11:12 AM EDT, 07/22/2025 (MT Newswires) -- Replimune Group ( REPL ) could need a "significant restructuring" in the near term to accommodate changes to the study of RP1 in combination with nivolumab in advanced melanoma, Wedbush Securities said in a Tuesday note.

The US Food and Drug Administration did not approve the company's biologics license application for the experimental drug, saying it does not consider the application's supporting trial to be an "adequate and well-controlled" study to provide evidence of efficacy.

According to Wedbush, the FDA's complete response letter also indicated that the trial design has issues that need to be addressed including "contribution of components." In response to the CRL, Replimune ( REPL ) said it plans to request a type A meeting with the FDA and work with the agency on a path forward.

"We conservatively assume the IGNYTE Ph 3 study will have to be restarted with a new design, pushing our approval timelines back to late 2030," said Wedbush.

Wedbush downgraded Replimune ( REPL ) to neutral from outperform, with a lower price target of $4 from $19.

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