FDA staff say Replimune's melanoma trial fails to demonstrate efficacy

FDA staff reviewing Replimune's pivotal melanoma study concluded that the trial design did not provide sufficient evidence that the RP1 therapy works.

The assessment was issued ahead of a scheduled advisory committee meeting, raising concerns about the drug’s path to approval.

Analysts noted that the negative feedback could pressure Replimune's share price and may require additional data or a revised development plan.

The company has not yet responded publicly, and the outcome of the upcoming meeting will determine the next steps for the RP1 program.