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

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

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

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

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 ...

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

The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (CT03767348) trial in advanced melanoma was not an adequate, well-controlled study and that its heterogeneous patient ...

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

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.

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

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 ...