SAN DIEGO, March 07, 2025 (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 Capricor management will participate in one-on-one investor meetings and provide a corporate update at Leerink’s Global Healthcare Conference 2025, taking place March 10-12, 2025 in Miami, Florida. Leerink’s Global Healthcare Conference 2025 Presentation Date: Wednesday, March 12, 202 ...

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Core Points - The FDA has accepted Capricor Therapeutics Inc's Biologics License Application for deramiocel, aimed at treating Duchenne muscular dystrophy (DMD) cardiomyopathy [1] - The FDA granted Priority Review status with a target action date of August 31, 2025 [1] - No potential review issues have been identified by the FDA [2] Company and Industry Summary - The BLA submission is supported by data from Capricor's Phase 2 HOPE-2 and HOPE-2 Open Label Extension trials, which were compared to natural history data [3] - The FDA has not yet determined if an Advisory Committee meeting will be necessary for this application [3] - Deramiocel has received Orphan Drug Designation from both the FDA and the European Medicines Agency [4] - If approved by September 30, 2026, Capricor could receive a Priority Review Voucher due to its previous rare pediatric disease designation [4] - CAPR stock increased by 6.33% to $14.54 following the news [4]

--FDA assigns PDUFA target action date of August 31, 2025-- --If approved, deramiocel would be first therapy to treat Duchenne muscular dystrophy cardiomyopathy-- --At this time, FDA has not identified any potential review issues with the BLA-- SAN DIEGO, March 04, 2025 (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 U.S. Food and Drug Administration (“FDA”) ...

…deramiocel was slowing the trajectory of cardiac dysfunction in DMD measuredCapricor Therapeutics (NASDAQ: CAPR ) recently submitted its BLA for lead candidate deramiocel for patients with Duchenne muscular dystrophy (DMD) cardiomyopathy. As the company noted in their earnings call:About the TPT serviceThanks for reading. At the Total Pharma Tracker, we offer the following:-Our Android app and website features a set of tools for DIY investors, including a work-in-progress software where you can enter any t ...

SAN DIEGO, Feb. 10, 2025 (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 scheduled to participate in the following upcoming investor conferences. Event:Oppenheimer 35thAnnual Healthcare Life Sciences Conference (Virtual)Date:February 12, 2025 from 12:00-12:30 p.m. ETWebcast LinkClick here Event:Barclays 27thAnnual Global Healthcare Conferenc ...

Capricor Therapeutics (CAPR) closed the last trading session at $13.47, gaining 7.6% 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 $41.50 indicates a 208.1% upside potential.The mean estimate comprises six short-term price targets with a standard deviation of $18.52. While the lowest estimate of $25 indicates an 85.6% increase from the current price level, the most optimistic ana ...

Shares of Capricor Therapeutics (CAPR) gained 8.4% on Thursday following the completion of the submission of a biologics license application (BLA) to the FDA seeking full approval for deramiocel to treat patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy. CAPR’s lead product candidate and only clinical pipeline asset, deramiocel, is an investigational, allogeneic cardiac-derived cell therapy. A final decision of the FDA is anticipated in the second half of 2024.Capricor initiated its r ...

-If approved, deramiocel would be first approved therapy for Duchenne muscular dystrophy cardiomyopathy- -BLA submission triggers $10 million milestone payment to Capricor from Nippon Shinyaku- SAN DIEGO, Jan. 02, 2025 (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 completion of the submission of its Biologics License Application (BLA) to the U.S. Food and ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended September 30, 2024 or ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition period from to Commission File Number: 001-34058 CAPRICOR THERAPEUTICS, INC. (Exact Name Of Registrant As Specified In Its Charter) Delaware 88-0363465 (State ...