Replimune will resubmit melanoma drug after Makary leaves FDA

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Replenishment plans to resubmit its melanoma drug to the Food and Drug Administration for review after a leadership change at the agency, the company said Friday.

The FDA rejected Replimune’s melanoma treatment twice under previous FDA leadership, including former Commissioner Marty Makary, who resigned earlier this month. Replimune had accused the FDA of unfairly blocking what some doctors see as a promising new way to treat skin cancer, while the FDA said Replimune had ignored the agency’s guidelines for conducting its clinical trials.

The bitter fight became the focus of what some in the pharmaceutical industry saw as mixed messages from the FDA under Makary’s leadership. Certain drugmakers criticized the agency for what they said was a reversal of its guidance on clinical trials and approvals for experimental drugs, saying the inconsistency jeopardized future development of treatments.

Replimune said it and the FDA are now on a common path and the company will resubmit its application in the coming days. Replimune said the FDA indicated it would treat the application as an urgent matter and prioritize its review.

“This constructive dialogue represents an important step forward for the thousands of patients with advanced melanoma who have progressed on prior anti-PD-1-based therapy and have limited treatment options,” Replimune said in a statement.

Replimune shares rose as much as 70% in premarket trading on Friday. Replimune had a market value of $386 million as of Thursday’s close.

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