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Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for...
Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for Duchenne Muscular Dystrophy FDA issued Complete Response Letter Capricor plans to resubmit its BLA to include data from the ongoing Phase 3 HOPE-3 trial in Q3 2025 to continue pursuing the indication for the treatment of cardiomyopathy associated with Duchenne muscular dystrophyFDA advised Capricor to request a meeting to determine next steps toward potential approvalConference call and webcast scheduled for today at 8:30 a.m. ET SAN DIEGO, July 11, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company dev...
Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for...
Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for Duchenne Muscular Dystrophy FDA has indicated that an Advisory Committee meeting is not required at this timeIn-person late-cycle review meeting scheduled for mid-July Biologics License Application (BLA) remains under Priority Review with PDUFA target action date of August 31, 2025Four-year data presented at PPMD 2025 Conference demonstrate sustained cardiac function SAN DIEGO, June 24, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for r...
Capricor Therapeutics Announces Positive 4-Year Data from HOPE-2 Open-...
Capricor Therapeutics Announces Positive 4-Year Data from HOPE-2 Open-Label Extension Study of Deramiocel in Duchenne Muscular Dystrophy Four-year data show preservation of cardiac function, including LVEFSkeletal muscle disease progression continues to slow with extended treatment (PUL v2.0)Deramiocel’s long-term safety profile remains favorableResults presented at PPMD’s 2025 Annual Conference SAN DIEGO, June 20, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced positive fou...
Capricor Therapeutics Announces Orphan Drug Designation for Becker Mus...
Capricor Therapeutics Announces Orphan Drug Designation for Becker Muscular Dystrophy and Regulatory Progress for Duchenne Muscular Dystrophy Program U.S. FDA grants Orphan Drug Designation to Deramiocel for the treatment of Becker Muscular Dystrophy, broadening Capricor’s focus in neuromuscular diseasesCapricor remains on track for the August 31, 2025, PDUFA date for Deramiocel in Duchenne Muscular Dystrophy following successful FDA Pre-License Inspection SAN DIEGO, June 17, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-base...
Capricor Therapeutics Announces Key Regulatory Updates for its Duchenn...
Capricor Therapeutics Announces Key Regulatory Updates for its Duchenne Muscular Dystrophy Program U.S. FDA successfully completed Pre-License Inspection; Company expects facility will meet all requirements to support licensureAdvisory Committee meeting scheduled for July 30, 2025Mid-cycle meeting recently completed with no significant issues or major deficiencies; late-cycle meeting planned for mid-JulyBiologics License Application remains under priority review with PDUFA target action date of August 31, 2025 SAN DIEGO, June 11, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnolog...
Capricor Therapeutics Reports First Quarter 2025 Financial Results and...
Capricor Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update Biologics License Application (BLA) for deramiocel in the treatment of Duchenne muscular dystrophy (DMD) remains under priority review by the U.S. FDA, with a target Prescription Drug User Fee Act (PDUFA) date slated for August 31, 2025Recently completed mid-cycle review meeting with FDA with no significant deficiencies identified; late cycle meeting scheduled for June FDA has indicated intent to convene advisory committee meetingAppointed Dr. Michael Binks as Chief Medical Officer, bringing dee...
Capricor Therapeutics Appoints Michael Binks, M.D. as Chief Medical Of...
Capricor Therapeutics Appoints Michael Binks, M.D. as Chief Medical Officer — Dr. Binks joins Capricor in anticipation of potential approval of deramiocel in Q3 2025, bringing extensive experience in neuromuscular and rare diseases — SAN DIEGO, May 13, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced the appointment of Michael Binks, M.D., as Chief Medical Officer, effective immediately. Dr. Binks brings 25 years of experience leading global clinical development and translat...
Capricor Therapeutics to Present First Quarter 2025 Financial Results ...
