Capricor Therapeutics, Inc. NASDAQ: CAPR

A securities class action has been filed on behalf of investors who purchased or otherwise acquired Capricor Therapeutics, Inc. (“Capricor” or the “Company”) (NASDAQ: CAPR) securities between December 17, 2025 and July 26, 2026, inclusive (the “Class Period”). Capricor is a biopharmaceutical company developing Deramiocel, a cell therapy for Duchenne muscular dystrophy (“DMD”).

The complaint alleges that defendants failed to disclose that: (i) Capricor had adopted changes to the pre-specified statistical analysis plan used to analyze clinical data for Deramiocel; (ii) the FDA had not agreed to those changes before Capricor resubmitted the Biologics License Application (“BLA”); (iii) as a result, there was a significant risk the FDA could conclude the clinical results did not provide substantial evidence of Deramiocel's effectiveness; and (iv) as a result, there was a substantial risk to Deramiocel's regulatory approval.

On July 27, 2026, before the market opened, the FDA published briefing documents ahead of its July 29 advisory committee meeting reviewing Deramiocel's BLA. The documents disclosed that Capricor had changed its statistical analysis plan — finalizing the revised version just one day before the clinical data was unblinded — without submitting it to the FDA for review beforehand. The FDA stated it considered analyses based on the post-study plan to be “post-hoc and exploratory,” and that the benefit-risk profile for Deramiocel appeared unfavorable given the lack of evidence supporting its effectiveness. On this news, Capricor stock fell $12.70 per share, or 64.5%, from $19.70 to close at $7.00 on July 27, 2026. On July 29, 2026, the FDA advisory committee met and voted 9-3 that available evidence did not support Deramiocel's efficacy for DMD-associated cardiomyopathy. On this news, Capricor stock fell a further $2.38 per share, or 36%, to close at $4.19 on July 30, 2026.