Replimune to resubmit melanoma drug after FDA’s Makary leaves

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

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

The bitter fight became a flashpoint for what some in the drug industry saw as mixed messaging from the FDA under Makary’s leadership. Certain drugmakers criticized the agency over what they saw as reversals of its guidance around clinical trials and approvals for experimental drugs, saying the inconsistency jeopardized future development of treatments.

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

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

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