CAPR Shareholder Alert: September 28, 2026 Lead Plaintiff Deadline in Capricor Therapeutics, Inc. Securities Class Action - Contact SueWallSt

A securities class action alleges Capricor Therapeutics downplayed the risk that its Phase 3 HOPE-3 trial may have been functionally unblinded by a distinctive hypersensitivity reaction profile, an issue FDA reviewers later flagged before CAPR shares fell roughly 78.7%

NEW YORK, Aug. 18, 2026 (GLOBE NEWSWIRE) -- SueWallSt alerts investors in Capricor Therapeutics, Inc. (NASDAQ: CAPR) of a pending securities class action on behalf of shareholders who purchased securities between December 17, 2025 and July 26, 2026. Check if you might be eligible to recover your investment losses. You may also contact Joseph E. Levi, Esq. at jlevi@SueWallSt.com or (888) SueWallSt.

CAPR shares declined approximately 78.7% across two trading sessions after FDA advisory committee materials became public, a cumulative drop of about $15.08 per share. The Court has set September 28, 2026 as the deadline to apply for lead plaintiff appointment.

"Investors deserve transparency about material risks that could affect their investments. The complaint alleges that shareholders were not told of the risk that treatment assignment in HOPE-3 could be inferred despite formal blinding conditions." -- Joseph E. Levi, Esq.

The Alleged Blinding Integrity Concentration in HOPE-3

FDA briefing documents released July 27, 2026 stated that hypersensitivity reactions were observed in 42% of deramiocel-treated patients versus 15% of placebo-treated patients, and that this "distinctive adverse event profile" raised the possibility that treatment assignment could be inferred even under formal blinding conditions. Reviewers added that the risk of functional unblinding was extended by the open-label period, during which additional treatment-related data accumulated. The lawsuit asserts that investors were never told this risk existed while the Company promoted HOPE-3 as delivering statistically significant results.

Trial Design Risk in Blinding Adequacy

• Hypersensitivity reactions occurred at 42% in the treatment arm compared with 15% on placebo, per FDA briefing materials.
• Regulators indicated that an asymmetric side-effect signal can allow patients, caregivers, or evaluators to infer assignment.
• HOPE-3's open-label extension allowed further treatment-related observations to accumulate, which reviewers said may have made assignment more apparent.
• The action claims the pre-specified blinding plan's process for statistical analysis plan changes was not followed.
• As alleged, the final clinical study protocol (Protocol 9.0) deviated from the associated statistical analysis plan (v. 3.0).
  
  

Why Blinding Adequacy Allegedly Matters to Investors

For a functional endpoint measured by clinicians and caregivers, blinding integrity bears directly on whether reported effects can support approval. On July 30, 2026, following a 9-3 advisory committee vote, media reporting indicated the panel concluded that available evidence does not support the efficacy of deramiocel for DMD-associated cardiomyopathy. The lawsuit asserts that positive Class Period statements about the program lacked a reasonable basis in light of these undisclosed risks.

Learn more about the case or call (888) SueWallSt.

WHY SUEWALLST: SueWallSt is powered by Levi & Korsinsky LLP. Levi & Korsinsky LLP has established itself as a nationally-recognized securities litigation firm that has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. The firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report as one of the top securities litigation firms in the United States.

Frequently Asked Questions About the CAPR Lawsuit

Q: Who is eligible to join the CAPR investor lawsuit? A: Investors who purchased CAPR stock or securities between December 17, 2025 and July 26, 2026 and suffered financial losses may be eligible. Eligibility is based on purchase date and documented losses, not on whether you still hold the shares.

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, trial blinding integrity, and the resulting risk to regulatory approval of deramiocel. When FDA briefing documents and the advisory committee vote became public, 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: 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 jlevi@levikorsinsky.com or (212) 363-7500. No immediate action is required to remain eligible as an absent class member.

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, with 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.

33 Whitehall Street, 27th Floor

New York, NY 10004

jlevi@SueWallSt.com

Tel: (888) SueWallSt

Fax: (212) 363-7171

Attorney Advertising. Prior results do not guarantee similar outcomes.