Capricor Therapeutics Inc Stock Price, News & Analysis

Capricor Therapeutics (CAPR) reported Q1 2025 financial results and provided updates on its lead candidate deramiocel. The company's BLA for deramiocel in treating Duchenne muscular dystrophy (DMD) remains under FDA priority review with a PDUFA date of August 31, 2025. A mid-cycle review meeting revealed no significant deficiencies, and an advisory committee meeting is planned. The company reported a cash position of $144.8M, expected to fund operations into 2027. Q1 financial results showed zero revenue compared to $4.9M in Q1 2024, with a net loss of $24.4M ($0.53 per share) versus $9.8M ($0.31 per share) in Q1 2024. Notable developments include appointing Dr. Michael Binks as CMO and NIAID's plans to initiate a Phase 1 trial of Capricor's StealthX™ exosome vaccine in Q3 2025.

Capricor Therapeutics (NASDAQ: CAPR) has appointed Dr. Michael Binks as Chief Medical Officer, effective immediately. Dr. Binks, a board-certified rheumatologist with 25 years of experience, joins Capricor ahead of the potential approval of deramiocel in Q3 2025. He previously served as Vice President and Head of Rare Disease Clinical and Translational Research at Pfizer, where he led global clinical efforts across multiple studies, including several in Duchenne muscular dystrophy (DMD). His expertise spans immunology, neurology, cardiology, nephrology, and hematology, with a track record of advancing first-in-class therapies including Benlysta, Hympavzi, Paxlovid, and Beqvez. The appointment strengthens Capricor's medical leadership as the company advances deramiocel toward potential commercialization for DMD treatment and explores pipeline expansion opportunities.

Capricor Therapeutics (NASDAQ: CAPR) has announced it will release its Q1 2025 financial results on Tuesday, May 13, 2025, after market close, followed by a conference call at 4:30 p.m. ET. The company, focused on developing cell and exosome-based therapeutics for rare diseases, is advancing its lead candidate deramiocel, an allogeneic cardiac-derived cell therapy. Deramiocel is in late-stage development for treating Duchenne muscular dystrophy (DMD), showing promising immunomodulatory and anti-fibrotic properties. Capricor has secured an exclusive commercialization agreement with Nippon Shinyaku for deramiocel in the US and Japan. The company is also developing its proprietary StealthX™ platform for various therapeutic applications including vaccinology and targeted delivery of therapeutics.

Capricor Therapeutics (NASDAQ: CAPR) has completed its mid-cycle review meeting with the FDA regarding deramiocel, a cell therapy treatment for Duchenne Muscular Dystrophy (DMD) cardiomyopathy. The FDA reported no significant deficiencies and confirmed the PDUFA target action date of August 31, 2025. An advisory committee meeting will be held before the target date. The BLA submission is supported by cardiac data from Phase 2 HOPE-2 and HOPE-2 Open Label Extension trials. Deramiocel, which has received Orphan Drug Designation from both FDA and EMA, consists of allogeneic cardiosphere-derived cells that help preserve cardiac and skeletal muscle function through immunomodulatory and anti-fibrotic actions. DMD affects approximately 15,000-20,000 patients in the United States, occurring in about one in 3,500 male births, with heart failure being the leading cause of death.

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.