Capricor Therapeutics to Present First Quarter 2025 Financial Results and Recent Corporate Update on May 13 Company to Host Conference Call, May 13, 2025 at 4:30 p.m. ET SAN DIEGO, May 06, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, will release its financial results for the first quarter ended March 31, 2025, after the market close on Tuesday, May 13, 2025. Management will then host a webcast and conference call at 4:30 p.m. ET on May 13. Title:Capricor Therapeutics ...
Capricor Therapeutics Announces Completion of Mid-Cycle Review Meeting...
Capricor Therapeutics Announces Completion of Mid-Cycle Review Meeting with FDA on Deramiocel for the Treatment of Duchenne Muscular Dystrophy Cardiomyopathy -Company remains on track for PDUFA target action date of August 31, 2025- -Advisory committee meeting to be held in advance of target action date- SAN DIEGO, May 05, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced the completion of a mid-cycle review meeting with the U.S. Food and Drug Admi...
Capricor Therapeutics to Present at the 2025 Piper Sandler Virtual Car...
Capricor Therapeutics to Present at the 2025 Piper Sandler Virtual Cardio Day SAN DIEGO, April 01, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced that the Company will present at the 2025 Piper Sandler Virtual Cardio Day taking place on April 2, 2025. Capricor will take part in a fireside chat to discuss the company’s latest advancements on its lead program of deramiocel for the treatment of Duchenne muscular dystrophy (DMD) as well as provide other general...
Capricor Therapeutics Reports Fourth Quarter and Full Year 2024 Financ...
Capricor Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update Announced the U.S. FDA has accepted our Biologics License Application (BLA) seeking full approval of deramiocel for the treatment of Duchenne muscular dystrophy (DMD) cardiomyopathyBLA granted priority review with a Prescription Drug User Fee Act (PDUFA) target action date set for August 31, 2025 Reported positive data from HOPE-2 open label extension (OLE) trial at 2025 MDA Conference showing preservation of skeletal muscle function over 3 years resulting in 52% slowing of diseas...
Capricor Therapeutics Announces Positive Data Demonstrating Long-Term ...
Capricor Therapeutics Announces Positive Data Demonstrating Long-Term Efficacy of Deramiocel for the Treatment of Duchenne Muscular Dystrophy --Preservation of Skeletal Muscle Function Shown Over 3 Years Resulting in 52% Slowing of Disease-- --Data Presented at the 2025 Muscular Dystrophy Association (MDA) Conference-- SAN DIEGO, March 17, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced positive long-term data from its ongoing HOPE-2 open la...
Capricor Therapeutics to Present Fourth Quarter and Full Year 2024 Fin...
Capricor Therapeutics to Present Fourth Quarter and Full Year 2024 Financial Results and Recent Corporate Update on March 19 Company to Host Conference Call, March 19, 2025 at 4:30 p.m. ET SAN DIEGO, March 11, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, will release its financial results for the fourth quarter and full year ended December 31, 2024, after the market close on Wednesday, March 19, 2025. Management will then host a webcast and conference call at 4:30 p.m. ...
- Jonathan Moreland
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Capricor Therapeutics to Present at Leerink’s Global Healthcare Confer...
Capricor Therapeutics to Present at Leerink’s Global Healthcare Conference 2025 SAN DIEGO, March 07, 2025 (GLOBE NEWSWIRE) -- (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, 2025Time: 1:00-1:40 p.m. ...
- Jonathan Moreland
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Capricor Therapeutics Announces FDA Acceptance and Priority Review of ...
Capricor Therapeutics Announces FDA Acceptance and Priority Review of its Biologics License Application for Deramiocel to Treat Duchenne Muscular Dystrophy --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) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare dise...
Capricor Therapeutics to Participate in Upcoming Investor Conferences
Capricor Therapeutics to Participate in Upcoming Investor Conferences SAN DIEGO, Feb. 10, 2025 (GLOBE NEWSWIRE) -- (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 Link Event:Barclays 27thAnnual Global Healthcare Conference (Miami, FL)Date:March 11-13, 2025 Event:3...
- Jonathan Moreland
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