Wall Street’s view of Capricor Therapeutics reversed within hours after FDA briefing documents allegedly exposed unagreed changes to the HOPE-3 statistical analysis plan, with analysts questioning data integrity as CAPR shares fell 78.7%.

NEW YORK, Aug. 5, 2026 /PRNewswire/ — Levi & Korsinsky, LLP alerts investors in Capricor Therapeutics, Inc. (NASDAQ: CAPR) that a securities class action has been filed 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@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 came in two steps: $12.70 (64%) on July 27, 2026 to close at $7.00, then $2.38 (36%) on July 30, 2026. The lead plaintiff deadline is September 28, 2026.

Sell-Side Confidence Before July 27

Coverage indicated a constructive setup heading into the FDA advisory committee meeting. The Company had reported HOPE-3 primary endpoint significance at p=0.03 and a key secondary cardiac endpoint at p=0.04, and had announced a PDUFA target action date of August 22, 2026. Analysts noted that the Company had described the FDA as having identified no potential review issues at the time review resumed.

The Note That Changed the Narrative

On July 27, 2026, Cantor Fitzgerald published an investor note stating that the FDA’s “briefing documents paint an ugly picture” and “raise several concerns and make allegations about the integrity of data collecting.” The complaint alleges that the briefing documents disclosed that the final statistical analysis plan (v. 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 FDA therefore considered the analyses “post-hoc and exploratory.”

Analyst Coverage Timeline

• Pre-July 27: Coverage framed HOPE-3 as statistically significant on both primary and key secondary endpoints.
• July 27, pre-market: FDA briefing documents state the benefit-risk assessment “appears unfavorable in the absence of evidence of effectiveness.”
• July 27, same day: Cantor Fitzgerald flags concerns regarding “the integrity of data collecting.”
• July 29: The advisory committee convenes on the Deramiocel BLA.
• July 30: Medscape reports a 9-3 non-binding vote concluding available evidence does not support efficacy for DMD-associated cardiomyopathy.

“When analyst expectations are built on incomplete or misleading company disclosures, the resulting corrections can cause significant investor harm. Here, the complaint alleges that Wall Street’s models rested on efficacy claims the FDA later characterized as post-hoc and exploratory.” — Joseph E. Levi, Esq.

Learn more about the case or call (212) 363-7500.

WHY LEVI & KORSINSKY — Ranked in ISS Securities Class Action Services’ Top 50 Report for seven consecutive years, Levi & Korsinsky, LLP is a nationally recognized leader in shareholder rights litigation. With a team of over 70 professionals, the firm has recovered hundreds of millions of dollars for investors. Investors who suffered losses have until September 28, 2026 to seek appointment as lead plaintiff.

Frequently Asked Questions About the CAPR Lawsuit

Q: What is the CAPR class action lawsuit about? A: A securities class action has been filed against Capricor Therapeutics, Inc. (NASDAQ: CAPR) alleging materially false and misleading statements between December 17, 2025 and July 26, 2026. Shares fell approximately 78.7% after FDA briefing documents disclosed unagreed changes to the pre-specified statistical analysis plan for the HOPE-3 trial and an advisory committee voted 9-3 against efficacy support. Investors who purchased shares during the Class Period and suffered losses may be eligible to seek compensation.

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 specific misstatements does the CAPR lawsuit allege? A: The complaint alleges Capricor made materially false or misleading statements regarding the statistical basis for HOPE-3 efficacy claims and the likelihood of regulatory approval, without disclosing that the final statistical analysis plan was changed without FDA agreement. When the FDA briefing documents were released, 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 jlevi@levikorsinsky.com 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.

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

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SOURCE Levi & Korsinsky, LLP