Capricor Therapeutics因HOPE-3试验统计分析计划披露问题遭证券集体诉讼

A securities class action alleges Capricor Therapeutics failed to disclose that it changed the pre-specified statistical analysis plan for its Phase 3 HOPE-3 trial without FDA agreement, leaving results the agency characterized as "post-hoc and exploratory."
NEW YORK, Aug. 26, 2026 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Capricor Therapeutics, Inc. (NASDAQ: CAPR) that a class action lawsuit has been filed on behalf of shareholders who purchased securities between December 17, 2025 and July 26, 2026. Find out if you could qualify to recover your losses. You may also contact Joseph E. Levi, Esq. at [email protected] or (212) 363-7500.
CAPR shares lost approximately 78.7% of their value across two trading sessions in late July 2026. One day, that is the interval between the dating of the final statistical analysis plan (v. 3.0) and the unblinding of the HOPE-3 data, according to the lawsuit.
The Alleged Statistical Analysis Plan Methodology
HOPE-3 was a randomized, double-blind, placebo-controlled 12-month study in 106 patients with Duchenne muscular dystrophy. The complaint alleges that after the blinded portion concluded, changes were made to the pre-specified statistical analysis plan, generating at least two additional versions, and that those changes altered primary and key secondary endpoint definitions, the analytical methods, and the data imputation strategy for certain intercurrent events. The lawsuit contends the final version was never submitted to the FDA for review before the BLA was filed and was never agreed upon.
How the Alleged Statistical Changes Affected Reported Results
Management told the market that HOPE-3 delivered statistically significant results, with p=0.03 on the primary endpoint and p=0.04 on the key secondary cardiac endpoint. FDA briefing documents released July 27, 2026 stated the study "did not meet its pre-specified primary and secondary efficacy endpoints showing no statistically significant difference," and that the benefit-risk assessment "appears unfavorable in the absence of evidence of effectiveness."
Key Statistical Analysis Plan Allegations for Shareholders
- The final SAP (v. 3.0), dated November 24, 2025, was allegedly not discussed with or agreed upon by the FDA
- The FDA stated it does not consider converting raw change to percent change and back to raw change to be scientifically justified
- The agency characterized analyses based on post-study SAP versions as "post-hoc and exploratory"
- The final clinical study protocol (Protocol 9.0) allegedly deviated from the associated SAP
- An advisory committee voted 9-3 that available evidence does not support deramiocel's efficacy
"This case presents important questions about statistical analysis plan disclosure obligations in the biotechnology sector, including when a company must tell investors that regulators have not agreed to changes underpinning reported efficacy," -- Joseph E. Levi, Esq.
Submit your information here or call (212) 363-7500. Applications to serve as lead plaintiff must be filed by September 28, 2026.
WHY LEVI & KORSINSKY: Over the past 20 years, 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 made materially false or misleading statements regarding changes to the pre-specified statistical analysis plan for HOPE-3 and the resulting risk to regulatory approval of 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 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 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.\
Ed Korsinsky, Esq.\
33 Whitehall Street, 27th Floor\
New York, NY 10004\
[email protected]\
Tel: (212) 363-7500\
Fax: (212) 363-7171
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SOURCE Levi & Korsinsky, LLP