Shares of Replimune Group, Inc. (NASDAQ:REPL) are rising Monday after the clinical stage biotechnology company shared an important regulatory update. What To Know: Replimune said the U.S. Food and ...

On July 22, 2025, Replimune publicly announced that the U.S. Food and Drug Administration (FDA) had issued a "Complete Response Letter" (CRL) for its Biologics License Application (BLA) for RP1. This ...

Replimune received a complete response letter from the FDA, denying accelerated approval for RP1 plus Opdivo in advanced melanoma for now. The FDA cited issues with the IGNYTE trial design and patient ...

The fate of a once-promising cancer treatment now looks uncertain at best. The meeting was conducted with U.S. Food and Drug Administration (FDA) officials, and it took place on Tuesday. The subject ...

Replimune (NASDAQ:REPL) shares fell sharply after the company said it has yet to determine the accelerated approval pathway for its lead drug RP1, following a recent meeting with the U.S. FDA.

NEW YORK--(BUSINESS WIRE)--Leading securities law firm Bleichmar Fonti & Auld LLP announces an investigation into Replimune Group, Inc. (NASDAQ: REPL) for potential violations of the federal ...

Multiple analysts have issued price targets for $REPL recently. We have seen 4 analysts offer price targets for $REPL in the last 6 months, with a median target of ...

Replimune Group, Inc. (NASDAQ:REPL) stock plunged on Tuesday after a U.S. Food and Drug Administration (FDA) update. The clinical stage biotechnology company received an FDA Complete Response Letter ...