Replimune Group shares are down on Thursday.

The company faces an upcoming FDA review decision on Friday, 10 April.

In October 2025, the U.S. Food and Drug Administration (FDA) accepted the resubmission of the Biologics License Application (BLA) for RP1 in combination with nivolumab for advanced melanoma patients who progress on an anti-PD-1 containing regimen.

In June 2025, the FDA issued a Complete Response Letter for the company’s RP1 (vusolimogene oderparepvec).

The FDA has indicated that the IGNYTE trial is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness.

Don’t Miss:

As per a media report in August 2025, the FDA’s top cancer…