By Mackenzie Tatananni
Shares of Replimune Group sank on Friday after an application for an experimental skin cancer drug was rejected by the Food and Drug Administration for the second time.
The agency declined to approve Replimune's lead investigational immunotherapy, RP1, in combination with Bristol Myers Squibb's Opdivo for the treatment of advanced melanoma.
At last check, Replimune shares were down 19% at $4.76, putting the stock on pace for its lowest close since October, according to Dow Jones Market Data. Trading paused twice due to volatility.
The FDA rejected an application for the drug in July, two months after Vinay Prasad was appointed to lead the agency's Center for Biologics Evaluation and Research.
Regulators said at the time that a clinical trial evaluating the efficacy of RP1 wasn't adequately controlled and failed to provide "substantial evidence of effectiveness," though the FDA raised no safety concerns.
Following that setback, Replimune resubmitted its Biologics License Application, which was accepted for consideration in October 2025.
Write to Mackenzie Tatananni at mackenzie.tatananni@barrons.com
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April 10, 2026 12:17 ET (16:17 GMT)
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