FiledJun 26, 2026 - 5:15 PM ET

CAPRCAPRICOR THERAPEUTICS, INC.Nasdaq

FDA Advisory Committee Meeting Scheduled for Deramiocel BLA Review

8-KFDA / ClinicalvolatileImpact75

CAPR Price

Chart unavailable

N/A$0.00 (+0.00%)

Chart unavailable

Filing Brief

Capricor Therapeutics announced an FDA Advisory Committee meeting for its Duchenne muscular dystrophy therapy, Deramiocel, ahead of an August PDUFA date

Product / Regulatory Snapshot

Therapy: DeramiocelInvestigational cell therapy
Indication: Duchenne muscular dystrophy (DMD)
Advisory Committee Meeting: July 29, 2026To discuss BLA approval
PDUFA Target Action Date: August 22, 2026

Summary

Add Stock Radar as a preferred source on GoogleAdd Stock Radar on Google

Capricor Therapeutics announced that the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee will meet on July 29, 2026, to review the Biologics License Application (BLA) for Deramiocel, its investigational cell therapy for Duchenne muscular dystrophy (DMD). The company confirmed that the BLA remains on track for a Prescription Drug User Fee Act (PDUFA) target action date of August 22, 2026. This upcoming meeting and PDUFA date represent significant near-term regulatory catalysts for the company's lead product candidate

Score75

Score Rationale

volatile

The scheduled FDA Advisory Committee meeting and confirmed PDUFA date for Deramiocel represent a critical, time-sensitive regulatory milestone for Capricor Therapeutics.

Key FDA Review Details

Key terms

BLA Support: Phase 2 HOPE-2, HOPE-2-OLE, Phase 3 HOPE-3 trialsPhase 3 achieved statistical significance on primary and key secondary endpoints
Designations: Orphan Drug, RMAT, ATMP, Rare Pediatric DiseaseMay qualify for Priority Review Voucher
Mechanism of Action: Allogeneic cardiosphere-derived cells (CDCs)Exert immunomodulatory and anti-fibrotic actions

AdvertisementResponsive display

CAPR Market Context

SectorHealthcare

IndustryBiotechnology

Market Cap$983.37M

Shares Outstanding45.72M

Public Float37.8M

Public Float %82.7%

AdvertisementResponsive display

Original Filing Text

SEC filing text preserved from the raw item store.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported)

June 26, 2026

CAPRICOR THERAPEUTICS, INC.

(Exact name of Registrant as Specified in its Charter)


Delaware		001-34058		88-0363465
(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification No.)


10865 Road to the Cure, Suite 150, San Diego, California (Address of principal executive offices)		92121 (Zip Code)

(858) 727-1755

(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ◻

Securities registered pursuant to Section 12(b) of the Act:


Title of Each Class		Trading Symbol(s)		Name of Each Exchange on Which Registered
Common Stock, par value $0.001 per share		CAPR		The Nasdaq Global Select Market

Item 8.01Other Events.

On June 26, 2026, Capricor Therapeutics, Inc. (the “Company” or “Capricor”) issued a press release announcing that the Cellular, Tissue, and Gene Therapies Advisory Committee of the U.S. Food and Drug Administration (“FDA”) is planning to convene an Advisory Committee meeting to discuss the Company's Biologics License Application (“BLA”) seeking approval of Deramiocel, an investigational cell therapy for the treatment of Duchenne muscular dystrophy (“DMD”). The date for the Advisory Committee meeting is July 29, 2026, and the meeting will be available for live streaming. The Company's BLA remains on track for a target action date under the Prescription Drug User Fee Act (“PDUFA”) of August 22, 2026.

A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01Financial Statements and Exhibits.

(d) Exhibits


99.1		Press Release, titled “Capricor Therapeutics Announces FDA Advisory Committee Meeting to Review BLA for Deramiocel for the Treatment of Duchenne Muscular Dystrophy”, dated June 26, 2026.

104		Cover Page Interactive Data File (formatted as inline XBRL).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.


	CAPRICOR THERAPEUTICS, INC.

Date: June 26, 2026	By:	/s/ Linda Marbán, Ph.D.
		Linda Marbán, Ph.D.
		Chief Executive Officer