Capricor Therapeutics, Inc.
Case Overview
41 Days Left to Seek Lead Plaintiff
| Lead Plaintiff Deadline: | Lead Plaintiff Deadline: 09/28/2026 |
| Status: | Status: Investigating |
| Company Name: | Company Name: Capricor Therapeutics, Inc. |
| Court: | Court: Southern District of California |
| Case Number: | Case Number: 3:26cv04385 |
| Class Period: | Class Period: 12/17/2025 - 07/26/2026 |
| Ticker: | Ticker: CAPR |
| Related Attorneys: | Lead Attorneys: Thomas W. Elrod |
| Related Practices: | Related Practices: Securities |
The lawsuit alleges that Capricor made materially false and/or misleading statements and failed to disclose to investors that: (i) the Company adopted changes to the pre-specific statistical analysis plan used to analyze clinical data for its lead product candidate, Deramiocel; (ii) the FDA had not agreed to those changes before the Company resubmitted the Deramiocel Biologics License Application (“BLA”); (iii) as a result, there was a significant risk that the FDA could conclude the clinical results did not provide substantial evidence of the effectiveness of Deramiocel; and (iv) as a result, there was substantial risk to regulatory approval of Deramiocel for the treatment of Duchenne muscular dystrophy.
On July 27, 2026, the FDA released briefing documents prior to its advisory committee meeting for the Deramiocel BLA, which revealed that Capricor made changes to the pre-specified statistical analysis plan and that the final version “was not submitted to FDA for review prior to BLA submission and was not discussed and consequently not agreed upon.”. The FDA disagreed with the changes and stated, “the benefit-risk assessment for Deramiocel appears unfavorable in the absence of evidence of effectiveness.” On this news, Capricor’s stock price fell $12.70, or 64%, to close at $7.00 per share on July 27, 2026.
On July 30, 2026, Medscape reported that the FDA advisory committee, which met on July 29, 2026, voted 9-3 to conclude “that the available evidence does not support the efficacy of Deramiocel for treating DMD-associated cardiomyopathy.” On this news, Capricor’s stock price fell $2.38, or 36%, to close at $4.19 per share on July 30, 2026.
On July 27, 2026, the FDA released briefing documents prior to its advisory committee meeting for the Deramiocel BLA, which revealed that Capricor made changes to the pre-specified statistical analysis plan and that the final version “was not submitted to FDA for review prior to BLA submission and was not discussed and consequently not agreed upon.”. The FDA disagreed with the changes and stated, “the benefit-risk assessment for Deramiocel appears unfavorable in the absence of evidence of effectiveness.” On this news, Capricor’s stock price fell $12.70, or 64%, to close at $7.00 per share on July 27, 2026.
On July 30, 2026, Medscape reported that the FDA advisory committee, which met on July 29, 2026, voted 9-3 to conclude “that the available evidence does not support the efficacy of Deramiocel for treating DMD-associated cardiomyopathy.” On this news, Capricor’s stock price fell $2.38, or 36%, to close at $4.19 per share on July 30, 2026.