Capricor disputes FDA post-hoc analyses of deramiocel data ahead of July 29 advisory panel

Reuters2026/07/27 15:01

By:Reuters

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Capricor issued a rebuttal to FDA briefing materials ahead of a July 29 advisory committee on its deramiocel BLA in Duchenne muscular dystrophy.
Management said it responded to all FDA requests and that results are governed by SAP version 3.0, finalized before unblinding.
It challenged FDA post-hoc analyses as based on SAP version 1.1, described as an unsigned, incomplete internal draft later made obsolete.
Capricor said Phase 3 HOPE-3 met its primary endpoint, PUL 2.0, with supportive cardiac function benefits.
Slides were posted on its website to frame the discussion for stakeholders ahead of the meeting.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Capricor Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202607271100PRIMZONEFULLFEED9798564) on July 27, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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Capricor disputes FDA post-hoc analyses of deramiocel data ahead of July 29 advisory panel

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