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 ...

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 has rejected Replimune’s request for approval of RP1, adding the melanoma drug candidate to the list of assets to receive complete response letters from the new-look agency. Investors sent the ...

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 ...

One of the most notable accomplishments of the first Trump Administration was its willingness to take on the status quo of ...

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

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 ...

Replimune, which was seeking approval of RP1 in combination with Bristol Myers Squibb's Opdivo for the treatment of advanced melanoma, on Tuesday said the FDA issued a so-called complete response ...