Here’s a concise update on Replimune Limited based on the latest available reporting.
- The U.S. FDA decision on RP1 (RP1 plus nivolumab) has dominated news cycles in 2025–2026. In July 2025 the FDA reportedly rejected the RP1 application, citing concerns about trial design and evidence, triggering a sharp stock drop and prompting discussions on next steps. This rejection followed earlier regulatory milestones, including a 2025 CRL and subsequent resubmission activity.[2][3][8]
- In early 2026, coverage highlighted an FDA action date of April 10, 2026 for a BLA resubmission, with the agency’s review discussions noting that the IGNYTE-3 data could potentially support approval, though market interpretation remained cautious given past regulatory hurdles.[1][2]
- Market and corporate updates in 2025–2026 also referenced financing and pipeline activity beyond RP1, including RP2 REVEAL for metastatic uveal melanoma and ongoing Phase 2 efforts, along with cash burn and balance sheet context as the company navigates regulatory uncertainty.[4][5][1]
If you’d like, I can pull the most current press releases or filings from Replimune’s investor relations site or the SEC to confirm the latest status and provide a brief timeline. I can also summarize the likely next steps for RP1 based on typical regulatory pathways (e.g., resubmission requirements, potential advisory committee hearings) with citations.
Sources
Replimune, which was seeking accelerated FDA approval of its lead product candidate RP1 in combination with Bristol Myers Squibb's Opdivo in adults with advanced melanoma who have previously received an anti-PD1 containing regimen, said the agency turned away the application due to concerns about the company's studies. Replimune said the FDA determined that its "Ignyte" study, on which the company's application was based, isn't an adequate and well-controlled clinical investigation that...
www.morningstar.comSep. 18, 2025 21:15
www.taiwannews.com.twFollow Replimune Group, Inc. (REPL) news, including RP1 and RP2 clinical data, FDA BLA updates, trial milestones, financial results and key oncology conference events.
www.stocktitan.netNov. 6, 2025 21:00
www.taiwannews.com.twGlobeNewswire specializes in the distribution and delivery of press releases, financial disclosures and multimedia content to the media and general public.
www.globenewswire.comTLDR FDA accepted Replimune’s resubmitted Biologics License Application for RP1 combined with Bristol Myers Squibb’s Opdivo to treat advanced melanoma The agency set April 10, 2026 as the decision deadline for the drug’s approval Replimune stock doubled on Monday, rising 100% to $9.00 per share in late-session trading The resubmission followed a complete response letter [...] The post Replimune (REPL) Stock: Biotech Shares Surge 100% on Regulatory Breakthrough appeared first on Blockonomi.
www.mexc.comReplimune stock fell after the FDA rejected its RP1 application, citing flaws in the trial design and lack of substantial evidence for approval.
www.benzinga.com