From Optimism to Disillusionment: Capricor Therapeutics investors watched sentiment collapse from confidence in an August 22, 2026 approval date to a 78.7% share decline after FDA briefing documents allegedly surfaced undisclosed statistical analysis plan changes.

NEW YORK, Aug. 19, 2026 /PRNewswire/ — Levi & Korsinsky, LLP provides context on investor sentiment surrounding Capricor Therapeutics, Inc. (NASDAQ: CAPR) and notifies shareholders that a securities class action has been filed on behalf of investors who purchased CAPR securities between December 17, 2025 and July 26, 2026. Find out if you could qualify to recover your per-share losses. You may also contact Joseph E. Levi, Esq. at jlevi@levikorsinsky.com or (212) 363-7500.

CAPR shares fell to $4.19 per share on July 30, 2026, after closing at a Class Period high of $35.34 on April 21, 2026. The drop unfolded across two sessions: a $12.70 decline (64%) on July 27, 2026, followed by a $2.38 decline (36%) on July 30, 2026, each on unusually heavy trading volume. LEAD PLAINTIFF DEADLINE: September 28, 2026.

The Early Optimism

Sentiment reflected confidence heading into mid-2026. Investors had a PDUFA target action date of August 22, 2026, publicly reported p-values of 0.03 on the HOPE-3 primary endpoint and 0.04 on the key secondary cardiac endpoint, and Company statements describing commercial launch preparations already underway. The complaint alleges that shareholders were not told that the final statistical analysis plan (v. 3.0), dated November 24, 2025, had not been submitted to or agreed upon by FDA before the BLA resubmission.

The Breaking Point

Investors reportedly expressed shock on July 27, 2026, when FDA briefing documents stated the study “did not meet its pre-specified primary and secondary efficacy endpoints,” that the final SAP was created one day before unblinding, and that the agency “considers [Capricor’s] analyses based on the post-study SAP versions to be post-hoc and exploratory.” Cantor Fitzgerald wrote the same day that the documents “paint an ugly picture.” On July 30, 2026, reporting indicated the advisory committee voted 9-3 that available evidence does not support efficacy of deramiocel for DMD-associated cardiomyopathy.

The Sentiment Shift

• Pre-disclosure: PDUFA target action date of August 22, 2026 treated as a near-term catalyst
• July 27, 2026: shares close at $7.00 after FDA briefing documents
• July 30, 2026: shares close at $4.19 following the 9-3 advisory committee vote
• Total measured decline: an aggregate $15.08 per share, or 78.7% across two corrective disclosures
• Hypersensitivity reactions reported in 42% of treated patients versus 15% on placebo, which FDA linked to possible functional unblinding
• Two consecutive sessions of unusually heavy trading volume as sentiment reversed

“When companies fail to disclose material information, shareholders may suffer significant losses. Here, the complaint alleges investors learned only from FDA briefing documents that the final statistical analysis plan had not been agreed upon by the agency.” — Joseph E. Levi, Esq.

Submit your information here or call (212) 363-7500.

ABOUT LEVI & KORSINSKY, LLP — Over the past 20 years, Levi & Korsinsky has secured hundreds of millions of dollars for aggrieved shareholders. The firm has extensive expertise in complex securities litigation and a team of over 70 employees. For seven consecutive years, Levi & Korsinsky has ranked in ISS Securities Class Action Services’ Top 50 Report. Investors who suffered losses have until September 28, 2026 to seek appointment as lead plaintiff.

Frequently Asked Questions About the CAPR Lawsuit

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: When did Capricor Therapeutics allegedly mislead investors? A: The Class Period runs from December 17, 2025 to July 26, 2026. The complaint alleges that corrective disclosures revealed information that caused a significant stock decline.

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 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: 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.

Ed Korsinsky, Esq.

33 Whitehall Street, 27th Floor

New York, NY 10004

jlevi@levikorsinsky.com

Tel: (212) 363-7500

Fax: (212) 363-7171

Attorney Advertising. Prior results do not guarantee similar outcomes.

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