Replimune reaches agreement with US FDA to resubmit melanoma drug application

Replimune said on Friday it it has reached an agreement with the U.S. Food and Drug Administration to resubmit the marketing application for its experimental skin cancer drug after the regulator twice declined to approve the therapy.

The company said it will resubmit the application for vusolimogene oderparepvec in the coming days.

Shares of the company jumped nearly 74% in premarket trading.

Replimune said the FDA has indicated it will treat the resubmission as an urgent matter upon receipt and will prioritize its review.

(Reporting by Mariam Sunny in Bengaluru; Editing by Shinjini Ganguli)

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This story was originally published May 29, 2026 at 5:12 AM.