On 29 and 30 July 2026, the same FDA advisory committee met on two different products. It voted against one and in favour of the other. On 6 August one of them was approved. The other has a decision due on 22 August.

What each panel was asked

The Cellular, Tissue, and Gene Therapies Advisory Committee met on 29 July on Capricor's deramiocel. It was asked whether the available evidence from the HOPE-3 study provides substantial evidence of effectiveness for the treatment of cardiomyopathy in Duchenne muscular dystrophy. The committee voted 9 to 3 that it does not.

The same committee met on 30 July on Replimune's vusolimogene oderparepvec with nivolumab. It was asked whether the efficacy results from the IGNYTE study are evaluable and clinically meaningful. The committee voted 10 to 3 that they are. It did not vote on whether the product should be approved.

What the briefing documents said

FDA published briefing documents before both meetings. In Capricor's case the agency said the therapy lacked efficacy. In Replimune's case FDA staff said the pivotal trial had failed to prove the product works. Both companies' share prices fell when the documents were posted. Karim Mikhail, Acting Director of the Center for Biologics Evaluation and Research, said at the start of the Capricor meeting that he stood by those documents and the agency's analysis. Earlier coverage here set out both documents in more detail.

The dispute over Capricor's analysis plan

FDA reviewers said that after the randomised, double-blind portion of HOPE-3 had completed, and during the open-label extension, changes were made to the pre-specified statistical analysis plan, generating at least two further versions. On the agency's reading the trial failed, and the efficacy claims follow from those revisions. Capricor disputes that reading. Advisers at the meeting also discussed upper limb function, a measure on which several said the case looked stronger, though still unproven.

In a statement issued after the meeting, Capricor said the committee's voting question addressed a narrower indication than the company had proposed, and did not include a vote on deramiocel's overall benefit-risk profile.

The Replimune approval

Replimune first submitted its biologics license application on 22 November 2024. The application was rejected twice, most recently in April 2026. FDA treated the resubmission as a complete class 1 response with a goal date of 2 August 2026.

On 6 August, FDA granted accelerated approval to the product, now called Tudriqev, in combination with nivolumab, for adults with unresectable advanced cutaneous melanoma who have progressed on a PD-1-blocking antibody-based regimen. The product held Breakthrough Therapy and Priority Review designations. Megha Kaushal, Acting Deputy Director of CBER's Office of Therapeutic Products, said in FDA's announcement that the approval is grounded in early evidence and backed by the accountability that accelerated approval demands.

What the approval rests on

The approval is based on IGNYTE, an open-label, multiregional, single-arm trial. It enrolled 140 patients. The efficacy-evaluable population was 91 patients, in whom the objective response rate was 24.2%, with a median duration of response of 14.1 months.

As a condition of accelerated approval, Replimune is required to run a confirmatory trial, IGNYTE-3. Continued approval depends on that trial verifying clinical benefit. Earlier coverage here set out how a confirmatory obligation attaches to the submission record, and separately how response-rate approvals have changed since Project Optimus.

Prior submission history in comparable programmes

Replimune's approval came on a third submission. Two other programmes covered here reached approval by longer routes: Outlook went four cycles, and Atara went three. Regenxbio resubmitted without running an additional study.

What is still open

Capricor's decision date is 22 August 2026. An advisory committee vote is not binding on FDA.