Capricor Therapeutics, Inc. Stock News

I am downgrading Capricor Therapeutics, Inc. stock from Strong Buy to Hold due to FDA Form 483 risks from a Pre-License Inspection of its manufacturing facility. While deramiocel's clinical data for DMD Cardiomyopathy is strong, the unresolved FDA inspection findings create significant regulatory uncertainty for CAPR. The timing of the FDA Advisory Committee meeting and PDUFA date introduces ad...

SAN DIEGO, June 11, 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 successful completion of the U.S. Food and Drug Administration's (FDA) Pre-License Inspection (PLI) of its San Diego manufacturing facility for Deramiocel, the Company's le...

Capricor Therapeutics basically has two platforms: Deramiocel CDC therapy and the StealthX exosome platform. However, its flagship candidate is undoubtedly Deramiocel, which has so far secured a PDUFA date for August 31, 2025. Deramiocel's Phase II and extension trials in over 250 DMD patients suggest this candidate has very favorable safety and efficacy for cardiomyopathy DMD.

Capricor's lead asset, deramiocel, targets DMD-related cardiomyopathy and faces key FDA milestones (ADCOM, PDUFA) in 2025. A strong cash position and partnership with Nippon Shinyaku provide financial stability but limit direct revenue potential from U.S. and Japan sales. Clinical data shows deramiocel slows disease progression by 52%, but regulatory approval and market adoption remain uncertain.

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Capricor Therapeutics, Inc. (NASDAQ:CAPR ) Q1 2025 Earnings Conference Call May 13, 2025 4:30 PM ET Company Participants A.J. Bergmann - Chief Financial Officer Linda Marban - Chief Executive Officer Conference Call Participants Ed Tenthoff - Piper Sandler Leland Gershell - Oppenheimer Kristen Kluska - Cantor Fitzgerald Catherine Novack - Jones Research Aydin Huseynov - Ladenburg Maanasa Sangee...

SAN DIEGO, May 06, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (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.

Capricor Therapeutics said on Monday the U.S. Food and Drug Administration (FDA) plans to convene a panel of outside experts before deciding on the company's cell therapy for a heart condition related to Duchenne muscular dystrophy (DMD).