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

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

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

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 ...

Replimune (NASDAQ:REPL) stock surges as Cantor Fitzgerald upgrades, citing improved odds for approval of its lead drug after an FDA leadership change. Read more here.

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 ...

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

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

A securities class action lawsuit, styled Jboor v. Replimune Group, Inc., et al., No. 1:25-cv-12085 (D. Mass.), has been filed and seeks ...

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

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