Nivolumab

Today, a brief rundown of news involving Regeneron Pharmaceuticals and Allogene Therapeutics, as well as updates from Bristol Myers Squibb, Biogen, and Argenxthat you may have missed.Regeneron said two more of its new drugshit regulatory setbacks because of Food and Drug Administration inspection issues at a third-party manufacturing plant. The company received a complete response letter for its bispecific cancer antibody odronextamabin lymphoma on July 30, due to issues at an Indiana factory that Novo Nordisk recently acquired from Catalent. In addition, the FDA will delay a decision on an application for high-dose Eylea processed at that plant. The odronextamab setback will require Regeneron to refile its application. The FDA previously rejected another Regeneron bispecific antibody, now approved as Lynozyfic, in multiple myeloma because of third-party manufacturing issues. Jonathan GardnerAllogene Therapeutics is stopping use of an experimental immunosuppresive antibody called ALLO-647 following the death of a study participant, the company said Friday. ALLO-647 is part of a regimen meant to prepare patients for treatment with Allogenes donor-derived cell therapy for blood cancer, cema-cel. But the antibody has been associated in rare cases with severe viral infections and, in this instance, was deemed related to an adenovirus infection that triggered liver failure in a participant in Allogenes pivotal trial. Allogene has closed the study arm with ALLO-647 and wont use it in future trials. It will move forward with a standard two-drug immunosuppressive regimen often used in cancer cell therapy. Results from the pivotal trial are still expected next year, the company said.Ben FidlerBristol Myers Squibb boosted its revenue outlook for 2025 by $700 million, driven by higher-than-expected sales of its off-patent cancer drug Revlimid. The company now expects full-year sales to be between $46.5 and $47.5 billion, although that may not flow through to the bottom line because of the $1.5 billion it has spent this year to license a BioNTech cancer drug. The unexpectedly high $838 million in Revlimid sales in the second quarter were part of a broader overperformance by the company, which beat Wall Street consensus for both its old and new drug business lines. Sales of Eliquis, Opdivo and Reblozyl were higher than expected, although cell therapy Abecma and new psoriasis drug Sotyktu were below, according to Leerink Partners analyst David Risinger. Jonathan GardnerBiogen shares rose as much as 7% Thursday after the biotechnology companys latest earnings report surpassed Wall Street expectations. The company recorded $2.6 billion in revenue from April through the end of June, with $160 million coming from Leqembi, its closely watched drug for Alzheimers disease. Biogen also raised its forecasts for 2025 revenue and earnings per share. To Brian Abrahams, an analyst at the investment bank RBC Capital Markets, the results were indicative that Biogens efforts to turn around the business are starting to show. We see considerable room for upside, he wrote in a note to clients. Jacob BellShares of Argenx climbed by double digits following quarterly sales numbers for its autoimmune drug Vyvgart that handily topped investor expectations. According to Argenx, the companys multiple Vyvgart formulations combined to generate nearly $949 million in revenue between April and June, beating consensus estimates by more than $80 million. The blowout performance included impressive numbers across Vyvgarts approved indications and different versions, wrote William Blair analyst Myles Minter on Thursday. Leerink Partners Thomas Smith now projects more than $9 billion in combined peak yearly sales. Argenxs market value rose past $40 billion on the news. Ben Fidler '

REPL Investors with Losses Encouraged to Contact Hagens Berman SAN FRANCISCO, July 31, 2025 /PRNewswire/ -- A securities class action lawsuit, styled Jboor v. Replimune Group, Inc., et al., No. 1:25-cv-12085 (D. Mass.), has been filed and seeks to represent investors who purchased or otherwise acquired Replimune ( NADAQ: REPL) securities between November 22, 2024 and July 21, 2025. The lawsuit comes after Replimune investors witnessed a 77% collapse in the price of their shares on July 22 when the company announced that the Food and Drug Administration (FDA) had rejected its application for RP1, a new drug intended to treat advanced melanoma when used with nivolumab. The news, which arrived via a "complete response letter" — the FDA's formal way of saying "no" for now — triggered unusually high trading volume as investors rushed to sell. National shareholders rights firm Hagens Berman is continuing its investigation into whether Replimune may have misled investors about the IGNYTE study- the main study supporting Replimune's application. The firm urges Replimune investors who suffered substantial losses to submit your losses now. The firm also encourages persons with knowledge who may be able to assist in the investigation to contact its attorneys. Class Period: Nov. 22, 2024 – July 21, 2025 Lead Plaintiff Deadline: Sept. 22, 2025 Visit: Contact the Firm Now: [email protected] 844-916-0895 Replimune Group, Inc. (REPL) Securities Class Action: The lawsuit is focused on the propriety of Replimune's statements concerning data submitted to the FDA in support of its Biologics License Application (BLA). Throughout the Class Period, Replimune had painted an optimistic picture for RP1, citing its Breakthrough Therapy designation by the FDA, its Accelerated Approval pathway, and assurances that "data from the IGNYTE study shows that roughly one-third of patients are able to achieve durable response in a high unmet need setting with few options." These in turn fueled hopes that RP1 could offer a crucial new treatment for a particularly aggressive form of skin cancer. The complaint alleges that Replimune made false and misleading statements while failing to disclose that (1) the company recklessly overstated the IGNYTE trial's prospects, and (2) the FDA was likely to deem the IGNYTE trial inadequate and not well-controlled. Investors' hopes for RP1 were severely dashed by its July 22nd announcement. Replimune revealed that the FDA's letter made it clear that the agency was "unable to approve the application in its present form." More critically, the FDA stated that the IGNYTE trial was not considered a sufficiently well-designed or controlled investigation to provide solid proof of the drug's effectiveness. This suggests fundamental issues with how the trial was conducted. Furthermore, the FDA found that the trial's results could not be properly understood because of the wide variation in the patient population included in the study. Essentially, the patients in the trial were too different from each other, making it difficult to draw reliable conclusions about the drug's impact. The agency also pointed out problems with the design of the necessary confirmatory trial, including questions about how each component of the treatment contributed to the overall effect. The market reacted swiftly, sending the price of Replimune shares crashing 77% lower on unusually high volume on July 22, 2025. "We're investigating whether Replimune may have misled investors about its IGNYTE trial design and data," said Reed Kathrein, the Hagens Berman partner leading the investigation. If you invested in Replimune and have substantial losses, or have knowledge that may assist the firm's investigation, submit your losses now » If you'd like more information and answers to frequently asked questions about the Replimune case and our investigation, read more » Whistleblowers: Persons with non-public information regarding Replimune should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email [email protected]. About Hagens Berman Hagens Berman is a global plaintiffs' rights complex litigation firm focusing on corporate accountability. The firm is home to a robust practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and other wrongdoings. Hagens Berman's team has secured more than $2.9 billion in this area of law. More about the firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw. Contact: Reed Kathrein, 844-916-0895 SOURCE Hagens Berman Sobol Shapiro LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED