to begin trading on Nasdaq - Largo Resources receives approval from Nasdaq to list its issued and outstanding common shares on Nasdaq. Largo's common shares are expected to commence trading on the Nasdaq at the open of market trading on April 19, under the trading symbol (LGO).

07:03 EDT OTC Markets welcomes Verano Holdings to OTCQX - OTC Markets (OTCM) announced Verano Holdings (VRNOF) has qualified to trade on the OTCQX Best Market. Verano Holdings upgraded to OTCQX from the Pink market. Verano Holdings begins trading today on OTCQX under the symbol "VRNOF." "We're honored to be upgraded to OTCQX, which allows us to increase visibility and improve liquidity," said George Archos, Co-Founder and CEO of Verano. "This marks yet another step in maximizing long-term shareholder value, which we will achieve as we continue to elevate our footprint and product portfolio in key markets throughout the country."

07:02 EDT Bausch Health says VYZULTA 0.024% now approved in Brazil - Bausch Health, Bausch + Lomb, and Nicox announced that VYZULTA 0.024%, has received regulatory approval from the Brazilian Health Regulatory Agency.

06:37 EDT Eli Lilly requests FDA revoke EUA for bamlanivimab 700 mg alone - Eli Lilly (LLY) has requested the FDA revoke the Emergency Use Authorization, or EUA, for bamlanivimab 700 mg alone. Lilly made this request due to the evolving variant landscape in the U.S. and the full availability of bamlanivimab and etesevimab together. This request is not due to any new safety concern. This final step in Lilly's transition to only supply bamlanivimab and etesevimab for administration together in the U.S. for the treatment of COVID-19 - as planned with the FDA - follows the modification of contracts with the U.S. government to ensure adequate supply of etesevimab to be used together with bamlanivimab. All sites in the U.S. now have access to obtain doses of etesevimab for administration with bamlanivimab-which together neutralize more of the emerging COVID-19 variants in the U.S. than bamlanivimab alone, including the rapidly growing B.1.427/B.1.429 California strain that currently accounts for 50% of the virus in California and over 10% across a number of additional states. In the U.S., bamlanivimab alone should no longer be administered. However, sites of care should not dispose of bamlanivimab supply; instead, they should order etesevimab to pair with it. Lilly is not requesting the withdrawal of emergency authorization for bamlanivimab alone in any other jurisdiction at this time. However, its use together with etesevimab, where authorized and available, is preferred over bamlanivimab alone. Lilly, in collaboration with Amgen (AMGN), expects to manufacture sufficient supply of bamlanivimab and etesevimab together to meet global supply needs. Going forward, Lilly will submit only bamlanivimab administered with etesevimab together for authorization globally with a full transition expected by June.

06:32 EDT Sierra Metals reports Q1 production results - Results are from Sierra Metals' three underground mines in Latin America: The Yauricocha polymetallic mine in Peru, and the Bolivar copper and Cusi silver mines in Mexico. Silver production of 1M ounces; a 1% increase from Q1 2020. Copper production of 7.9M pounds; a 33% decrease from Q1 2020; mainly due to a temporary shift from copper-rich zones to lower grade polymetallic areas at Yauricocha caused by temporary operational challenges. Lead production of 9M; a 1% decrease from Q1 2020. Zinc production of 24.1M pounds; an 11% increase from Q1 2020. Gold production of 2,636 ounces; a 28% decrease from Q1 2020. Copper equivalent production of 25.5M pounds; an 18% decrease from Q1 2020. Record quarterly throughput of 3,728 tpd at the Yauricocha Mine.

06:24 EDT Citizens Financial reports Q1 net interest margin 2.76% vs. 3.10% a year ago

06:10 EDT Ideaya Biosciences announces data from ongoing darovasertib, binimetinib trial - Ideaya Biosciences (IDYA) announced clinical data from the ongoing Phase 1/2 trial evaluating darovasertib monotherapy and binimetinib combination therapy in patients with solid tumors, including Metastatic Uveal Melanoma, or MUM, and Skin Melanoma. There have been 81 darovasertib monotherapy BID MUM and seven Skin Melanoma patients enrolled across the Ideaya and Novartis (NVS) Phase 1/2 clinical trials at the time of data and analyses cutoff on April 13, with an aggregate of 88 patients evaluable for safety and 81 evaluable for efficacy based on RECIST 1.1. Reported data is preliminary and based on an unlocked database. Evaluation and follow-up of the monotherapy arm of the clinical trial continues. Overall, a 57% one-year overall survival, or OS, rate was observed in predominantly second line, third line and heavily pre-treated MUM patients with 95% CI. Historical one-year OS rate in similar MUM populations has been reported at 37%. Median OS of 13.2 months was observed in predominanantly second line, third line and heavily pre-treated MUM patients with 95% CI. Historical median OS in similar MUM populations has been reported at approximately seven months. In total, 61% of MUM patients out of 75 evaluable had tumor reduction per RECIST 1.1. evaluation, including 15 patients with greater than 30% target lesion reduction and one confirmed complete response. In the Skin Melanoma cohort, 80% of evaluable patients had tumor reduction per RECIST 1.1. evaluation, including one confirmed partial response. Overall safety profile of darovasertib monotherapy is consistent with prior reports and includes primarily common low grade but manageable GI toxicities and hypotension. The combination of darovasertib plus binimetinib is being evaluated pursuant to a clinical trial collaboration and drug supply agreement with Pfizer (PFE), which the companies have amended to support a target enrollment of approximately 40 patients in the darovasertib and binimetinib clinical combination arm in MUM. At the time of the data and analyses cutoff on April 13, twenty four MUM patients have enrolled in the darovasertib and binimetinib combination study, including eight patients dosed in the Phase 1/2 dose expansion cohort of the combination study. Reported data is preliminary and based on an unlocked database. Enrollment in the darovasertib and binimetinib combination arm of the clinical trial is ongoing. Two partial responses observed out of nine MUM patients with at least two post-baseline scans by RECIST 1.1 guidelines, including one confirmed partial response and one unconfirmed partial response awaiting a confirmatory scan 79% of evaluable MUM patients with at least one post-baseline scan show tumor reduction; follow-up for overall response is still immature. Combination doses for Phase 1/2 dose expansion have been selected based on anticipation of activity and overall tolerability in a larger treatment cohort Treatment-related adverse events observed in the darovasertib and binimetinib combination arm in MUM primarily include: nausea, vomiting, diarrhea, rash, edema, AST/ALT increase and CK increase and hypotension. Ideaya's clinical development strategy in MUM is focused on darovasertib combinations, including with binimetinib, a MEK inhibitor, and in a separate clinical study with crizotinib, a cMET inhibitor, each pursuant to the clinical trial collaboration and drug supply agreement with Pfizer.

