Replimune Group Inc. | Investor Relations
The Investor Relations website contains information about Replimune Group Inc.'s business for stockholders, potential investors, and financial analysts.
ir.replimune.comReplimune’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]
What happened
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]
Recent updates
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]
Market context
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]