08:55 AM EDT, 09/02/2025 (MT Newswires) -- Replimune ( REPL ) said Tuesday it scheduled a Type A meeting with the US Food and Drug Administration to discuss a complete response letter regarding a biologics license application for RP1 in combination with nivolumab for the treatment of advanced melanoma.

The company said it has submitted a briefing book to the FDA addressing the points from the complete response letter.

Replimune ( REPL ) Chief Executive Officer Sushil Patel said that "without accelerated approval based on the current application, continuation of the RP1 program in advanced melanoma, including the phase 3 confirmatory trial, will not be viable."

Shares of the company were up 2.6% in recent premarket activity.