Capricor Therapeutics Inc. (CAPR)
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.
Capricor: Further Value Unlocked With Priority Review Of Deramiocel
Capricor Therapeutics, Inc.'s Deramiocel received FDA Priority Review with a PDUFA target date of August 31, 2025, for the treatment of patients with DMD Cardiomyopathy. Deramiocel could become the first FDA-approved drug for DMD cardiomyopathy patients, targeting a group of patients with no currently available treatment options. The StealthX exosome platform from the company shows promise, potentially enhancing drug delivery and gene expression inhibition for DMD patients by possibly providing 2.5X greater exon skipping.
Capricor Therapeutics Cell Therapy Goes Under Priority FDA Review For Duchenne Associated-Heart Condition
On Tuesday, the FDA accepted for review Capricor Therapeutics Inc's CAPR Biologics License Application for deramiocel, an investigational cell therapy, as a treatment for patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy.
Capricor Therapeutics: Heavily Derisked After BLA Submission And OLE Data
Capricor Therapeutics has filed a BLA for deramiocel, showing promising results in slowing cardiac dysfunction in DMD cardiomyopathy, with strong FDA recognition. Deramiocel's efficacy was demonstrated in the HOPE-2 trials, with significant improvements in PUL 1.2 scores and positive long-term benefits in PUL 2.0 and LVEF measures. Financially, Capricor is well-positioned with a strong cash runway, strategic partnerships, and projected significant revenue from deramiocel sales by 2030.
Wall Street Analysts Believe Capricor (CAPR) Could Rally 208.09%: Here's is How to Trade
The consensus price target hints at a 208.1% upside potential for Capricor (CAPR). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.
CAPR Stock Up on Completion of Rolling Submission of DMD Drug BLA
Capricor stock gains 8% upon completing the rolling submission of the BLA for its lead asset, deramiocel, to treat DMD cardiomyopathy in the United States.
Deramiocel's Promise Brightens Capricor's Outlook, With Strings Attached
Capricor Therapeutics is advancing deramiocel, an allogeneic cell therapy for DMD-related cardiomyopathy, with a rolling BLA submission and potential FDA approval by 2025. Deramiocel showed significant improvements in upper limb function and LVEF in Phase 2 trials, with ongoing open-label extension trials supporting long-term efficacy and safety. Despite promising prospects, Capricor's upside is limited due to prior commercialization deals, but the stock remains attractively valued with potential milestone payments and royalties.
