Replimune’s Shares Plunge After FDA Rejects Melanoma Drug Application
The FDA issued a Complete Response Letter (CRL), rejecting Replimune's application for accelerated approval of its experimental melanoma drug RP1 in combination with nivolumab.
Replimune shares fell approximately 76% in premarket trading following the news, dropping to below $3 per share.
The FDA cited that the IGNYTE phase 1/2 trial was not an 'adequate and well-controlled clinical investigation' and lacked 'substantial evidence of effectiveness', mainly due to heterogeneity in the patient population. No concerns were raised regarding safety.
Additional issues were identified regarding the design of Replimune's phase 3 confirmatory trial, particularly the 'contribution of components' (how each treatment component contributed to outcomes).
Replimune plans to urgently request a Type A meeting with the FDA to address these issues, but company leadership warned that without timely regulatory progress, continued development of RP1 may not be viable for advanced cancer patients with limited options.