Capricor Therapeutics Inc. (CAPR)
Capricor Therapeutics, Inc. (CAPR) Q3 2025 Earnings Call Transcript
Capricor Therapeutics, Inc. ( CAPR ) Q3 2025 Earnings Call November 10, 2025 4:30 PM EST Company Participants Anthony Bergmann - CFO & Corporate Treasurer Linda Marbán - Co-Founder, President, CEO & Director Conference Call Participants Edward Tenthoff - Piper Sandler & Co., Research Division Leland Gershell - Oppenheimer & Co. Inc., Research Division Joseph Pantginis - H.C. Wainwright & Co, LLC, Research Division Kristen Kluska - Cantor Fitzgerald & Co., Research Division Catherine Novack - JonesTrading Institutional Services, LLC, Research Division Madison Wynne El-Saadi - B.
Capricor (CAPR) Moves 12.0% Higher: Will This Strength Last?
Capricor (CAPR) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.
Capricor Therapeutics, Inc. (CAPR) Q2 2025 Earnings Conference Call Transcript
Capricor Therapeutics, Inc. (NASDAQ:CAPR ) Q2 2025 Earnings Conference August 13, 2025 4:30 PM ET Company Participants Anthony J. Bergmann - CFO & Corporate Treasurer Linda Marbán - Co-Founder, President, CEO & Director Conference Call Participants Aydin Huseynov - Ladenburg Thalmann & Co. Inc., Research Division Catherine Clare Novack - JonesTrading Institutional Services, LLC, Research Division Edward Andrew Tenthoff - Piper Sandler & Co., Research Division Joseph Pantginis - H.C.
FDA Rejects CAPR's Cell Therapy BLA for Genetic Disorder, Stock Tanks
Capricor slumps 33% as the FDA rejects its BLA for DMD drug, deramiocel, citing lack of effectiveness data and CMC issues.
Capricor Therapeutics shares tumble as FDA rejects Duchenne muscular dystrophy drug application
Capricor Therapeutics (NASDAQ:CAPR) shares plummeted more than 26% after it reported the US Food and Drug Administration (FDA) has not approved its Biologics License Application for deramiocel, the company's lead cell therapy candidate for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). In a Complete Response Letter to Capricor, the FDA stated that the application did not meet the statutory requirement for substantial evidence of effectiveness and requested additional clinical data before reconsidering approval.
Capricor (CAPR) Moves 20.4% Higher: Will This Strength Last?
Capricor (CAPR) saw its shares surge in the last session with trading volume being higher than average. The latest trend in earnings estimate revisions may not translate into further price increase in the near term.
Capricor: A Hold Rating With Regulatory FDA Form Given For Deramiocel Advancement
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 additional risk, as both could be delayed and affect approval prospects.
Capricor Therapeutics' Buy Thesis Ahead Of Deramiocel PDUFA Date
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: High-Reward DMD Treatment Bet With Strong Data And Looming FDA Decision
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.
Capricor Therapeutics, Inc. (CAPR) Q1 2025 Earnings Conference Call Transcript
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 Sangeetha - Roth Capital Operator Good afternoon, ladies and gentlemen, and welcome to the Capricor Therapeutics First Quarter 2025 Earnings Call.
Capricor Therapeutics, Inc. (CAPR) Q4 2024 Earnings Call Transcript
Capricor Therapeutics, Inc. (NASDAQ:CAPR ) Q4 2024 Earnings Conference Call March 19, 2025 4:30 PM ET Company Participants A.J. Bergmann - Chief Financial Officer Linda Marban - Chief Executive Officer Conference Call Participants Edward Tenthoff - Piper Sandler Leland Gershell - Oppenheimer Joseph Pantginis - H.C.
Capricor Therapeutics (CAPR) Reports Q4 Loss, Tops Revenue Estimates
Capricor Therapeutics (CAPR) came out with a quarterly loss of $0.16 per share versus the Zacks Consensus Estimate of a loss of $0.31. This compares to loss of $0.02 per share a year ago.
