Capricor Therapeutics Reports Third Quarter 2026 Financial Results and Provides Corporate Update
Key Highlights
- ➤PDUFA target date November 22, 2026, after FDA accepted major BLA amendment
- ➤Two-year HOPE-3 data showed 76% slower upper-limb decline after placebo patients switched to Deramiocel
- ➤Cash, equivalents, restricted cash and marketable securities totaled approximately $198.5 million
- ➤Third-quarter operating expenses rose to approximately $44.7 million from $26.3 million
- ➤Third-quarter net loss widened to approximately $42.7 million, or $0.73 per share
Expert Statements
Linda Marbán, Chief Executive Officer of Capricor Therapeutics
“This quarter, we took important steps forward on both our regulatory filing and our launch readiness, submitting two-year HOPE-3 OLE data in a major amendment to our BLA while advancing our manufacturing and commercial preparations. In the OLE phase, patients who switched from placebo to Deramiocel saw their upper limb decline slow by 76% compared with their year on placebo, and this past weekend our HOPE-3 cardiac results received the AHA Outstanding Research Award in Pediatric Cardiology. As Duchenne progresses, boys and young men lose the use of their arms and hands, and with it their independence, which is what Deramiocel is designed to slow. We appreciate the FDA’s engagement throughout this review and are encouraged by the Agency’s current focus on rare disease, including its recently launched Rare Disease Framework Initiative. As we approach our PDUFA date, we remain confident in the strength of our data. With our San Diego facility operational, we are prepared to move quickly to bring Deramiocel to patients, if approved,”
Jonathan Soslow, M.D., MSCI, Vanderbilt University Medical Center
“Results showing slower progression of myocardial fibrosis (heart muscle scarring) with Deramiocel versus placebo and, in patients with cardiomyopathy, left ventricular ejection fraction favoring Deramiocel.”
* Deramiocel Biologics License Application (BLA) for Duchenne muscular dystrophy (DMD) under FDA review; PDUFA target action date of November 22, 2026 * Major BLA amendment added two-year open-label extension (OLE) HOPE-3 data and proposed a refined indication focused on upper limb impairment in patients > 9 years old * Two-year HOPE-3 OLE data presented at the World Muscle Society (WMS) Congress: 76% slower upper limb decline after patients switched from placebo to Deramiocel * HOPE-3 cardiac results received the American Heart Association (AHA) Outstanding Research Award in Pediatric Cardiology * Cash, cash equivalents, restricted cash and marketable securities of approximately $199 million as of September 30, 2026 * Conference call and webcast today at 4:30 p.m. ET SAN DIEGO, Nov. 10, 2026 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced its financial results for the third quarter ended September 30, 2026, and provided a corporate update.
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