FDA lifts deramiocel CRL, resumes BLA review
- Sponsor
- Capricor Therapeutics $CAPR
- Drug
- deramiocel
FDA lifted its previously issued Complete Response Letter for Capricor Therapeutics' deramiocel BLA and accepted the resubmission as a Class 2 with a PDUFA target action date of August 22, 2026.
What this means
Deramiocel is an investigational cell therapy that uses cardiac progenitor cells to potentially slow heart damage in Duchenne muscular dystrophy. After an earlier setback last year — the FDA had asked Capricor for more information before approving — the agency has now lifted that hold and restarted its review. A new decision is expected by August 22, 2026, giving families and clinicians a clearer timeline for when this therapy might become available.
From the source
Item 7.01 Regulation FD Disclosure.
On March 10, 2026, Capricor Therapeutics, Inc. (the "Company" or "Capricor") issued a press release announcing that the U.S. Food and Drug Administration ("FDA") has lifted the previously issued Complete Response Letter ("CRL") and resumed review of its Biologics License Application ("BLA") seeking full approval of Deramiocel, an investigational cell therapy, for the treatment of Duchenne muscular dystrophy ("DMD") cardiomyopathy.
A copy of the press release is attached as Exhibit 99.1 hereto and is incorporated herein by reference.
Item 8.01 Other Events.
As disclosed above, the FDA has lifted the previously issued CRL and resumed review of the Company's BLA seeking full approval of Deramiocel, an investigational cell therapy, for the treatment of DMD cardiomyopathy. The submission has been classified as a Class 2 resubmission, with a Prescription Drug User Fee Act ("PDUFA") target action date of August 22, 2026.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
99.1 Press Release, titled "Capricor Therapeutics Announces Establishment of New PDUFA Date for Deramiocel BLA", dated March 10, 2026.
Reproduced from SEC EDGAR 8-K (material event) · view original · public domain or open-licensed government work