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

Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic ...

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

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

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

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, 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 ...

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

The CRL was given because the FDA did not consider the phase 1/2 IGNYTE trial to be an adequate and well-controlled clinical ...