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

A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...

The lawsuit comes after Replimune investors witnessed a 77% collapse in the price of their shares on July 22 when the company announced that the Food and Drug Administration (FDA) had rejected its ...

The FDA has issued a CRL to Replimmune regarding the BLA for vusolimogene oderparepvec (RP1) in combination with nivolumab for advanced melanoma.

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

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

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

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.