Replimune revives melanoma drug bid after FDA leadership shift

Following the departure of former Commissioner Marty Makary, Replimune is resubmitting its melanoma treatment for FDA approval. The company confirms it has reached a new alignment with agency regulators, aiming to break a deadlock that previously stalled the experimental therapy despite vocal support from segments of the medical community.

The previous rejections centered on a sharp dispute over clinical trial methodology. While the FDA maintained that the company failed to follow established guidance, Replimune argued the agency was unfairly blocking a vital option for patients who exhausted standard anti-PD-1 treatments. This friction became a broader symbol of industry frustration regarding inconsistent regulatory messaging during Makary’s tenure.

Under the new arrangement, the FDA has pledged to treat the upcoming resubmission as an urgent priority. Investors reacted sharply to the news, sending Replimune shares surging by as much as 70% in premarket trading on Friday. The company, which held a market valuation of $386 million at Thursday’s close, expects to deliver its formal application within the next few days.