Recent Insider Transactions Derivative • Jul 01
Executive VP exercised options and sold US$656k worth of stock On the 25th of June, Karen Krasney exercised 24k options at a strike price of around US$3.18 and sold these shares for an average price of US$30.38 per share. This trade did not impact their existing holding. Karen currently holds less than 1% of total shares outstanding. Company insiders have collectively sold US$7.3m more than they bought, via options and on-market transactions in the last 12 months. 속보 • Jun 27
FDA Advisory Committee Sets July 29 Review for Capricor’s Duchenne Therapy Deramiocel Capricor Therapeutics will go before an FDA advisory committee on 29 July 2026 to review its Biologics License Application for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy, supported by positive Phase 3 HOPE-3 data and five-year follow-up from the HOPE-2 extension study.
The advisory committee review and the FDA’s 22 August 2026 PDUFA target action date represent a potential inflection point for Deramiocel, given reported statistically significant efficacy outcomes, durable skeletal and cardiac muscle effects, and a favorable safety profile in long-term data.
Capricor’s stock last traded at US$26.44, with the share price down 13% over the past day.
The key question now is how closely the advisory committee and the FDA align with the clinical data package, since any divergence or additional data requests could materially affect Capricor’s regulatory timeline and funding needs. 공시 • Jun 26
Capricor Therapeutics Presents Positive Five-Year HOPE-2 Ole Data and HOPE-3 Phase 3 Results for Deramiocel in Duchenne Muscular Dystrophy Capricor Therapeutics announced positive five-year data from its ongoing HOPE-2 Open-Label Extension (OLE) study of Deramiocel, the Company’s lead cell therapy candidate for Duchenne Muscular Dystrophy (DMD). The data will be presented at the Parent Project Muscular Dystrophy (PPMD) 2026 Annual Conference, taking place June 25-27, 2026, in Orlando, Florida, alongside previously reported results from the Company’s HOPE-3 Phase 3 trial. Among the patients who remain enrolled in the HOPE-2 OLE study (n=9), treatment with Deramiocel continued to attenuate disease progression over five years, as measured by Performance of the Upper Limb (PUL 2.0). Patients experienced a mean total-score decline of less than 5 points over five years. By comparison, a cohort-matched external comparator of standard-of-care DMD patients showed a modeled decline of roughly 2.4 points per year, which if continued would project to approximately 12 points over five years. A separately published natural-history analysis (Coratti, et al., J Neuromuscular Dis, 2025) reported a decline in non-ambulant patients of approximately 8.1 points over three years, consistent with a meaningful treatment benefit. Cardiac function, as measured by left ventricular ejection fraction (LVEF) on cardiac MRI, remained stable over the full five-year period, in contrast to the modeled decline of approximately 3.2% per year observed in a propensity-matched external cardiac comparator. Deramiocel continued to demonstrate a favorable safety profile throughout the study, consistent with over 800 intravenous infusions administered to date across the Deramiocel clinical development program. The multicenter, randomized, double-blind, placebo-controlled trial enrolled 106 patients with DMD and met its primary endpoint (PUL 2.0, p=0.03) and key secondary cardiac endpoint (LVEF, p=0.04), along with all other Type I error-controlled secondary endpoints – consistent with the durable skeletal and cardiac muscle benefit observed in the HOPE-2 OLE study. Deramiocel (CAP-1002) consists of allogeneic cardiosphere-derived cells (CDCs), a rare population of cardiac cells that have been shown in preclinical and clinical studies to exert potent immunomodulatory and anti-fibrotic actions in the preservation of cardiac and skeletal muscle function in muscular dystrophies such as DMD. CDCs act by secreting extracellular vesicles known as exosomes, which target macrophages and alter their expression profile to adopt a healing rather than pro-inflammatory phenotype. CDCs have been investigated in more than 250 peer-reviewed scientific publications and administered to over 250 human subjects across multiple clinical trials. Deramiocel has received Orphan Drug Designation for the treatment of DMD from both the U.S. FDA and the European Medicines Agency (EMA). In addition, it has been granted Regenerative Medicine Advanced Therapy (RMAT) designation in the U.S., Advanced Therapy Medicinal Product (ATMP) designation in Europe, and Rare Pediatric Disease Designation from the FDA, which may qualify Capricor for a Priority Review Voucher upon approval. 속보 • Jun 13
Capricor Therapeutics Advances Toward FDA Decision on Duchenne Therapy With Market Launch in Sight Capricor Therapeutics is preparing for an FDA review of its lead cell therapy Deramiocel for Duchenne muscular dystrophy, with a PDUFA target date set for August 22, 2026.
The HOPE-3 trial met its primary and key secondary endpoints, with reported skeletal and cardiac benefits in treated patients.
The company has completed an FDA Pre-License Inspection at its San Diego GMP facility, plans to independently launch Deramiocel, and expects manufacturing expansion in the first half of 2027, with funding stated to extend operations through at least Q4 2027.
The combination of positive HOPE-3 data, a defined PDUFA date, and an inspected manufacturing facility places Capricor at a pivotal point, where regulatory, clinical and operational elements are aligning around a potential Deramiocel launch.
Investors may wish to monitor how the company executes on its independent commercialization plans, including pricing, market access and scaling capacity, as well as any updates around demand expectations and reimbursement for a high-touch cell therapy in a rare disease setting.