06:04 EDT Relay Therapeutics acquires ZebiAI for $85M upfront - Relay Therapeutics announced the acquisition of ZebiAI, "a pioneer in applying massive experimental DNA encoded library data sets to power machine learning for drug discovery." Together, Relay Therapeutics and ZebiAI aspire to accelerate the application of machine learning across the Dynamo platform to potentially fast-track the finding of novel medicines against intractable targets. Under the terms of the merger agreement, Relay Therapeutics will pay $85M upfront, comprised of $20M in cash and $65M in Relay Therapeutics common stock. ZebiAI stockholders are also eligible to receive up to an additional $85M in platform and program-related milestone payments, payable in Relay Therapeutics common stock. Additionally, if Relay Therapeutics enters partnering or collaboration agreements related to ZebiAI's platform, ZebiAI stockholders are eligible to receive 10% of the payments received within the next three years, up to an aggregate cap of $100M payable in cash. The acquisition is subject to customary closing conditions. Upon closing of this acquisition, Relay Therapeutics continues to expect its current cash and cash equivalents will be sufficient to fund its current operating plan into 2024.

05:20 EDT Genentech announces new Ocrevus analyses at AAN meeting - Genentech, a member of the Roche Group, announced new Ocrevus analyses supporting its benefit on disease progression in early-stage relapsing-remitting multiple sclerosis, or RRMS, and primary progressive MS, or PPMS, as well as demonstrating persistence and adherence to twice-yearly dosing. These data are being presented virtually at the American Academy of Neurology, or AAN. Ocrevus is the number one prescribed MS medication in the U.S. for patients starting a new treatment, and more than 200,000 people have now been treated with Ocrevus globally. Ocrevus treatment provided consistent benefit over one year in patients who were recently diagnosed with RRMS and had not received prior disease modifying treatment, or DMT, in an interim analysis of open-label Phase IIIb study ENSEMBLE. After 48 weeks, 85% of Ocrevus-treated patients achieved no evidence of disease activity. The average annualized relapse rate across all patients was very low and their mean change in Expanded Disability Status Scale score, or EDSS, from baseline significantly improved from 1.71 to 1.55. Additionally, neurofilament light chain, or NfL, a marker of nerve cell damage, was reduced to nearly healthy control levels with Ocrevus treatment. The safety profile of Ocrevus in this trial was consistent with its overall favorable safety profile. Ocrevus treatment significantly slowed accumulation of atrophied T2-lesion volume, or aT2-LV, compared with placebo at 120 weeks in a post-hoc analysis of the ORATORIO study in PPMS. AT2-LV is a measure that reflects the volume of T2 lesions in brain tissue that is replaced by cerebrospinal fluid, and is believed to be a marker of disease progression in MS. People with PPMS experience three to five times higher accumulation of aT2-LV than people with relapsing MS and these data suggest that Ocrevus may favorably impact the underlying progressive biology of MS. Approximately 80% of patients adhered to twice-yearly dosing of Ocrevus after their second year of treatment compared with other DMTs, which were grouped by administration route, in a new analysis of U.S. commercial and insurance claims databases. Ocrevus also had the highest proportion of patients persist with therapy at two years. Ocrevus is approved in 95 countries across North America, South America, the Middle East, Eastern Europe, as well as in Australia, Switzerland, the United Kingdom and the EU.

05:13 EDT ING Groep COO and CTO Roel Louwhoff to leave, Ron van Kemenade to succeed as CTO - ING announced that it will separate the management board banking roles for technology and operations. Ron van Kemenade will be appointed member of the management board banking and CTO, effective May 1. After a transitional period, Roel Louwhoff, COO and CTO, will leave ING later this year to continue his career outside the company. Further announcements on his succession will be made as and when appropriate. Ron van Kemenade is currently ING's chief information officer, reporting to the COO. In his new role as CTO he will remain responsible for technology globally, including infrastructure, applications and architecture. He will also remain responsible for data management and will assume responsibility for information security. The COO will remain responsible for bankwide operations including KYC, the global transformation office and ING business shared services. Ron van Kemenade joined ING in 2003 as director Internet retail for ING Netherlands. Roel Louwhoff was appointed as ING's chief operations officer effective May 2014 and additionally as chief transformation officer in October 2016.