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Replimune plans to resubmit its melanoma drug to the Food and Drug Administration for review after an exodus of leadership at the agency, the company said 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 unfairly blocking what some doctors see as a promising new way to treat skin cancer, while the FDA had said Replimune ignored the agency's guidelines in conducting its clinical trials.
The bitter fight became a flashpoint for 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 saw as rollbacks of its guidelines on clinical trials and approvals 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 that the company will resubmit its application in the coming days. Replimune said the FDA has indicated it will 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-based therapy and have limited treatment options available,” 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.
