Replimune Group IncFDA briefing documents raised concerns about RP1 data, causing stock to drop 38%

Pomerantz LLP is investigating claims on behalf of investors of Replimune Group, Inc. concerning whether the company and certain officers or directors engaged in securities fraud or other unlawful business practices. The investigation follows the U.S. Food and Drug Administration's publication of briefing documents on July 28, 2026, which raised concerns about the data package supporting accelerated approval for Replimune's drug RP1 in combination with Bristol Myers Squibb's Opdivo for advanced melanoma. The FDA stated that the response assessment in the Phase 1/2 IGNYTE study confounds interpretation of efficacy results and limits the agency's ability to verify reported results. On that news, Replimune's stock price fell $3.28 per share, or 38.01%, to close at $5.35 per share. Investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, extension 7980.
Replimune Group IncFDA briefing documents raised concerns about RP1 data, causing stock to drop 38%
Bristol-Myers Squibb Company