Replimune Says Path Forward Not Determined for RP1 in Advanced Melanoma

MT Newswires Live

Sep 18

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 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

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