Replimune to resubmit twice-rejected drug for approval after FDA shakeup

Replimune announced plans to resubmit its melanoma drug for FDA approval following two previous rejections under the agency’s former leadership. The company’s decision comes shortly after the departure of FDA Commissioner Marty Makary, amid ongoing tensions between Replimune and the agency over the drug’s clinical trial design and approval process. The FDA had previously rejected the treatment, citing noncompliance with its guidance, while Replimune and some medical professionals viewed the drug as a promising new therapy for advanced melanoma. The dispute highlighted broader concerns within the pharmaceutical industry about inconsistent and shifting FDA guidance on clinical trials and drug approvals during Makary’s tenure. Several drugmakers criticized the agency for what they described as mixed messaging that complicated the development of experimental treatments. Following discussions with the FDA’s new leadership, Replimune reported alignment on a clear path forward and said it would resubmit its application imminently. The FDA has indicated it will prioritize the review and treat the resubmission as an urgent matter. Replimune emphasized the potential impact of the drug for patients with advanced melanoma who have limited treatment options after progression on prior anti-PD-1 therapies. The company’s shares surged by as much as 70% in premarket trading, reflecting investor optimism about the renewed approval prospects. With a market value of $386 million prior to the announcement, Replimune’s move underscores the significance of regulatory clarity and cooperation in advancing innovative cancer treatments.