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

Replimune faces FDA hurdles for RP1, an innovative melanoma treatment, as it seeks a path forward after receiving a complete ...

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

The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (CT03767348) trial in advanced melanoma was not ...

Replimune (REPL) announced that the U.S. Food and Drug Administration, FDA, has issued a Complete Response Letter, CRL, regarding the Biologics ...

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

Vusolimogene oderparepvec is a genetically modified herpes simplex type 1 virus designed to directly destroy tumors and generate an anti-tumor immune response.

Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. Food and Drug Administration ...

Leerink downgraded Replimune (REPL) to Market Perform from Outperform with a price target of $3, down from $21, after the FDA issued a Complete ...