Capricor Therapeutics, Inc. filed a Form 8-K on August 24, 2026, disclosing that the FDA extended the PDUFA target action date for its Deramiocel Biologics License Application from August 22, 2026 to November 22, 2026, after classifying a recent submission as a major amendment.

Key Highlights

  • PDUFA date extended: The FDA moved the target action date for the Deramiocel BLA from August 22, 2026 to November 22, 2026, a three-month extension.
  • Major amendment classification: The FDA classified the submission as a major amendment, which extends the review period by three months.
  • New data included: The amendment includes 24-month open-label extension data from Capricor's pivotal Phase 3 HOPE-3 study.
  • Refined indication requested: The amendment includes a request for FDA review of existing and new data in support of a refined proposed indication focused on upper limb function, the primary endpoint of HOPE-3.
  • Indication: Deramiocel is described as an investigational cell therapy for Duchenne muscular dystrophy (DMD).

FDA Extends Deramiocel BLA Review Period by Three Months

According to the filing, Capricor Therapeutics (NASDAQ:CAPR) disclosed on August 24, 2026 that the FDA extended the PDUFA target action date for Deramiocel's Biologics License Application from August 22, 2026 to November 22, 2026. The company reported that the FDA classified the relevant submission as a major amendment, which under agency procedures extends the review period by three months.

The filing states that the amendment includes 24-month open-label extension data from Capricor's pivotal Phase 3 HOPE-3 study, along with additional analyses. The company also indicated it submitted a request for the FDA to review the existing and new data in support of a refined proposed indication focused on upper limb function, which the filing identifies as the primary endpoint of the HOPE-3 study.

The disclosure was made under Item 8.01 (Other Events) of the Form 8-K. The company attached a press release, titled "Capricor Therapeutics Announces Extension of PDUFA Target Action Date as FDA Continues Review of Deramiocel BLA," dated August 24, 2026, as Exhibit 99.1. The filing was signed by Linda Marban, Ph.D., Chief Executive Officer of Capricor Therapeutics, Inc.

What Was Disclosed

Capricor Therapeutics disclosed via an 8-K that the FDA extended the Deramiocel BLA PDUFA date by three months to November 22, 2026, citing a major amendment classification that included new Phase 3 open-label extension data and a request for a refined indication review.