Capricor’s Chief Executive Officer and Chief Financial Officer are named as individual defendants in a securities class action alleging they controlled and certified public statements about the HOPE-3 trial that allegedly omitted unagreed changes to the study’s pre-specified statistical analysis plan.
NEW YORK, Aug. 10, 2026 (GLOBE NEWSWIRE) — Levi & Korsinsky, LLP alerts investors in Capricor Therapeutics, Inc. (NASDAQ: CAPR) of a pending securities class action brought on behalf of shareholders who purchased securities between December 17, 2025 and July 26, 2026. Find out if you may qualify to recover losses. You may also contact Joseph E. Levi, Esq. at [email protected] or (212) 363-7500.
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. To be considered for lead plaintiff, investors must file by September 28, 2026.
The Named Individual Defendants
The pleading asserts claims against Linda Marbán, Chief Executive Officer at all relevant times, and Anthony J. Bergmann, Chief Financial Officer at all relevant times, in addition to the Company. Both are alleged to have held positions giving them authority over the content of Capricor’s SEC reports, press releases, and presentations to analysts and institutional investors.
Alleged Control Person Liability
- The complaint charges that the Individual Defendants possessed the power to control the contents of Company reports, press releases, and investor presentations describing the Phase 3 HOPE-3 program.
- Each is alleged to have received copies of the challenged statements before or shortly after issuance, with the ability to prevent or correct them.
- As averred, neither disclosed that changes had been adopted to the pre-specified statistical analysis plan used to analyze deramiocel clinical data.
- The action claims the FDA had not agreed to those changes before the Biologics License Application was resubmitted.
- Certifications furnished under Sarbanes-Oxley Sections 302 and 906 accompanied the Company’s annual report on Form 10-K filed March 17, 2026, which described alignment with the agency on a regulatory path forward.
- Section 20(a) of the Securities Exchange Act of 1934 permits recovery from individuals alleged to have controlled a primary violator, meaning officers may be held personally answerable alongside the issuer.
Sarbanes-Oxley Certification Obligations
The complaint charges that because of their positions and access to material non-public information, the Individual Defendants knew that adverse facts described in the action had not been disclosed to the public. FDA briefing documents released July 27, 2026 stated that the final statistical analysis plan, version 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,” and that the agency considered the resulting analyses “post-hoc and exploratory.”
“Corporate officers have a duty to ensure their companies’ public statements are accurate and complete. Here the complaint alleges that senior management represented HOPE-3 results as statistically significant without disclosing that the governing analysis plan had been revised without FDA agreement.” — Joseph E. Levi, Esq.
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Frequently Asked Questions About the CAPR Lawsuit
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 specific misstatements does the CAPR lawsuit allege? A: The complaint alleges Capricor Therapeutics made materially false or misleading statements regarding the HOPE-3 statistical analysis plan and the likelihood of regulatory approval for deramiocel during the Class Period. When FDA briefing documents described the Company’s analyses as post-hoc and exploratory, the stock price declined sharply.
Q: How much did CAPR stock drop? A: Shares fell approximately 78.7%, a decline of an aggregate $15.08 per share across two corrective disclosures, after FDA briefing documents disclosed unagreed changes to the pre-specified statistical analysis plan and an advisory committee voted 9-3 against supporting efficacy. Investors who purchased shares during the Class Period at artificially inflated prices and suffered losses may be eligible to seek compensation.
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: What is a lead plaintiff and why does it matter? A: A lead plaintiff is the investor appointed by the court to represent the entire class. Lead plaintiffs are typically investors with the largest documented losses. Being appointed does not increase individual recovery but gives direct oversight of how the case is run.
Q: What do CAPR investors need to do right now? A: Gather brokerage records including purchase dates, share quantities, and prices paid. Contact Levi & Korsinsky for a free, no-obligation evaluation at [email protected] or (212) 363-7500. No immediate action is required to remain eligible as an absent class member.
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: Do I need to go to court or give testimony? A: No. The overwhelming majority of class members never appear in court or give depositions. If there is a settlement or recovery, eligible class members generally submit a claim form to seek their portion.
CONTACT:
Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
Ed Korsinsky, Esq.
33 Whitehall Street, 27th Floor
New York, NY 10004
Tel: (212) 363-7500
Fax: (212) 363-7171
Attorney Advertising. Prior results do not guarantee similar outcomes.
