Replimune plans to resubmit its melanoma drug application to the Food and Drug Administration for review in the coming days. The biotechnology company said it and the FDA are now aligned on a path forward, and that the agency has indicated it will treat the application as an urgent matter and prioritize its review.
The FDA had previously rejected the treatment twice under former Commissioner Marty Makary, who stepped down earlier this month. At the time, the FDA stated that Replimune had ignored the agency's guidance for conducting its clinical trials. Replimune had accused the FDA of wrongfully blocking what some doctors see as a promising new way to treat the skin cancer.
Replimune said the renewed submission follows what it described as constructive dialogue with the agency. "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.
Certain drugmakers had criticized the FDA under Makary’s leadership for what they saw as reversals in guidance around clinical trials and approvals for experimental drugs. Some in the drug industry perceived mixed messaging from the agency during that period.
Replimune shares spiked as much as 70% in premarket trading Friday. The company had a market value of $386 million as of Thursday’s close.
The resubmission comes after the change in FDA leadership, with Makary’s departure opening the door to renewed discussions between the agency and the company. Replimune has maintained that its clinical trial data supports the drug’s potential benefit for patients with advanced melanoma who have exhausted other treatment options.
No independent assessment was available for this report.