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.
OmniAb (NASDAQ: OABI) has announced two strategic appointments to its Board of Directors: Philip J. Gotwals, Ph.D., and Steve Crouse, while Director Sarah Boyce steps down after nearly six years of service. These changes increase the board size to seven members.
Dr. Gotwals brings 30 years of biopharmaceutical experience, notably as Global Head of Business Development and Licensing at Novartis Institutes for BioMedical Research, where his team executed over 50 major strategic transactions. He will serve on the Human Capital Management & Compensation Committee and Science & Technology Committee.
Steve Crouse, currently Senior Vice President and General Manager of Bio-Techne's Analytical Solutions Division, contributes over 20 years of life sciences expertise. He will serve on the Audit Committee and Science & Technology Committee.
Capricor Therapeutics (NASDAQ: CAPR) announced its participation in the 2025 Piper Sandler Virtual Cardio Day on April 2, 2025. CEO Linda Marbán will lead a fireside chat from 12:00-12:30 p.m. ET to discuss updates on deramiocel, their lead program for treating Duchenne muscular dystrophy (DMD).
Deramiocel, an allogeneic cardiac-derived cell therapy, has demonstrated immunomodulatory and anti-fibrotic properties in preserving cardiac and skeletal muscle function in dystrophiopathies. The company is also developing its proprietary StealthX™ platform for exosome technology applications in vaccinology and targeted therapeutic delivery.
Capricor has secured an exclusive commercialization and distribution agreement with Nippon Shinyaku Co., for deramiocel in the United States and Japan, pending regulatory approval.
Capricor Therapeutics (CAPR) announced significant developments in Q4 2024 and FY2024. The FDA has accepted their Biologics License Application (BLA) for deramiocel, granting priority review with a PDUFA date of August 31, 2025. The therapy targets Duchenne muscular dystrophy (DMD) cardiomyopathy.
Key financial highlights include:
- Cash position of $151.5M as of December 31, 2024
- Q4 2024 revenues of $11.1M (vs $12.1M in Q4 2023)
- FY2024 revenues of $22.3M (vs $25.2M in 2023)
- Net loss of $7.1M in Q4 2024 ($0.16 per share)
- Current cash expected to support operations into 2027
Clinical data from the HOPE-2 open label extension trial showed a 52% slowing of disease progression over 3 years. The company received a $10M milestone payment from Nippon Shinyaku and expanded its manufacturing capacity in San Diego.
Capricor Therapeutics (NASDAQ: CAPR) announced positive long-term data from its HOPE-2 open label extension trial for deramiocel, showing significant efficacy in treating Duchenne muscular dystrophy (DMD). The data, presented at the 2025 MDA Conference, demonstrated a 52% slowdown in disease progression over three years.
Key findings show patients treated with deramiocel experienced an average decline of 3.46 points in Performance of the Upper Limb (PUL 2.0) total score, compared to 7.19 points in the control group (p=0.019). The treatment effect improved yearly, with mean annual PUL 2.0 declines of 1.8, 1.2, and 1.1 points in Years 1, 2, and 3 respectively.
The drug maintained a favorable safety profile with no new safety signals. The FDA has accepted Capricor's Biologics License Application for DMD-associated cardiomyopathy, with a PDUFA date set for August 31, 2025.
Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on developing cell and exosome-based therapeutics for rare diseases, has scheduled its fourth quarter and full year 2024 financial results announcement for March 19, 2025, after market close.
The company will host a conference call and webcast at 4:30 p.m. ET on the same day to discuss the results. A replay of the webcast will be made available on the company's website following the live broadcast.
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.