Replimune receives second FDA rejection for lead melanoma drug RP1

Filed April 13, 2026 · Period ending April 10, 2026 · ~1 min read

Key Changes

• high

  FDA issued second Complete Response Letter for RP1 combined with nivolumab in advanced melanoma, meaning the application cannot be approved in its current form and requires the company to address deficiencies before resubmission.

  Item 8.01 verify on EDGAR →
• high

  This is the second rejection for the same application, indicating persistent regulatory hurdles for the company's lead drug candidate and potentially delaying commercialization timeline.

  Item 8.01 verify on EDGAR →