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

Replimune (REPL) stock plummeted on Tuesday after the biotechnology company received a Complete Response Letter (CRL) from ...

Replimune Group, Inc. faces FDA setbacks with RP1, raising financial risks and dilution concerns. Click here to find out why ...

Replimune (REPL) stock rebounds even as FDA rejection of its RP1 skin cancer drug lead to multiple analyst downgrades on Wall Street. Read more here.

Analysts questioned whether the complete response letter Replimune received was evidence of changing approval standards at the FDA.

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

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