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's RP1 treatment for advanced melanoma faces FDA rejection due to trial design issues, despite promising results ...

Replimune Group, Inc – a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies – ...

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

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

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

The FDA has issued a complete response letter to Replimune indicating it is unable to approve the biologics license ...

The FDA has rejected Replimune’s request for approval of RP1, adding the melanoma drug candidate to the list of assets to ...

The FDA’s decision to reject Replimune’s (NASDAQ:REPL) lead asset RP1 for a type of skin cancer known as melanoma appears to ...

Replimune (NASDAQ:REPL) announced on Tuesday that the U.S. Food and Drug Administration (FDA) issued a Complete Response ...

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

One-in-six patients treated with the modified virus as part of a clinical trial saw their tumors disappear completely.