A securities class action alleges Capricor Therapeutics told investors its Deramiocel application was progressing toward an August 22, 2026 PDUFA date while allegedly omitting that the final statistical analysis plan governing HOPE-3 was never submitted to or agreed upon by the FDA before the BLA resubmission
NEW YORK, Aug. 11, 2026 (GLOBE NEWSWIRE) — SueWallSt notifies investors in Capricor Therapeutics, Inc. (NASDAQ: CAPR) that a securities class action has been filed on behalf of shareholders who purchased securities between December 17, 2025 and July 26, 2026. Submit your information now. You may also contact Joseph E. Levi, Esq. at [email protected] or (888) SueWallSt.
CAPR fell from $19.70 on July 24, 2026, to $4.19, a decline of approximately 78.7%, with an aggregate corrective-disclosure loss of $15.08 per share. The stock dropped $12.70 (64%) to $7.00 on July 27, 2026, then $2.38 (36%) on July 30, 2026. The lead plaintiff deadline is September 28, 2026.
What the Company Told Regulators and Investors
After receiving a July 2025 Complete Response Letter stating the application “does not meet the statutory requirement for substantial evidence of effectiveness,” Capricor announced in March 2026 that the FDA had lifted the CRL, classified the filing as a Class 2 resubmission, and set a PDUFA target action date of August 22, 2026. SEC filings and press releases described HOPE-3 as having met its primary endpoint (p=0.03) and key secondary cardiac endpoint (p=0.04), with the Company adding that the FDA “has not identified any potential review issues.”
Disclosure Gaps Alleged in the Regulatory Narrative
- The complaint challenges the omission that changes were made to the pre-specified statistical analysis plan, generating at least two additional versions after the double-blind portion concluded.
- FDA briefing documents stated the final SAP (v. 3.0), dated November 24, 2025, “was not submitted to FDA for review prior to BLA submission and was not discussed and consequently not agreed upon.”
- The final SAP was allegedly created one day before the data was unblinded.
- Briefing documents indicated the process for SAP changes in the study’s pre-specified blinding plan was not followed, and that Protocol 9.0 deviated from SAP v. 3.0.
- The FDA stated it “does not consider the conversion of raw change to percent change and then back to raw change to have been scientifically justified.”
- Hypersensitivity reactions in 42% of treated patients versus 15% of placebo patients allegedly raised the possibility of functional unblinding.
The FDA characterized the resulting analyses as “post-hoc and exploratory” and wrote that “the benefit-risk assessment for deramiocel appears unfavorable in the absence of evidence of effectiveness.” On July 29, 2026, an advisory committee voted 9-3 that available evidence does not support efficacy for DMD-associated cardiomyopathy.
“Generic risk factor language cannot substitute for disclosing specific, known problems already affecting a company’s regulatory position. The complaint alleges investors were not told that the analytical plan underlying the reported HOPE-3 results had not been agreed upon with the FDA.” — Joseph E. Levi, Esq.
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Frequently Asked Questions About the CAPR Lawsuit
Q: What specific misstatements does the CAPR lawsuit allege? A: The complaint alleges Capricor Therapeutics made materially false or misleading statements regarding the pre-specified statistical analysis plan for HOPE-3, FDA agreement with changes to that plan, and the resulting risk to regulatory approval of Deramiocel. When the FDA briefing documents and advisory committee outcome were disclosed, the stock price declined sharply.
Q: What court was the CAPR class action filed in? A: The case was filed in the United States District Court for the Southern District of California, governed by the Private Securities Litigation Reform Act of 1995.
Q: Who are the defendants named in the CAPR lawsuit? A: The complaint names Capricor Therapeutics, Inc. and individual defendants including senior executives who signed SEC filings, made public statements, or certified financial disclosures under Sarbanes-Oxley.
Q: What do CAPR investors need to do right now? A: Gather brokerage records including purchase dates, share quantities, and prices paid. Contact SueWallSt, a brand of Levi & Korsinsky LLP, for a no-cost, no-obligation evaluation at [email protected] or (212) 363-7500. No immediate action is required to remain eligible to participate in the investigation.
Q: What happens after I contact Levi & Korsinsky? A: An attorney will review your trading history at no cost and provide an initial assessment of your potential eligibility.
Q: What if I already sold my CAPR shares — can I still recover losses? A: Yes. Eligibility is based on when you purchased, not whether you still hold the shares. Investors who bought during the Class Period and sold at a loss may still be eligible to participate.
Q: What does it cost me to participate? A: There is no upfront cost to contact the firm. Securities class actions are generally handled on a pure contingency basis. No upfront fees, no retainer, and no out-of-pocket costs. Any attorneys’ fees and expenses awarded to class counsel are subject to court approval.
Q: What if I live outside the United States? A: U.S. securities class actions generally cover purchases on U.S. exchanges regardless of the investor’s country of residence.
CONTACT:
Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
33 Whitehall Street, 27th Floor
New York, NY 10004
Tel: (888) SueWallSt
Fax: (212) 363-7171
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