SAN DIEGO, July 01, 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 the Company is set to join the Russell 2000® Index and the broad-market Russell 3000® Index, effective at the open of U.S. equity markets today, July 1, 2024. "We are thrilled to be joining the Russell 2000® Index, a testament to our Company's progress across our pipeline marked by sign ...

-Results in Performance of the Upper Limb (PUL v2.0) Continue to Show Slowing of Disease Progression in Later-Stage DMD Patients- -Pre-BLA Meeting with FDA Scheduled for Q3 2024 to Discuss Options to Expedite BLA Filing- SAN DIEGO, June 28, 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 additional positive 3-year safety and efficacy results from its ongoing ...

About Capricor Therapeutics Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapeutics to redefine the treatment landscape for rare diseases. At the forefront of our innovation is our lead product candidate, deramiocel (CAP-1002), an allogeneic cardiac-derived cell therapy. Extensive preclinical and clinical studies have shown deramiocel to demonstrate immunomodulatory, antifibrotic, and regenerative actions specifically ta ...

SAN DIEGO, June 25, 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 the U.S. Food and Drug Administration (FDA) has scheduled a Pre-BLA (Biologics License Application) meeting with the Company in the third quarter of 2024 for deramiocel (CAP1002), for the treatment of Duchenne Muscular Dystrophy (DMD). Capricor's goal for this meeting will be to finali ...

About Capricor Therapeutics Capricor Therapeutics, Inc. (NASDAQ:CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapeutics to redefine the treatment landscape for rare diseases. At the forefront of our innovation is our lead product candidate, deramiocel (CAP-1002), an allogeneic cardiac-derived cell therapy. Extensive preclinical and clinical studies have shown deramiocel to demonstrate immunomodulatory, antifibrotic, and regenerative actions specifically tai ...

SAN DIEGO, June 11, 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 the successful completion of a Type-B meeting with the U.S. Food and Drug Administration (FDA) on next steps for the Biologics License Application (BLA) submission with its lead asset, CAP-1002 for the treatment of Duchenne muscular dystrophy (DMD). Additionally, Deramiocel has been selecte ...

SAN DIEGO, June 11, 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 the successful completion of a Type-B meeting with the U.S. Food and Drug Administration (FDA) on next steps for the Biologics License Application (BLA) submission with its lead asset, CAP-1002 for the treatment of Duchenne muscular dystrophy (DMD). Additionally, Deramiocel has been selecte ...

Capricor Therapeutics (CAPR) , a biotechnology firm focused on innovative therapies for rare diseases, has announced favorable three-year results from the ongoing HOPE-2 open-label extension (OLE) study on CAP1002 for Duchenne muscular dystrophy (DMD). Patients treated with CAP-1002 showed sustained improvements in upper limb function and cardiac performance compared to an external dataset from Cincinnati Children's Hospital Medical Center, indicating potential long-term benefits. Statistical Significance i ...

--Results in Performance of the Upper Limb (PUL 2.0) Continue to Show Benefits in Skeletal Muscle Function After 3 Years of CAP-1002 Treatment (p< 0.001)-- --Stabilization in Left Ventricular Ejection Fraction (LVEF) Suggests Preservation of Cardiac Function-- --Results Recently Shared with FDA at Type-B Meeting Held in May 2024-- SAN DIEGO, June 04, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ:CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the tre ...

Financial Position - As of March 31, 2024, Capricor Therapeutics had cash, cash equivalents, and marketable securities totaling approximately $39.9 million[396]. - The investment portfolio as of March 31, 2024, consisted primarily of money market funds and short-term U.S. treasuries[87]. - Capricor's current cash balance is expected to fund operating expenses and capital expenditures into Q1 2025, excluding potential milestone payments[396]. Revenue Generation - Capricor has not generated any revenues from the commercial sale of products and will not be able to do so until FDA approval is obtained[396]. Research and Development - R&D expenses are expected to increase due to additional non-cash compensation expenses in the future[401]. - There was a $0.5 million increase in stock-based compensation expense primarily due to an increase in the risk-free rate and stock price[405]. - The company is collaborating with an undisclosed pharmaceutical company to investigate the therapeutic application of its StealthX™ exosome platform[399]. - Data presented at the ASGCT 27th Annual Meeting highlighted a potential exosome-based approach for treating arginase-1 deficiency[399]. Milestones and Analysis - In Q4 2023, a positive outcome of the interim futility analysis for the HOPE-3 trial was announced, leading to a milestone payment of $10.0 million received in January 2024[396]. Internal Controls - There has been no change in internal control over financial reporting that materially affected the company during the quarter ended March 31, 2024[89].