The law firm said it is investigating whether the biotech company and certain officers or directors engaged in securities fraud after FDA briefing documents questioned RP1 trial efficacy data.
Pomerantz LLP said it is investigating claims on behalf of investors in Replimune Group, Inc. after the company’s shares dropped sharply on July 28, 2026. The move followed briefing documents from the U.S. Food and Drug Administration (U.S. drug regulator) that raised concerns about the data package supporting accelerated approval for RP1, also known as vusolimogene oderparepvec, in combination with Bristol Myers Squibb’s PD-1 inhibitor Opdivo for adults with unresectable advanced cutaneous melanoma whose disease progressed after PD-1-blocking antibody-based therapy. The FDA said the response assessment used in the Phase 1/2 IGNYTE study "confounds interpretation of the reported efficacy results and limits FDA’s ability to verify the reported results." Replimune’s stock fell $3.28, or 38.01%, to close at $5.35 on July 28, 2026. Pomerantz said its investigation is focused on whether Replimune and certain officers or directors engaged in securities fraud or other unlawful business practices.