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

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

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

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 ...

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

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

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

Replimune (REPL) stock in focus as the FDA rejects its lead drug RP1 as part of a combination regimen for melanoma, a type of ...

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

Replimune, which was seeking approval of RP1 in combination with Bristol Myers Squibb's Opdivo for the treatment of advanced melanoma, on Tuesday said the FDA issued a so-called complete response ...