Replimune Stock Falls 40% Following FDA Meeting Over Cancer Drug's Future

Replimune Group's stock plummeted by nearly 40% after a meeting with FDA officials regarding its leading drug candidate, RP1, left its future uncertain. The FDA had previously sent a complete response letter to the company, and although the meeting was described as a Type A meeting to help the drug development program proceed, Replimune's statement on next steps was neutral and didn't strike a note of confidence.

Replimune Group, Inc.'s (NASDAQ: REPL) stock experienced a significant downturn, dropping by nearly 40% during intraday trading on September 18, 2025, following a meeting with FDA officials regarding its lead drug candidate, RP1. The company announced that a Type A meeting with the FDA on September 16 to discuss its Biologics License Application (BLA) for RP1 did not yield a clear path forward under the accelerated approval pathway REPL 3-DAY DEADLINE ALERT: Replimune (REPL) Shares Tank 45% After Company Says No Pathway Identified For Lead Drug RP1, Securities Class Action Pending - Hagens Berman^[1].

This development comes on the heels of a securities class action lawsuit filed against the company, alleging that it misled investors by overstating the success of its lead cancer drug, RP1. The lawsuit alleges that the company failed to disclose fundamental flaws in the IGNYTE trial, which was the basis for the FDA's rejection of the drug's application FDA Grants Type A Meeting to Discuss RP1 Plus Nivolumab in Advanced Melanoma^[2].

The FDA's complete response letter (CRL) for RP1, issued on July 22, 2025, stated that the IGNYTE trial was not well-designed and that the FDA could not adequately interpret the results due to patient heterogeneity. The CRL also highlighted issues with the design of the planned confirmatory trial FDA Grants Type A Meeting to Discuss RP1 Plus Nivolumab in Advanced Melanoma^[2].

Replimune's statement following the Type A meeting was neutral, indicating that the company is still committed to patient access but that the continuation of the RP1 program in advanced melanoma, including the phase 3 confirmatory trial, will not be viable without accelerated approval based on the current application REPL 3-DAY DEADLINE ALERT: Replimune (REPL) Shares Tank 45% After Company Says No Pathway Identified For Lead Drug RP1, Securities Class Action Pending - Hagens Berman^[1].

Investors are urged to stay informed about the ongoing developments and potential legal actions. The lead plaintiff deadline in the securities class action lawsuit is September 22, 2025, and investors with substantial losses are encouraged to contact Hagens Berman for further information REPL 3-DAY DEADLINE ALERT: Replimune (REPL) Shares Tank 45% After Company Says No Pathway Identified For Lead Drug RP1, Securities Class Action Pending - Hagens Berman^[1].