The Miami Entrepreneur

: Replimune shares plunge as skin cancer therapy fails to meet primary clinical-trial goals

Replimune Group Inc. shares REPL dropped more than 40% premarket on Tuesday after the biotech company said an investigational cancer therapy had failed to meet its primary goals in a clinical trial in skin cancer. The therapy, RP1, was studied in combination with cemiplimab, a Regeneron Pharmaceuticals Inc. REGN monoclonal antibody branded as Libtayo. The combination therapy showed a clinically meaningful improvement in response rate and duration in patients with cutaneous squamous cell carcinoma, compared with Libtayo alone, but the complete response rate fell short of the study’s statistical significance threshold, Replimune said in a release. The trial will continue as planned to assess overall survival and other factors, the company said. Replimune also said it would halt development of its investigational RP2 and RP3 therapies in squamous cell carcinoma of the head and neck and colorectal cancer. As of Sept. 30, the company said it had cash and investments totaling $496.8 million, and the reshuffling of portfolio priorities is expected to extend its cash runway to early 2026. Replimune shares have dropped 55% in the year to date, while the S&P 500 SPX has gained 19%.

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