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

Shares of Replimune Group Inc. (NASDAQ:REPL) plunged 36% in premarket trading after a report revealed new details about the ...

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

The FDA has rejected Replimune’s request for approval of RP1, adding the melanoma drug candidate to the list of assets to ...

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

San Diego’s once-sizzling biotech scene is now in a cold snap. It’s left some workers desperate after months of fruitless job ...

Replimune's RP1 treatment for advanced melanoma faces FDA rejection due to trial design issues, despite promising results ...

The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (NCT03767348) trial in advanced melanoma was not ...

CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Replimune Group, Inc. investors who were adversely affected by alleged securities fraud between November 22, 2024 and July 21, 2025.

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 Group, Inc – a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies – ...

Replimune (REPL) stock in focus as the FDA rejects its lead drug RP1 as part of a combination regimen for melanoma, a type of skin cancer. Read more here.