A securities class action alleges Capricor Therapeutics did not follow the pre-specified blinding and protocol procedures for its Phase 3 HOPE-3 trial, with FDA later noting that the final study protocol deviated from the associated statistical analysis plan.

NEW YORK, Aug. 13, 2026 /PRNewswire/ — SueWallSt notifies investors in Capricor Therapeutics, Inc. (NASDAQ: CAPR) that a class action has been filed on behalf of shareholders who purchased securities between December 17, 2025 and July 26, 2026. Find out if you might qualify for recovery. You may also contact Joseph E. Levi, Esq. at jlevi@SueWallSt.com 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. Motions for lead plaintiff must be filed with the Court by September 28, 2026.

The Alleged Protocol and Blinding Plan Deviations

HOPE-3 was designed as a randomized, double-blind, placebo-controlled 12-month study in 106 patients with Duchenne muscular dystrophy. As pleaded, the process for statistical analysis plan changes outlined in the study’s own pre-specified blinding plan was not followed, and the final clinical study protocol (Protocol 9.0) deviated from the associated SAP (v. 3.0). The action contends investors were never told that the final SAP, dated November 24, 2025, was created one day before data unblinding and was not submitted to or agreed upon by FDA prior to the BLA resubmission.

Alleged Trial Conduct Failures in the Record

• Changes to the pre-specified SAP generated at least two additional versions after completion of the double-blind portion of the study.
• Those changes allegedly modified primary and key secondary endpoint definitions, analytical methods, and the data imputation strategy for certain intercurrent events.
• FDA noted final analyses in the BLA submission included additional statistical changes without an associated, updated SAP.
• 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 occurred in 42% of deramiocel-treated patients versus 15% of placebo patients, which FDA said raises the possibility treatment assignment could be inferred even under formal blinding.
• FDA characterized the resulting analyses as post-hoc and exploratory, and said the benefit-risk assessment appeared unfavorable in the absence of evidence of effectiveness.

What Shareholders Were Allegedly Not Told

Plaintiffs allege the Company’s public messaging emphasized statistically significant results (p=0.03 primary; p=0.04 secondary) and an August 22, 2026 PDUFA target date while the underlying trial-conduct issues remained undisclosed. Following the July 27, 2026 release of FDA briefing documents and a 9-3 advisory committee vote against efficacy support, shares declined sharply.

“The complaint raises serious questions about whether investors received accurate information regarding how the HOPE-3 statistical analysis plan was finalized. Allegations that a pre-specified blinding process was not followed, if proven, would be material to any investor evaluating a pending BLA.” — Joseph E. Levi, Esq.

Submit your information now 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 conduct, and the resulting likelihood of regulatory approval for deramiocel. When FDA briefing documents characterized the analyses as post-hoc and exploratory, 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 SueWallSt, a brand of Levi & Korsinsky LLP, for a no-cost, no-obligation evaluation at jlevi@levikorsinsky.com or (212) 363-7500. No immediate action is required to remain eligible to participate in the investigation.

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 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: 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

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