What are the next steps for RP1's BLA following the September 16, 2025, FDA Type A meeting?

Replimune Group, Inc. (US:REPL) has made significant progress on the regulatory pathway for its RP1 Biologics License Application (BLA) following the Type A meeting with the FDA on September 16, 2025.

Here's a breakdown of the key developments:

• Complete Response Letter (CRL): On July 22, 2025, Replimune received a CRL from the FDA for the RP1 BLA in combination with nivolumab for advanced melanoma. The FDA cited concerns regarding the IGNYTE trial's design, specifically the heterogeneity of the patient population, and issues with the confirmatory trial design, stating it was not considered an adequate and well-controlled clinical investigation. Importantly, no safety concerns were raised.1
• Type A Meeting: Replimune announced on September 2, 2025, that a Type A meeting with the FDA was scheduled for September 16, 2025, to discuss the CRL. The company submitted a briefing book to address the FDA's points.2 Following the meeting, on September 18, 2025, Replimune stated that it was evaluating the feedback to determine next steps, and a path forward under the accelerated approval pathway had not yet been determined.3
• BLA Resubmission and New PDUFA Date: Most recently, on October 20, 2025, Replimune announced that the FDA accepted the resubmission of the BLA for RP1. A new Prescription Drug User Fee Act (PDUFA) target action date has been set for April 10, 2026, based on a Class II resubmission timeline.4

Therefore, the immediate next steps following the Type A meeting involved Replimune resubmitting the BLA with additional information, data, and analyses to address the FDA's feedback. The focus now shifts to the FDA's review of this resubmission leading up to the new PDUFA date.