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Replimune plans to resubmit its melanoma drug to the Food and Drug Administration for review after an exodus of the agency’s leadership, the company announced Friday.
The FDA twice rejected Replimune’s melanoma treatment under previous FDA leadership, including former Commissioner Marty Makary, who resigned earlier this month. Replimune had accused the FDA of wrongly blocking what some doctors say was a promising new way to treat skin cancer, while the FDA had said Replimune ignored the agency’s guidelines in conducting its clinical trials.
That tug of war became a flashpoint for what some in the pharmaceutical industry saw as mixed messages from the FDA under Makary’s leadership. Some drugmakers criticized the agency for what they saw as a reversal of its guidelines for clinical trials and approval of experimental drugs, saying the inconsistency jeopardized future development of treatments.
Replimune said it and the FDA are now aligned on the path forward and the company will resubmit its application in the coming days. Replimune said the FDA indicated it would treat the request as an urgent matter and 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 therapy and who have limited treatment options,” Replimune said in a statement.
Shares of Replimune soared as much as 70% in premarket trading Friday. Replimune had a market value of $386 million as of Thursday’s close.
