CAPRICOR THERAPEUTICS, INC. 8-K

What Happened

• Capricor Therapeutics (CAPR) announced on March 10, 2026, that the U.S. Food and Drug Administration (FDA) has lifted a previously issued Complete Response Letter (CRL) and resumed review of the company’s Biologics License Application (BLA) for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD) cardiomyopathy. The resubmission is classified as a Class 2 resubmission with a Prescription Drug User Fee Act (PDUFA) target action date of August 22, 2026. The company attached a press release as Exhibit 99.1 to the Form 8-K.

Key Details

• Product: Deramiocel (investigational cell therapy) for DMD cardiomyopathy.
• Regulatory status: FDA lifted prior CRL and resumed BLA review; submission is a Class 2 resubmission.
• Timeline: PDUFA target action date set for August 22, 2026.
• Filing notes: Form 8-K includes the press release and standard forward-looking statement caution; report signed by CEO Linda Marbán, Ph.D.

Why It Matters

• The FDA resuming review and the new PDUFA date give investors a clear regulatory timeline for potential full approval of Deramiocel, which could materially affect Capricor’s prospects if approved.
• Classification as a Class 2 resubmission and the lifted CRL indicate the company addressed prior FDA issues sufficiently to restart review, but the outcome and timing remain subject to the FDA’s decision by the August 22, 2026 target.
• The filing also highlights that forward-looking statements in the release are subject to risks and uncertainties described in Capricor’s SEC filings.