Replimune’s most recent major news is that the FDA issued a Complete Response Letter on April 10, 2026 for RP1 plus nivolumab in advanced melanoma, meaning the agency did not approve the application at that time. Replimune also said it disagreed with the FDA’s assessment and pointed to IGNYTE trial data showing a 34% response rate and a median duration of response of 24.8 months.[1]
The company’s press release says the CRL relates to its BLA for RP1 in combination with nivolumab for advanced melanoma. Reuters reported the same decision as another FDA rejection for the experimental skin-cancer treatment. StatNews also described the decision as a setback for Replimune’s melanoma program.[4][8][1]
Replimune’s investor relations page shows the April 10, 2026 CRL as the latest press release, followed by a March 2, 2026 investor-conference announcement and a February 3, 2026 quarterly financial update. A later news roundup also notes that Replimune is scheduled to present at the 2026 ASCO Annual Meeting in late May and early June.[2][3]
The CRL appears to be the main driver of recent coverage around Replimune, with reporting focused on regulatory uncertainty for RP1 and the company’s response. If you want, I can also give you a concise timeline of Replimune’s 2025–2026 news flow.[8][2]
WOBURN, Mass., April 10, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the company received a complete response letter (CRL) from the U.S.
ir.replimune.comThe Investor Relations website contains information about Replimune Group Inc.'s business for stockholders, potential investors, and financial analysts.
ir.replimune.comFollow 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.netA cancer drug candidate that, rightly or wrongly, became a flashpoint at FDA, fails on a second try at approval.
www.statnews.comThe Investor Relations website contains information about Replimune Group Inc.'s business for stockholders, potential investors, and financial analysts.
ir.replimune.com