Replimune announced its intention to resubmit its melanoma drug candidate for regulatory approval, following two prior rejections by the Food and Drug Administration. This strategic decision comes in the wake of a significant leadership transition at the FDA, including the recent departure of Commissioner Marty Makary.
Previously, Replimune had voiced criticism regarding the FDA's guidance on clinical trials and drug approvals, which the company characterized as inconsistent. The FDA, in turn, had stated that Replimune did not adhere to the agency's established protocols for conducting its clinical trials. This dispute highlighted broader concerns within the pharmaceutical industry about perceived shifts in FDA guidance for experimental drugs, potentially hindering future treatment development, according to some drugmakers.
Replimune stated that it has now achieved alignment with the FDA on the path forward for its application. The company intends to resubmit its drug application in the coming days. According to Replimune, the FDA has signaled its intention to treat this resubmission as an urgent matter and will prioritize its review process.
"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. The company's shares saw a significant surge, climbing as much as 70% in premarket trading on Friday. As of Thursday's market close, Replimune held a market valuation of $386 million.
