CAPR Investor Alert: Levi & Korsinsky Notifies Investors of Investigation Into Capricor (CAPR)

The investigation centers on Capricor's market reaction after FDA staff briefing documents challenged Deramiocel's cardiac endpoint and noted a post-randomization change to the trial's statistical analysis plan.

NEW YORK--(BUSINESS WIRE)--Capricor (NASDAQ: CAPR) shares collapsed 60% to 70% on July 27, 2026 after FDA staff briefing documents raised significant concerns regarding the evidence supporting Deramiocel's efficacy ahead of the July 29, 2026 advisory committee meeting. CAPR shareholders who saw their investment drop after the FDA briefing documents are encouraged to act promptly. To respond while the investigation is active, submit your CAPR loss information or contact Levi & Korsinsky, LLP at [phone].

The FDA staff documents stated that Deramiocel had not demonstrated sufficient effectiveness on the heart-disease endpoint. The documents also noted that the trial's statistical analysis plan was changed after the randomized phase. The market reaction was immediate, with CAPR losing roughly two-thirds of its value in the trading reaction.

Levi & Korsinsky is investigating potential securities law violations on behalf of investors who suffered losses in Capricor. The investigation focuses on the FDA staff briefing documents, the July 29 advisory committee setting, and the 60% to 70% stock decline that followed the release of those documents.

If your Capricor investment declined after the FDA briefing documents, request a no-cost loss review. You may also contact Joseph E. Levi, Esq. by telephone at [phone].

ABOUT THE FIRM -- For over two decades, Levi & Korsinsky has represented shareholders in securities class actions. Ranked in ISS Top 50 for seven consecutive years.

Frequently Asked Questions About the CAPR Investigation

Q: How much did CAPR stock drop? A: CAPR shares fell approximately 60% to 70% after FDA staff briefing documents disclosed concerns with Deramiocel's cardiac endpoint and noted a change to the trial's statistical analysis plan after randomization.

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: When did Capricor allegedly mislead investors? A: The investigation concerns statements made before the FDA staff briefing documents were released on July 27, 2026, when CAPR shares fell approximately 60% to 70%.

Q: What do CAPR investors need to do right now? A: Investors should keep brokerage records showing purchase dates, share quantities, prices paid, and any sale dates and sale prices. Those records help evaluate documented losses.

Q: What documents do I need to participate? A: Brokerage statements or trade confirmations showing purchase dates, share quantities, prices paid, and any later sale dates and prices are typically sufficient for an initial evaluation.

Q: What if I already sold my CAPR shares -- can I still recover losses? A: Yes. Eligibility is based on purchase timing and documented losses, not whether you still hold the shares.

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.

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