Replimune said the agency had issued a complete response letter regarding the company’s biologics license application for RP1 ...

Replimune stock cratered Tuesday after the Food and Drug Administration unexpectedly rejected its experimental melanoma ...

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 ...

BMO Capital Markets pointed to FDA leadership, and CBER Director Vinay Prasad in particular, as potential factors in the ...

Replimune stock fell after the FDA rejected its RP1 application, citing flaws in the trial design and lack of substantial evidence for approval.