Capricor Therapeutics, Inc.
capricor.comWhat Do They Do?
Develops cell and exosome-based therapies for patients with Duchenne muscular dystrophy and other diseases, including a cell therapy designed to address cardiac and skeletal muscle complications.
10-K for FY2025, filed Mar 17, 2026Capricor Therapeutics, Inc. is a biotechnology company focused on the development and potential commercialization of cell and exosome-based…View ↗
Our core program is focused on the development and commercialization of Deramiocel, a cell therapy product candidate comprised of…View ↗
Our exosome platform is supported by internal research and external collaborations. Our collaborations and research around exosomes include…View ↗
Who Are Their Customers?
For Deramiocel, Capricor plans commercialization in the United States and may use strategic partners in selected international markets; Nippon Shinyaku is the exclusive distributor in the United States and Japan.
10-K for FY2025, filed Mar 17, 2026
How Are They Changing?
- Net income
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Sources
10-Q for Q2 FY2026, filed Aug 14, 2026
−$40.7MView ↗
- ▲ +57% (Loss)
- vs −$25.9M in Q2 FY2025
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Aug 24, 2026
Food and Drug Administration extends Deramiocel review
The agency moved the target date to November 22, 2026, after classifying additional trial data and analyses as a major amendment.
Sources
8-K, filed Aug 24, 2026
On August 24, 2026, Capricor Therapeutics, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug…View ↗
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Aug 13, 2026
Capricor withdraws its injunction motion against distributor
It plans to pursue the contract dispute in arbitration after the FDA's decision and continues to seek rescission of the U.S. agreement.
Sources
8-K, filed Aug 13, 2026
NS Pharma Dispute: The state court was scheduled to hear Capricor's motion for preliminary injunction on August 10, 2026, ahead of the…View ↗
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Jul 30, 2026
Advisory panel votes against Deramiocel for cardiomyopathy
The committee voted 3 to 9 against Deramiocel for DMD cardiomyopathy; its recommendation is nonbinding.
Sources
8-K, filed Jul 30, 2026
On July 29, 2026, the U.S. Food and Drug Administration's ("FDA") Cellular, Tissue and Gene Therapies Advisory Committee voted that…View ↗
Deramiocel moves toward commercialization
The older report described the DMD cell therapy in a clinical study; the latest report says its application is under FDA review and the company is preparing for possible commercialization.
10-K for FY2022, filed Mar 17, 2023 10-K for FY2025, filed Mar 17, 2026We are currently enrolling the HOPE-3, Phase III clinical study investigating CAP-1002 for the treatment of late-stage DMD patients for the…View ↗
Exosome vaccine enters human testing
The older report described the engineered exosome vaccine as preclinical and said Capricor was seeking partners to move it into human testing; the latest report says a study run by the National Institutes of Health is underway.
10-K for FY2022, filed Mar 17, 2023 10-K for FY2025, filed Mar 17, 2026We are focused on developing a precision-engineered exosome platform technology that has the ability to deliver defined sets of effector…View ↗
We are developing an exosome-based vaccine candidate targeting SARS-CoV-2 using our exosome platform technology. This program is currently…View ↗
Who Do They Compete With?
Competes with Sarepta Therapeutics, Nippon Shinyaku, and NS Pharma
10-K for FY2025, filed Mar 17, 2026Several exon-skipping therapies have been approved by the FDA for the treatment of certain subsets of patients with DMD who have specific…View ↗
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