NEW YORK, July 30, 2026 (GLOBE NEWSWIRE) — Lowey Dannenberg P.C., a preeminent law firm in obtaining redress for consumers and investors, is investigating Capricor Therapeutics, Inc. (NASDAQ: CAPR) (“Capricor” or the “Company”) for potential violations of the federal securities laws.
On July 27, 2026, ahead of a July 29, 2026 meeting of the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee convened to review Capricor’s Biologics License Application (“BLA”) for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (“DMD”), Capricor disclosed that the FDA’s briefing materials relied on a superseded statistical analysis – Statistical Analysis Plan (“SAP”) version 1.1 – which the Company described as an unsigned, incomplete internal draft that predated the addition of a study cohort and omitted content the FDA had requested, rather than the final SAP version 3.0 that Capricor says governed its reported Phase 3 HOPE-3 trial results. Following this news, the price of Capricor stock fell approximately 64%, wiping out hundreds of millions of dollars in shareholder value.
Then, on July 30, 2026, Capricor announced that the FDA Advisory Committee had voted 3 in favor and 9 against finding that the available evidence supports the effectiveness of Deramiocel for treating cardiomyopathy in DMD. Although the vote is non-binding and addressed a narrower cardiomyopathy indication than Capricor had proposed, it raised new doubts about the BLA ahead of the FDA’s August 22, 2026 PDUFA target action date, and follows a stock decline that has already cost investors significant losses.
“Our investigation concerns whether the company and its executives provided investors with accurate and complete information about the company,” said attorney Andrea Farah, Lowey Dannenberg, P.C. partner and head of the firm’s securities practice.
If you suffered a loss in Capricor securities, and wish to participate, or learn more about your eligibility, contact our attorneys Andrea Farah (afarah@lowey.com) at (914) 733-7256 or Vincent R. Cappucci Jr. (vcappucci@lowey.com) at (914) 733-7278.
About Lowey Dannenberg
Lowey Dannenberg is a national firm representing institutional and individual investors, who suffered financial losses resulting from corporate fraud and malfeasance in violation of federal securities and antitrust laws. The firm has significant experience in prosecuting multi-million-dollar lawsuits and has previously recovered billions of dollars on behalf of investors.
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SOURCE: Lowey Dannenberg
