Key Takeaways:
Rosen Law Firm reminds Capricor Therapeutics investors of the Sept 28 lead plaintiff deadline in a securities class action.
The FDA stated in briefing documents released July 27 that Capricor's final statistical analysis plan for Deramiocel, its lead cell therapy for Duchenne muscular dystrophy, "was not submitted to FDA for review prior to BLA submission and was not discussed and consequently not agreed upon." The FDA said it considers Capricor's analyses based on post-study SAP versions to be "post-hoc and exploratory," adding that the conversion of raw change to percent change and back "adds complexity and reduces accuracy."
Capricor's stock fell $12.70, or 64%, to close at $7.00 per share on July 27 after the documents were published. The FDA's advisory committee voted 9-3 on July 29 that available evidence does not support the efficacy of Deramiocel for treating DMD-associated cardiomyopathy, and shares dropped another 36%, according to the complaint in Nkamga v. Capricor Therapeutics, Inc., No. 3:26-cv-04385 (S.D. Cal.).
The class action covers investors who purchased Capricor securities between Dec 17, 2025 and July 26, 2026. The complaint alleges Capricor and certain executives violated the Securities Exchange Act of 1934 by failing to disclose that the company adopted changes to the pre-specified SAP, that the FDA had not agreed to those changes before the BLA resubmission, and that there was a significant risk the FDA could conclude the clinical results did not provide substantial evidence of effectiveness.
Investors who purchased Capricor securities during the Class Period may move the court no later than Sept 28 to serve as lead plaintiff. The lead plaintiff is typically the movant with the greatest financial interest who is also typical and adequate of the class. An investor's ability to share in any potential recovery does not depend on serving as lead plaintiff, according to Rosen Law Firm.
Rosen Law Firm, a global investor rights firm, is among several firms — including Kaplan Fox & Kilsheimer, Kahn Swick & Foti, and Robbins Geller Rudman & Dowd — that have announced the deadline. The firms note that investors may be entitled to compensation without out-of-pocket fees through contingency fee arrangements.
The FDA's rejection of Capricor's post-study SAP analyses raises questions about the integrity of the company's clinical data submission for Deramiocel. The Sept 28 lead plaintiff deadline will determine who directs the litigation, and the outcome could carry significant financial implications for the biotech company, which had staked its regulatory path on Deramiocel approval.
This article is for informational purposes only and does not constitute investment advice.
