Capricor Therapeutics Inc Stock Price, News & Analysis

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.

Capricor Therapeutics (NASDAQ: CAPR) announced it will present three-year safety and efficacy results from its HOPE-2 open-label extension (OLE) study for deramiocel, its lead asset for treating Duchenne muscular dystrophy (DMD). The data will be presented in a late-breaking poster at the 29th Annual Congress of the World Muscle Society (WMS 2024) in Prague, Czechia, from October 8-12, 2024.

The presentation, titled "Multi-modal benefits of deramiocel (CAP-1002) in late-stage patients with DMD: a new treatment approach to target skeletal and cardiac muscle pathogenesis (HOPE 2-OLE trial: 36-month data)," will be led by Dr. Craig McDonald from UC Davis. It will take place on October 11, 2024, from 9:45-10:45 a.m. EDT.

Linda Marbán, Ph.D., CEO of Capricor, stated that these results support the company's recent decision to begin filing a Biologics License Application (BLA) for potential approval of deramiocel to treat patients with DMD-cardiomyopathy.

Capricor Therapeutics (NASDAQ: CAPR) has announced its intent to file a Biologics License Application (BLA) for deramiocel, a potential treatment for Duchenne muscular dystrophy (DMD) cardiomyopathy. Key points include:

1. The BLA filing is planned to commence in October 2024, with full submission expected by year-end 2024.
2. The application will be based on existing cardiac data from Phase 2 HOPE-2 and HOPE-2 Open Label Extension trials, compared to natural history data.
3. The initial label would include all patients with cardiomyopathy associated with DMD.
4. Capricor plans to combine Cohorts A and B of the Phase 3 HOPE-3 clinical trial for potential label expansion to treat DMD skeletal muscle myopathy.
5. Deramiocel has received FDA Orphan Drug Designation and RMAT designation.

Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on developing cell and exosome-based therapeutics for rare diseases, has announced an upcoming investor webcast. The event, scheduled for Tuesday, September 24, 2024, at 8:30 a.m. ET, will provide an update on the company's Duchenne muscular dystrophy (DMD) program.

The webcast will include the latest regulatory updates following Capricor's recent meetings with the U.S. Food and Drug Administration (FDA). Investors can participate via conference call or webcast, with dial-in numbers provided for both domestic and international callers. A replay of the webcast will be available on the company's website after the live broadcast.

Capricor Therapeutics (NASDAQ: CAPR) has entered a binding term sheet with Nippon Shinyaku for the commercialization and distribution of deramiocel in Europe for treating Duchenne muscular dystrophy (DMD). The deal includes a $15 million equity investment at a 20% premium and a $20 million upfront payment upon signing the definitive agreement. Potential milestones could reach $715 million, with Capricor receiving a double-digit percentage of product revenue. This extends Capricor's cash runway into 2026 and brings the total potential milestones from combined distribution agreements to approximately $1.5 billion. Capricor will handle development and manufacturing, while Nippon Shinyaku will manage sales and distribution in Europe.

Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focusing on rare disease treatments, has announced its participation in several upcoming investor and scientific conferences. The company will present at the H.C. Wainwright 26th Annual Global Investment Conference on September 9, 2024, the 6th Annual Exosome-Based Therapeutic Summit from September 17-19, 2024, and the 2024 Cantor Fitzgerald's Global Healthcare Conference on September 18, 2024.

During these events, Capricor management will provide updates on the company's progress, particularly regarding its lead program, deramiocel for Duchenne muscular dystrophy (DMD) treatment. The presentations will include company overviews, one-on-one meetings, and participation in industry panels, offering investors and industry professionals insights into Capricor's latest developments in cell and exosome-based therapeutics.