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 that the FDA has extended the PDUFA target action date for its Biologics License Application for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD), from August 22, 2026 to November 22, 2026.
The extension follows Capricor’s BLA amendment submitting 24‑month open‑label extension data from the pivotal Phase 3 HOPE‑3 study and additional robustness analyses, supporting a refined proposed indication focused on upper limb function, the trial’s primary endpoint. The FDA’s CBER accepted the amendment as a major amendment and cited the significant unmet medical need in DMD as it continues reviewing the existing and new data.
According to Capricor, HOPE‑3 met its primary endpoint with a statistically significant benefit in upper limb function. Deramiocel holds Orphan Drug, RMAT and Rare Pediatric Disease designations in the U.S., which may qualify the company for a Priority Review Voucher if the therapy is approved.
Kaos Capital, a significant and growing shareholder of Capricor Therapeutics (NASDAQ: CAPR), has issued a detailed letter urging fellow shareholders to support an immediate meeting with Capricor’s board to discuss cash preservation, governance changes, strategic alternatives, and resolution of legal overhang.
According to Kaos Capital, Capricor held $237.9 million in cash, cash equivalents, and marketable securities at June 30, 2026, down about $80.2 million from year‑end 2025, and reported $79.7 million in first‑half 2026 operating expenses, including $23.5 million in G&A, approximately double the prior‑year period. Kaos Capital plans to nominate two independent directors, push for an independent M&A and Strategic Alternatives Committee, and press for a formal cash‑preservation plan and a structured process to address multiple ongoing legal matters. If the board does not engage on the requested timetable, Kaos Capital signals it may seek broader board and potential management changes.
Capricor Therapeutics (NASDAQ: CAPR) reported second quarter 2026 results and regulatory progress for its lead DMD cell therapy, Deramiocel. The Biologics License Application remains under active FDA review, following a July advisory committee vote of 3–9 against evidence of effectiveness for cardiomyopathy in DMD.
The Phase 3 HOPE-3 study, now published in The Lancet, met its primary endpoint by significantly slowing upper limb disease progression (PUL 2.0, p=0.029), with additional nominally significant functional and cardiac measures. Capricor has delivered ~1,300 Deramiocel infusions to over 200 patients, with more than 80 in long-term extension studies.
As of June 30, 2026, Capricor held approximately $237.9 million in cash, cash equivalents and marketable securities, down from $318.1 million at year-end 2025. Q2 2026 total operating expenses were $42.9 million versus $27.7 million a year earlier, resulting in a net loss of $40.7 million, or $0.70 per share. The company expects its current resources to fund operations for at least 12 months and is moderating commercial build-out and pipeline activities pending greater regulatory clarity for Deramiocel.
Capricor Therapeutics (NASDAQ: CAPR) will release its second quarter 2026 financial results for the period ended June 30, 2026, after market close on Thursday, August 13, 2026. Management will host a conference call and webcast at 4:30 p.m. ET the same day to discuss results and provide a recent corporate update.
The call can be accessed via toll-free and international dial-in numbers using Conference ID 91880, or through a webcast link. A replay will be available shortly after in the Investors section of Capricor’s website. Capricor’s lead candidate, Deramiocel, is in late-stage development for Duchenne muscular dystrophy, and the company is also advancing its StealthX™ exosome platform.
Capricor Therapeutics (NASDAQ: CAPR) reported that the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee voted that available evidence does not support the effectiveness of Deramiocel for treating cardiomyopathy in Duchenne muscular dystrophy (DMD), with a vote of 3 in favor and 9 against. The vote is non-binding and addressed a narrower cardiomyopathy indication than Capricor had proposed, and the Committee did not vote on Deramiocel’s overall benefit-risk profile.
According to Capricor, Advisory Committee discussion on upper limb function was directionally supportive of Phase 3 HOPE-3 data, including the primary endpoint PUL 2.0. Deramiocel has Orphan Drug designation in the U.S. and EU, RMAT and ATMP designations, and Rare Pediatric Disease designation, which may qualify Capricor for a Priority Review Voucher upon approval. Capricor continues to work with FDA ahead of the August 22, 2026 PDUFA target action date.
Capricor Therapeutics (NASDAQ: CAPR) reported that The Lancet has published pivotal Phase 3 HOPE-3 data for Deramiocel, its investigational cell therapy for Duchenne muscular dystrophy (DMD). The randomized, double-blind, placebo-controlled trial (n=106) met its primary endpoint, with Deramiocel slowing upper limb function decline by 54% versus placebo on the PUL 2.0 scale (p=0.03) and showing clinically meaningful cardiac benefits.
The Lancet publication followed independent expert peer review, providing external validation of the trial’s design, statistical methodology and findings used in the prespecified Statistical Analysis Plan 3.0. Deramiocel’s Biologics License Application is under active FDA review, with a PDUFA target action date of August 22, 2026, and the therapy holds multiple regulatory designations including Orphan Drug, RMAT, ATMP and Rare Pediatric Disease.
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.