09:57 AM EDT, 09/18/2025 (MT Newswires) -- Replimune ( REPL ) said Thursday that a path forward for its biologics license application for RP1 plus nivolumab to treat advanced melanoma has not been determined.

The company said it recently completed a type A meeting with the US Food and Drug Administration to discuss the regulator's complete response letter for the RP1 combination therapy.

Replimune ( REPL ) said it is assessing the FDA's feedback during the meeting to decide on next steps, adding that it was committed to working with the FDA in finding a path forward for RP1.

The company's shares fell 38% in recent trading Thursday.

Price: 3.54, Change: -2.17, Percent Change: -38.00