San Diego – October 19, 2026 -- The U.S. Food and Drug Administration's Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) will meet on July 29, 2026, to review Capricor Therapeutics' Biologics License Application (BLA) for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD), less than four weeks before the agency's August 22, 2026 PDUFA target action date.

San Diego – October 19, 2026 -- Capricor Therapeutics (NASDAQ: CAPR) disputed the post-hoc analyses in the FDA's briefing materials, two days before an advisory committee meets on July 29 to discuss its Biologics License Application (BLA) for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD).

San Diego – October 19, 2026 -- Capricor Therapeutics (NASDAQ: CAPR) said The Lancet has published results from its Phase 3 HOPE-3 trial, in which Deramiocel slowed upper limb function decline by 54 percent versus placebo in Duchenne muscular dystrophy (PUL 2.0, p=0.03).

The randomized, double-blind, placebo-controlled trial enrolled 106 participants and met its primary endpoint. Capricor also reports a clinically meaningful cardiac benefit. The results rest on the company's prespecified Statistical Analysis Plan version 3.0 (SAP 3.0).

SAN DIEGO – October 19, 2026 -- The FDA's Cellular, Tissue and Gene Therapies Advisory Committee voted 9-3, with no abstentions, that available evidence did not support the effectiveness of Capricor Therapeutics' Deramiocel for cardiomyopathy in patients with Duchenne muscular dystrophy (DMD), leaving the company's PDUFA target action date of August 22, 2026 as the next decision point.

San Diego – October 19, 2026 -- Capricor Therapeutics (NASDAQ: CAPR) ended the second quarter with about $237.9 million in cash, cash equivalents and marketable securities, down from about $318.1 million at Dec. 31, 2025. The decline came as an FDA advisory committee voted 9 against and 3 in favor on whether evidence shows Deramiocel is effective for cardiomyopathy in Duchenne muscular dystrophy (DMD) patients.

San Diego – October 19, 2026 -- The U.S. Food and Drug Administration has pushed the decision date for Capricor Therapeutics' Deramiocel Biologics License Application by three months, from August 22, 2026 to November 22, 2026, after classifying the company's latest data submission as a major amendment.

Deramiocel is an investigational cell therapy for Duchenne muscular dystrophy (DMD). Capricor (NASDAQ: CAPR) disclosed the extension of the Prescription Drug User Fee Act (PDUFA) target action date on the day of release.

San Diego – October 19, 2026 -- Capricor Therapeutics (NASDAQ: CAPR) will present 24-month skeletal muscle and cardiac data from its Phase 3 HOPE-3 trial of Deramiocel in Duchenne muscular dystrophy (DMD) at the World Muscle Society Congress, weeks ahead of an FDA PDUFA target action date of November 22, 2026.

The 31st Annual Congress (WMS 2026) runs September 29 to October 3, 2026, in Hiroshima, Japan. Capricor will deliver one late-breaking poster and one oral presentation on Deramiocel, plus two preclinical posters from its StealthX exosome platform.

San Diego – October 19, 2026 -- Capricor Therapeutics (NASDAQ: CAPR) reported that Duchenne muscular dystrophy patients who switched from placebo to Deramiocel after one year slowed their upper limb decline by 76% compared with their own prior year, according to open-label extension data from the Phase 3 HOPE-3 trial. The U.S. FDA has set a PDUFA target action date of November 22, 2026, for the therapy.

New York – September 10, 2026 -- Capricor Therapeutics, Inc. (NASDAQ:CAPR) faces a securities fraud class action after its shares plunged 64.5% following disclosures about alleged undisclosed changes to clinical trial statistics underlying its Duchenne muscular dystrophy therapy application.

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.