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

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 ...

Replimune (REPL) stock plummets as report suggests FDA’s top regulator of cancer drugs intervened in rejecting its lead asset ...

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 played a key role in the rejection of a skin cancer therapy from Replimune Group, ...

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

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 ...

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

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

Following a complete response letter rejecting accelerated approval for RP1 in advanced melanoma, IGNYTE trial investigators are urging the FDA to reevaluate the therapy’s robust survival data, just ...

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 ...