Replimune Group's RP1 oncolytic virus therapy faced an FDA rejection, raising concerns about the platform's viability in ...

The FDA's top regulator of cancer drugs played a key role in the rejection of a skin cancer therapy from Replimune Group, ...

Shares of Replimune (NASDAQ:REPL) plunged ~38% in the premarket on Monday after Stat News reported that the FDA’s top ...

Replimune stock falls as FDA denies skin cancer drug approval and investors sue over alleged misstatements tied to the IGNYTE ...

Replimune said the agency had issued a complete response letter regarding the company’s biologics license application for RP1, its lead candidate to treat advanced melanoma in c ...

Key Points On July 22, 2025, the U.S. Food and Drug Administration issued a Complete Response Letter for RP1, delaying potential commercialization and revenue. Research and development expenses ...

The amount of frozen funds could be as high as $200 million, or potentially more than $300 million, according to two ...

WOBURN, Mass., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today ...

The FDA's top regulator of cancer drugs interceded in a review of a Replimune skin cancer therapy, contributing to its ...

A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...

The rejection occurred amid broader turmoil at the FDA, which has been experiencing leadership changes, staff upheaval, and internal dysfunction. These organizational issues reportedly factored into ...

In a complete response letter, the FDA indicates the drug trial is not an adequate, well-controlled clinical investigation, ...