CAPR shareholders saw a 60% to 70% drop after FDA briefing documents identified significant concerns regarding Deramiocel’s efficacy and regulatory prospects. The investigation focuses on whether Capricor adequately disclosed material risks related to the FDA review process and Deramiocel’s efficacy.

NEW YORK, Aug. 5, 2026 /PRNewswire/ — Capricor Therapeutics, Inc. (NASDAQ: CAPR) shareholders were hit with a 60% to 70% drop on July 27, 2026, after FDA briefing documents for Deramiocel raised significant concerns with cardiac efficacy and a post-randomization statistical analysis plan change. If that collapse reduced the value of your CAPR position, action may be needed now. CAPR investors who suffered losses are encouraged to send your loss information now .

The FDA briefing documents were released ahead of the July 29, 2026 advisory committee meeting. FDA staff stated that Deramiocel had not demonstrated sufficient effectiveness on the cardiac endpoint and described a statistical analysis plan change after randomization. CAPR shares fell sharply the same day.

Before the drop, Capricor had framed the FDA review and cardiac data in positive terms. On March 12, 2026, CEO Linda Marbán said the FDA had not identified potential review issues in communications with the Company. On May 7, 2026, Capricor stated that Deramiocel slowed cardiac decline by approximately 91% compared to placebo with statistical significance.

The investigation concerns potential securities law violations tied to Capricor’s statements about FDA review status, cardiac efficacy, and the Deramiocel advisory committee process.

CAPR shareholders who suffered losses are encouraged to provide their information for review . You may also call (212) 363-7500. Levi & Korsinsky, LLP | Top 50 Securities Firm | (212) 363-7500 | www.zlk.com

Frequently Asked Questions About the CAPR Investigation

Q: Which statements are being investigated as potentially misleading?  A: The investigation concerns whether Capricor made materially false or misleading statements regarding Deramiocel’s cardiac efficacy, including statements that the therapy slowed cardiac decline by approximately 91% compared to placebo with statistical significance.

Q: Who is eligible to participate in the CAPR investigation?  A: Investors who purchased CAPR stock or securities and suffered financial losses may be eligible. Eligibility is based on transaction records and documented losses — not on whether the investor still holds the shares.

Q: When did Capricor allegedly mislead investors?  A: The investigation focuses on statements made before the July 27, 2026 FDA staff briefing documents, including statements about cardiac efficacy, FDA communications, and the Deramiocel review process.

Q: What documents do I need to participate?  A: Brokerage statements or trade confirmations showing purchase dates, share quantities, prices paid, and any subsequent sale dates and prices.

Q: What is a lead plaintiff and why does it matter?  A: If the investigation proceeds to legal action, a lead plaintiff is the investor a court appoints to represent affected investors. Lead plaintiffs are typically investors with the largest documented losses who are willing to represent the group.

Q: What if I already sold my CAPR shares — can I still recover losses?  A: Yes. Eligibility is based on when the shares were purchased and whether losses were suffered. Investors who bought CAPR and later sold at a loss may still be eligible to participate in the investigation.

Q: What does it cost me to participate?  A: There is no upfront cost to participate. Securities investigations and any resulting actions are generally handled on a contingency basis, with no upfront fees, no retainer, and no out-of-pocket costs.

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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SOURCE Levi & Korsinsky, LLP