Core Viewpoint - Capricor Therapeutics has initiated a rolling submission process for a Biologics License Application (BLA) for deramiocel, aimed at treating Duchenne muscular dystrophy (DMD) cardiomyopathy, with plans to complete the submission by the end of 2024 and potential eligibility for priority review by the FDA [1][2]. Group 1: Company Overview - Capricor Therapeutics is a biotechnology company focused on developing cell and exosome-based therapeutics for rare diseases, with deramiocel (CAP-1002) as its lead product candidate [6]. - The company has entered into an exclusive commercialization agreement for deramiocel in the U.S. and Japan with Nippon Shinyaku Co., Ltd., pending regulatory approval [9]. Group 2: Product Details - Deramiocel consists of allogeneic cardiosphere-derived cells (CDCs) that have shown immunomodulatory, antifibrotic, and regenerative effects in preclinical and clinical studies [3]. - The product has received Orphan Drug Designation and is supported by the Regenerative Medicine Advanced Therapy (RMAT) designation [4]. Group 3: Disease Context - Duchenne muscular dystrophy (DMD) is a severe genetic disorder affecting approximately 15,000-20,000 individuals in the U.S., characterized by progressive muscle weakness and inflammation, with a median mortality age of around 30 years [5]. - There are currently no approved treatment options for DMD cardiomyopathy, highlighting the significance of deramiocel as a potential first-in-class therapy [2][5].

Capricor Therapeutics (CAPR) closed the last trading session at $18.09, gaining 330.7% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $34.40 indicates a 90.2% upside potential. The average comprises five short-term price targets ranging from a low of $25 to a high of $43, with a standard deviation of $8.71. While the lowest estimate indicates an increase of 38.2% from the current ...

Capricor Therapeutics Inc. CAPR is a biotechnology firm focused on developing cell and exosome-based treatments for rare diseases like Duchenne muscular dystrophy (DMD). Capricor's stock surged more than 100% after announcing it will pursue full FDA approval for its primary drug deramiocel (CAP-1002) in this year. The medical sector company plans to file the biologics license application (BLA) in October 2024, seeking full FDA approval to treat all patients with cardiomyopathy associated with DMD. This rare ...

Capricor Therapeutics Inc. NASDAQ: CAPR is a biotechnology firm focused on developing cell and exosome-based treatments for rare diseases like Duchenne muscular dystrophy (DMD). Capricor's stock surged more than 100% after announcing it will pursue full FDA approval for its primary drug deramiocel (CAP-1002) in this year. The medical sector company plans to file the biologics license application (BLA) in October 2024, seeking full FDA approval to treat all patients with cardiomyopathy associated with DMD. C ...

Core Viewpoint - Capricor Therapeutics, Inc. plans to file a Biologics License Application (BLA) for deramiocel aimed at treating patients with Duchenne Muscular Dystrophy (DMD) cardiomyopathy [2] Company Summary - Capricor Therapeutics is advancing its product deramiocel for DMD cardiomyopathy, indicating progress in its clinical development [2]

Capricor Therapeutics (CAPR) shares rallied 18.2% in the last trading session to close at $5.97. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 10.8% gain over the past four weeks. The sharp upsurge in Capricor's shares can be attributed to the company's anticipated regulatory update on deramiocel for Duchenne muscular dystrophy (DMD) in an investor webcast scheduled for Sept. 24. The webcast will include th ...

SAN DIEGO, Sept. 23, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced that it will host an investor webcast on Tuesday, September 24, 2024 at 8:30 a.m. ET to provide an update on its Duchenne muscular dystrophy (DMD) program. The update will consist of the latest regulatory updates following the Company's recent meetings with the U.S. Food and Drug Administr ...

-Capricor to Receive $15 Million Equity Investment at a 20% Premium, as well as $20 Million Upfront Payment upon Signing Definitive Agreement with up to $715 Million in Potential Milestones and a DoubleDigit Percentage of Product Revenue- -Upfront Payment and Investment Extends Cash Runway into 2026- -Potential Milestones from Combined Distribution Agreements Now Total approximately $1.5 Billion- -Capricor Preparing to Meet with EMA to Discuss European Expansion for Deramiocel- SAN DIEGO, Sept. 17, 2024 (GL ...

Core Insights - Capricor Therapeutics is focused on developing cell and exosome-based therapeutics for rare diseases, with a lead program for deramiocel aimed at treating Duchenne muscular dystrophy (DMD) [1][3] - The company will present updates on its progress and scientific developments at various upcoming investor and scientific conferences [2] Company Overview - Capricor Therapeutics, Inc. (NASDAQ: CAPR) is dedicated to advancing innovative therapies for rare diseases, with deramiocel (CAP-1002) being a key product candidate currently in Phase 3 clinical development for DMD [3] - Deramiocel is an allogeneic cardiac-derived cell therapy that has shown immunomodulatory, antifibrotic, and regenerative properties in preclinical and clinical studies [3] - The company is also developing its proprietary StealthX™ platform for exosome technology, targeting applications in vaccinology and the delivery of therapeutics [3] Commercial Agreements - Capricor has entered into an exclusive agreement with Nippon Shinyaku Co., Ltd. for the commercialization and distribution of deramiocel in the United States and Japan, pending regulatory approval [5]

Capricor Therapeutics, Inc. (NASDAQ:CAPR) Q2 2024 Earnings Conference Call August 7, 2024 4:30 PM ET Company Participants Linda Marban – Chief Executive Officer AJ Bergmann – Chief Financial Officer Conference Call Participants Joseph Pantginis – H.C. Wainwright Leland Gershell – Oppenheimer Aydin Huseynov – Ladenburg Rick Miller – Cantor Operator Good afternoon, ladies and gentlemen, and welcome to the Capricor Therapeutics Second Quarter 2024 Earnings Call. At this time, all participant lines are in a lis ...