Welcome to our dedicated page for Capricor Therapeutics news (Ticker: CAPR), a resource for investors and traders seeking the latest updates and insights on Capricor Therapeutics stock.
Capricor Therapeutics develops cell and exosome-based therapeutics for rare diseases, with Deramiocel, an allogeneic cardiac-derived cell therapy, as its lead program for Duchenne muscular dystrophy. Company news commonly covers HOPE-3 clinical data, Biologics License Application communications with the FDA, regulatory designations for Deramiocel, and manufacturing activities tied to the DMD program.
Updates also include financial results, corporate presentations at neurology and muscular dystrophy medical meetings, collaboration revenue references tied to its U.S. Distribution Agreement with Nippon Shinyaku, and preclinical work using the StealthX exosome platform for vaccinology and delivery of oligonucleotides, proteins, and small-molecule therapeutics.
Capricor Therapeutics (NASDAQ: CAPR) reported an update ahead of the July 29 FDA Advisory Committee meeting, where an independent panel will discuss Capricor’s Biologics License Application (BLA) for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD).
According to Capricor, its efficacy results are governed by the final statistical analysis plan (SAP) version 3.0, finalized before unblinding. The company stated that post-hoc analyses in FDA briefing materials use SAP version 1.1, described as an unsigned, incomplete internal draft that became obsolete after adding cohort B and omitted FDA-requested content. Capricor reports that the Phase 3 HOPE-3 trial showed a statistically significant benefit on the primary endpoint, PUL 2.0, with supportive cardiac function data, and believes Deramiocel may offer a meaningful option for boys and young men with DMD. Selected advisory committee slides are being posted in the Investors section of Capricor’s website.
Capricor Therapeutics (NASDAQ: CAPR) announced that the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee will review its BLA for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy, on July 29, 2026.
The BLA is supported by Phase 2 HOPE-2 and HOPE-2-OLE data and the Phase 3 HOPE-3 trial, which reached statistical significance on its primary PUL v2.0 endpoint, key cardiac endpoint LVEF, and other controlled secondary endpoints. The BLA remains on track with a PDUFA target date of August 22, 2026. Deramiocel has U.S. and EU Orphan Drug designations, U.S. RMAT and Rare Pediatric Disease designations, and EU ATMP status, which may qualify Capricor for a Priority Review Voucher upon approval.
Capricor Therapeutics (NASDAQ: CAPR) reported five-year HOPE-2 OLE data and HOPE-3 Phase 3 results for Deramiocel in Duchenne muscular dystrophy at the PPMD 2026 conference.
Deramiocel reduced PUL 2.0 decline to under 5 points over five years, preserved LVEF, met primary and key secondary endpoints, showed no new safety signals, and is under FDA BLA review with an August 22, 2026 PDUFA date.
Capricor Therapeutics (NASDAQ: CAPR) announced participation in two investor events in Miami on Wednesday, June 10: the Goldman Sachs 47th Annual Global Healthcare Conference, featuring a fireside chat and investor meetings at 10:00 a.m. ET, and the Oppenheimer CNS and Neuro-Muscular Summit.
A live webcast and replay of the Goldman Sachs session will be accessible via the Investors section of Capricor’s website. The company is developing Deramiocel for Duchenne muscular dystrophy and advancing its StealthX exosome platform.
Capricor Therapeutics (NASDAQ: CAPR) will release first quarter 2026 financial results after market close on May 12, 2026 and will host a conference call and webcast the same day at 4:30 p.m. ET. A replay will be available in the Investors section of capricor.com.
The company described its lead candidate Deramiocel (late-stage development for Duchenne muscular dystrophy) and its StealthX exosome platform in preclinical work.
Capricor Therapeutics (NASDAQ: CAPR) presented Phase 3 HOPE-3 results for Deramiocel in Duchenne muscular dystrophy at AAN 2026, reporting a statistically and clinically meaningful benefit on the upper-limb primary endpoint (PUL v2.0) and supportive Duchenne Video Assessment (DVA) findings.
The company has a BLA under FDA review with a PDUFA target action date of August 22, 2026 and an exclusive U.S./Japan commercialization agreement with Nippon Shinyaku.
Capricor Therapeutics (NASDAQ: CAPR) reported Q4 and full-year 2025 results and a corporate update. Key items: Deramiocel BLA is under FDA review with a PDUFA target action date of August 22, 2026. Phase 3 HOPE-3 met primary (PUL v2.0, p=0.03) and key cardiac (LVEF, p=0.04) endpoints. Cash and marketable securities were approximately $318.1 million as of December 31, 2025, supporting operations through 2027. San Diego GMP facility is operational and the company uplisted to the Nasdaq Global Select Market.
Capricor Therapeutics (NASDAQ: CAPR) reported additional Phase 3 HOPE-3 results presented at the 2026 MDA conference showing statistically significant functional and cardiac benefits of Deramiocel in Duchenne muscular dystrophy.
Key findings: reduced myocardial fibrosis by three segments (LGE, p=0.022), LVEF +3.3 percentage points in baseline cardiomyopathy subgroup (p=0.017), GST composite benefit (p=0.017), and ~83% slowing on the Duchenne Video Assessment eat-10 task (p=0.018). A Biologics License Application is under FDA review with a PDUFA date of August 22, 2026.
Capricor Therapeutics (NASDAQ: CAPR) announced the FDA has lifted its Complete Response Letter and resumed review of the Deramiocel BLA as a Class 2 resubmission, setting a PDUFA target action date of August 22, 2026. The company expects potential eligibility for a Priority Review Voucher upon approval.
Deramiocel is supported by positive HOPE-3 Phase 3 results and holds multiple designations including Orphan Drug, RMAT, ATMP, and Rare Pediatric Disease.
Capricor Therapeutics (NASDAQ: CAPR) will release fourth quarter and full year 2025 financial results after market close on March 12, 2026 and will host a conference call and webcast at 4:30 p.m. ET.
Replay will be available in the Investors section at capricor.com. Capricor highlighted lead candidate Deramiocel in late-stage development for Duchenne muscular dystrophy and its StealthX exosome platform. The company has an exclusive U.S. and Japan commercialization agreement with Nippon Shinyaku, subject to regulatory approval.