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.
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 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.
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.
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.
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.
Capricor Therapeutics initiated its rolling BLA submission for Deramiocel to treat Duchenne Muscular Dystrophy Cardiomyopathy, with completion expected before the end of 2024. The company presented promising 3-year data from the HOPE-2 OLE study, showing significant improvements in cardiac and skeletal muscle functions. Capricor raised $86.3 million in a public offering, ensuring sufficient cash runway to fund operations into 2027, excluding potential milestone payments from Nippon Shinyaku.
Capricor Therapeutics, Inc. (NASDAQ:CAPR ) Q3 2024 Earnings Conference Call November 13, 2024 4:30 PM ET Company Participants A.J. Bergmann - Chief Financial Officer Linda Marbán - Chief Executive Officer Conference Call Participants Ted Tenthoff - Piper Sandler Leland Gershell - Oppenheimer Rick Miller - Cantor Fitzgerald Aydin Huseynov - Ladenburg Operator Good afternoon, ladies and gentlemen and welcome to the Capricor's Third Quarter 2024 Financial Results and Corporate Update Call.
Capricor Therapeutics (CAPR) came out with a quarterly loss of $0.38 per share versus the Zacks Consensus Estimate of a loss of $0.34. This compares to loss of $0.25 per share a year ago.
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Here is how Capricor Therapeutics (CAPR) and Hims & Hers Health, Inc. (HIMS) have performed compared to their sector so far this year.
Capricor (CAPR) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.