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) 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.
Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on rare disease treatments, has closed its underwritten public offering of 5,073,800 common stock shares. This includes the full exercise of the underwriters' over-allotment option. The offering generated gross proceeds of approximately $86.3 million before deducting underwriting commissions and other expenses. Piper Sandler & Co. and Oppenheimer & Co. Inc. served as joint book-running managers for the offering, which closed on October 18, 2024.
The company plans to use the net proceeds for continued product candidate development, manufacturing, working capital, and general corporate purposes. The securities were offered under an effective shelf registration statement, with a final prospectus supplement filed on October 17, 2024.
Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on rare disease treatments, has announced the pricing of its public offering. The company is offering 4,412,000 shares of common stock at $17.00 per share, with an option for underwriters to purchase an additional 661,800 shares. The offering, expected to close on October 18, 2024, aims to raise approximately $75 million in gross proceeds.
Piper Sandler & Co. and Oppenheimer & Co. Inc. are acting as joint book-running managers. Capricor plans to use the net proceeds for product candidate development, manufacturing, working capital, and general corporate purposes. The offering is made pursuant to an effective shelf registration statement filed with the SEC.