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

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 ...

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

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

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

In a complete response letter, the FDA indicates the drug trial is not an adequate, well-controlled clinical investigation, ...

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

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

Replimune Group, Inc. (NASDAQ:REPL) saw its stock nosedive 77% on Tuesday after the company revealed it received a Complete ...

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

Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and ...

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