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Deramiocel

Capricor Therapeutics Faces Securities Fraud Suit Over Deramiocel BLA

Los Angeles – September 10, 2026 -- Schall, Brown & Schwartz LLP (SBS) has issued a reminder to shareholders of Capricor Therapeutics, Inc. (NASDAQ: CAPR) of a securities class action lawsuit alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934. The lead plaintiff deadline is set for September 28, 2026.

Lawsuit covers CAPR shares purchased between December 17, 2025 and July 26, 2026

The class action targets investors who purchased Capricor shares during this roughly seven-month window. Appointment as lead plaintiff is not a prerequisite for shareholders to participate in any eventual recovery.

Capricor Investors Face Sept. 28 Deadline as FDA Delays Deramiocel Ruling

Capricor Investors Face Sept. 28 Deadline as FDA Delays Deramiocel Ruling

San Francisco – September 10, 2026 -- Investors in Capricor Therapeutics, Inc. (NASDAQ: CAPR) have until September 28, 2026, to seek lead plaintiff status in a securities class action tied to the company's Duchenne muscular dystrophy therapy, deramiocel, as the FDA extends its review timeline.

FDA pushes deramiocel decision to November 22, 2026

On August 24, 2026, Capricor disclosed that the FDA extended the PDUFA target action date for its lead cell therapy deramiocel from August 22, 2026, to November 22, 2026. The agency classified the company's post-Advisory Committee submission as a major amendment, which included 24-month open-label extension data from the Phase 3 HOPE-3 study and a bid to narrow the therapy's indication to upper limb function.