Replimune Shares Plunge Over 70% After FDA Rejects Melanoma Drug
Replimune Shares Plunge Over 70% After FDA Rejects Melanoma Drug

Replimune Shares Plunge Over 70% After FDA Rejects Melanoma Drug

News summary

Replimune Group Inc.'s shares plunged approximately 73-76% following the FDA's rejection of its melanoma treatment RP1 in combination with Bristol Myers Squibb's Opdivo. The FDA's Complete Response Letter stated that the IGNYTE trial data was not an adequate and well-controlled clinical investigation to provide substantial evidence of effectiveness, also citing concerns about the heterogeneity of the patient population and issues with the confirmatory Phase 3 study design. Despite no safety issues being raised, the FDA indicated it cannot approve the application in its current form. Replimune expressed surprise and disappointment at the decision, noting that these issues were not previously raised during mid- and late-cycle reviews, and plans to urgently work with the FDA to find a path for timely accelerated approval. Meanwhile, Wall Street analysts maintain an optimistic outlook on Replimune's future, with an average price target suggesting significant upside potential and a current consensus recommendation rating of "Outperform." The company aims to establish a major skin-cancer treatment franchise and has already built a commercial organization ahead of an expected product launch.

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