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Replimune to Resubmit Melanoma Drug Following FDA Leadership Transition

Replimune announced Friday it will resubmit its melanoma treatment for FDA approval after two previous rejections. The move follows the departure of former FDA Commissioner Marty Makary earlier this month. The company said it has now reached alignment with the agency on a regulatory path forward and plans to file the application within days. The FDA indicated it will prioritize the review as an urgent matter. Replimune previously criticized the agency for inconsistent guidance on clinical trial design and approval procedures. The pharmaceutical company joined other drugmakers in questioning what they characterized as shifting FDA messaging on experimental drug development. The company said the resubmission addresses thousands of advanced melanoma patients with limited treatment options who have not responded to existing therapies. Replimune shares jumped 70% in premarket trading Friday, with the company valued at $386 million as of Thursday's close.