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 Inc (NASDAQ: CAPR) is a clinical-stage biotechnology leader advancing novel cell and exosome-based therapies for rare diseases. This dedicated news hub provides investors and researchers with essential updates on therapeutic developments, regulatory milestones, and scientific advancements.
Discover comprehensive coverage of CAP-1002 clinical progress for Duchenne muscular dystrophy, StealthXTM platform innovations, and strategic partnerships driving next-generation treatments. Our curated repository ensures access to verified press releases and objective reporting on critical developments in cardiac cell therapies and exosome delivery systems.
Key updates include clinical trial phases, peer-reviewed research publications, manufacturing advancements, and regulatory interactions. Bookmark this page for real-time tracking of Capricor's progress in redefining regenerative medicine through rigorous scientific validation and targeted therapeutic approaches.
Capricor Therapeutics (NASDAQ: CAPR) has received FDA acceptance for its Biologics License Application (BLA) for deramiocel, an investigational cell therapy targeting Duchenne muscular dystrophy (DMD) cardiomyopathy. The FDA has granted Priority Review with a PDUFA target action date of August 31, 2025.
NS Pharma, a subsidiary of Nippon Shinyaku, will be exclusively responsible for the U.S. commercialization and distribution of deramiocel, following their exclusive distribution agreement established in January 2022. The FDA has not identified any potential review issues at this time.
Capricor Therapeutics (NASDAQ: CAPR), a biotech company focused on developing cell and exosome-based therapeutics for rare diseases, has announced its participation in Leerink's Global Healthcare Conference 2025. The conference will take place from March 10-12, 2025, in Miami, Florida.
The company's management will engage in one-on-one investor meetings and deliver a corporate presentation on Wednesday, March 12, 2025, from 1:00-1:40 p.m. ET. During the presentation, Capricor will provide updates on their lead program deramiocel, which targets the treatment of Duchenne muscular dystrophy (DMD), along with other scientific and corporate developments.
Capricor Therapeutics (NASDAQ: CAPR) announced FDA acceptance and Priority Review of its Biologics License Application (BLA) for deramiocel, a cell therapy treatment for Duchenne muscular dystrophy (DMD) cardiomyopathy. The FDA set a PDUFA target action date of August 31, 2025.
If approved, deramiocel would be the first therapy specifically targeting DMD cardiomyopathy. The treatment would be administered quarterly as a lifelong therapy. The BLA submission is supported by data from Phase 2 HOPE-2 and HOPE-2 Open Label Extension trials, compared with FDA-funded natural history data.
The FDA has not identified any potential review issues and has not yet decided on the need for an Advisory Committee meeting. Deramiocel has received Orphan Drug Designation from both FDA and EMA, along with RMAT designation in the U.S. and ATMP Designation in Europe.
Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on developing cell and exosome-based therapeutics for rare diseases, has announced its participation in three major upcoming investor conferences. The company will be presenting at:
• The Oppenheimer 35th Annual Healthcare Life Sciences Conference (Virtual) on February 12, 2025, from 12:00-12:30 p.m. ET
• The Barclays 27th Annual Global Healthcare Conference in Miami, FL (March 11-13, 2025)
• The 37th Annual ROTH Conference in Dana Point, CA (March 16-18, 2025)
During these conferences, Capricor's management will provide updates on their lead program, deramiocel, for treating Duchenne muscular dystrophy (DMD), along with general scientific and corporate updates.
Capricor Therapeutics (NASDAQ: CAPR) has completed its Biologics License Application (BLA) submission to the FDA for deramiocel, seeking full approval for treating Duchenne muscular dystrophy (DMD) cardiomyopathy. The submission triggers a $10 million milestone payment from Nippon Shinyaku.
The BLA is supported by cardiac data from Phase 2 HOPE-2 and HOPE-2 Open Label Extension trials, compared with FDA-funded natural history data. Capricor has requested priority review, which could reduce the review timeline from 10 to 6 months.
Deramiocel has received Orphan Drug Designation from both FDA and EMA, RMAT Designation in the U.S., and ATMP Designation in Europe. If approved, it would be the first therapy for DMD cardiomyopathy, and Capricor would be eligible for a Priority Review Voucher based on its rare pediatric disease designation.
Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on rare disease treatments through cell and exosome-based therapeutics, has announced its participation in two upcoming investor conferences. The company will present at the Piper Sandler 36th Annual Healthcare Conference on December 3, 2024, from 11:30-11:55 a.m. ET, featuring a fireside chat, industry panel, and one-on-one meetings. Additionally, Capricor will participate in the Oppenheimer Movers in Rare Disease Summit on December 12, 2024, from 10:00-10:50 a.m. ET. The Piper Sandler presentation will be available via webcast on Capricor's website.
Capricor Therapeutics (NASDAQ: CAPR) has received both Orphan Drug and Advanced Therapy Medicinal Product (ATMP) designations from the European Medicines Agency for deramiocel, its lead asset targeting Duchenne muscular dystrophy (DMD). The Orphan Drug status grants 10-year market exclusivity upon approval and reduced regulatory fees, while ATMP designation provides regulatory support for cell-based therapy development. The company has also initiated a rolling Biologics License Application with the FDA, expecting completion by end of 2024, seeking full approval for deramiocel in treating DMD-cardiomyopathy.
Capricor Therapeutics initiated a rolling BLA submission for deramiocel to treat DMD-cardiomyopathy, with full submission expected by year-end 2024. The company signed a binding term sheet with Nippon Shinyaku for European commercialization, potentially worth up to $715 million in milestones plus a $20 million upfront payment. Q3 2024 financial results showed revenues of $2.3 million and a net loss of $12.6 million. The company completed an $86 million public offering and expects cash runway into 2027. Positive 3-year data from HOPE-2 OLE trial demonstrated improvements in cardiac function and PUL v2.0 scores.
Capricor Therapeutics (NASDAQ: CAPR) announced the presentation of new preclinical data on their StealthX™ exosome platform at the 2024 American Association of Extracellular Vesicles Annual Meeting in Houston. The research showcases an innovative exosome-based approach for treating Duchenne muscular dystrophy (DMD) through the delivery of phosphorodiamidate morpholino oligomers (PMOs).
The study demonstrates improved cellular uptake and enhanced exon skipping efficiency using exosome-based therapeutics. CEO Linda Marbán highlighted the platform's potential as a delivery vehicle for various payloads and expressed interest in pursuing partnership opportunities to advance the technology.
Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on rare disease treatments through cell and exosome-based therapeutics, has scheduled its Q3 2024 financial results release and corporate update for November 13, 2024. The company will host a conference call and webcast at 4:30 p.m. ET following the market close. Investors can access the call via toll-free numbers or through a webcast link, with a replay available on the company's website after the event.
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