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 company dedicated to the discovery, development, and commercialization of pioneering biological therapeutics for the treatment of rare disorders. With a significant focus on novel treatment methodologies, Capricor leverages an extensive body of scientific research to innovate in the biotech sector.
The company's lead candidate, CAP-1002, is an “off-the-shelf” cardiac cell therapy designed for the treatment of Duchenne Muscular Dystrophy (DMD). CAP-1002 is composed of allogeneic cardiosphere-derived cells (CDCs), a unique cell population known for its potent immunomodulatory properties. These properties help in altering the immune system's activity to stimulate cellular regeneration. The efficacy and safety of CDCs are well-documented, with over 100 peer-reviewed scientific publications and administration to around 140 human subjects across several clinical trials.
Capricor's development pipeline also includes CDC-Exosomes (CAP-2003) and an Exosome-mRNA vaccine. These innovative platforms underline the company's commitment to expanding its therapeutic reach beyond DMD, addressing multiple medical conditions.
The company has recently shared positive updates, such as the 24-month results from the HOPE-2 Open Label Extension Study of CAP-1002 for DMD, highlighting sustained benefits and safety. Additionally, Capricor has ongoing programs addressing the COVID-19 pandemic and exploring new frontiers in exosome-based therapies.
Financially, Capricor continues to achieve crucial milestones, effectively managing its resources to advance its clinical programs. Recent operational highlights include strategic corporate updates and anticipated milestones for the CAP-1002 Duchenne Muscular Dystrophy Program and Exosome Program. The company actively engages with the scientific community through presentations and conference calls, emphasizing transparency and keeping stakeholders informed.
Capricor’s partnerships and collaborations further strengthen its research and development efforts, paving the way for groundbreaking advancements in treating rare and debilitating diseases. The company remains a significant player in the biotechnology sector, committed to transforming innovative research into tangible, life-changing therapies.
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.
Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on rare disease treatments, has announced a proposed underwritten public offering of common stock shares. The company plans to grant underwriters a 30-day option to purchase additional shares equal to 15% of those sold in the offering. Piper Sandler and Oppenheimer & Co. are acting as joint book-running managers. Capricor intends 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 and will be conducted via a prospectus and related supplement. The final terms are subject to market conditions, with no assurance of completion.
Capricor Therapeutics (NASDAQ: CAPR) announced positive 3-year safety and efficacy results from its ongoing HOPE-2 open label extension (OLE) study for deramiocel, its lead asset for treating Duchenne muscular dystrophy (DMD). The data, presented at the 29th Annual Congress of the World Muscle Society, showed sustained cardiac and skeletal muscle benefits after 3 years of continuous treatment.
Key findings include:
- Improvements in multiple cardiac measures, including left ventricular ejection fraction (LVEF%) and indexed volumes
- Statistically and clinically relevant benefit in PUL v2.0 total score compared to external comparator dataset
- Favorable safety profile for long-term treatment
Capricor is on track to fully submit a Biologics License Application (BLA) to the FDA by the end of 2024 for approval of deramiocel to treat DMD cardiomyopathy.
Capricor Therapeutics (NASDAQ: CAPR) has initiated a rolling submission process with the FDA for a Biologics License Application (BLA) seeking full approval of deramiocel to treat all patients with Duchenne muscular dystrophy (DMD) cardiomyopathy. The company plans to complete the rolling BLA submission by the end of 2024. The application may be eligible for priority review due to deramiocel's potential to significantly improve treatment for DMD cardiomyopathy, a serious condition with no currently approved treatment options. CEO Linda Marbán stated that this marks an important step in the U.S. regulatory process and could expedite the delivery of this novel, first-in-class treatment to patients in need.
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