Capricor investors lost 60% to 70% after FDA briefing documents raised significant concerns regarding Deramiocel, following earlier Company statements that the FDA had not identified material review issues.
NEW YORK , July 30, 2026 /PRNewswire/ -- FDA staff briefing documents released on July 27, 2026 sent Capricor (NASDAQ: CAPR) shares down 60% to 70% after reviewers raised significant concerns with Deramiocel ahead of the July 29 advisory committee meeting. If your CAPR shares fell on this FDA briefing news, your losses may be part of the pending investigation. CAPR shareholders who suffered losses are encouraged to submit your CAPR loss information .
SueWallSt is reviewing potential securities law violations tied to Capricor's regulatory-status statements before the July 27 decline. On March 12, 2026, CEO Linda Marbán told investors: "The FDA has not identified any potential review issues in its communication to the company, which we view as encouraging."
On May 13, 2025, Marbán also stated: "We do not believe, nor has FDA signaled, that the determination to hold an advisory committee has anything to do with weaknesses in the application."The July 27 FDA briefing documents stated that Deramiocel had not demonstrated statistically significant benefit on its pre-specified cardiac endpoint and noted that the statistical analysis plan had been modified after unblinding. CAPR shares reacted immediately, falling 60% to 70% the same day.
CAPR investors who lost money may request a free loss review or call (888) SueWallSt.
WHY SUEWALLST : SueWallSt is powered by Levi & Korsinsky LLP. 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 Investigation
Q: What is the CAPR investigation about? A: The investigation concerns Capricor Therapeutics (NASDAQ: CAPR) and statements about Deramiocel, including its cardiac endpoint and FDA review status. Shares fell 60% to 70% on July 27, 2026, after FDA staff briefing documents raised concerns regarding whether Deramiocel demonstrated substantial evidence of effectiveness and noted changes to the statistical analysis plan after unblinding.
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 to participate. Eligibility depends on purchase timing and documented losses -- not whether you still hold the shares.
Q: How much did CAPR stock drop? A: Capricor shares fell approximately 60% to 70% on July 27, 2026 after FDA staff briefing documents described significant concerns with Deramiocel ahead of the July 29 advisory committee meeting.
Q: Which statements are being reviewed? 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: What do CAPR investors need to do right now? A: Investors should gather brokerage records showing purchase dates, share quantities, prices paid, and any sale dates and sale prices. Those records are used to evaluate documented losses.
Q: What documents do I need to participate? A: Brokerage statements or trade confirmations showing CAPR purchase dates, share quantities, prices paid, and any later sale dates and prices.
Q: What if I already sold my CAPR shares -- can I still recover losses? A: Yes. Eligibility is based on when you purchased and whether you suffered losses, not whether you still hold the shares.
Q: What if my CAPR losses are small -- is it still worth contacting a lawyer? A: Yes. There is no minimum loss amount required 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 recovery efforts are generally handled on a contingency basis. No upfront fees, no retainer, and no out-of-pocket costs.
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Joseph E. Levi, Esq.
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