Capricor Therapeutics Inc
F:4LN2
Decide at what price you'd be comfortable buying and we'll help you stay ready.
|
Capricor Therapeutics Inc
F:4LN2
|
US |
|
Technoprobe SpA
OTC:THNBY
|
IT |
|
V
|
Vale SA
SWB:CVLC
|
BR |
|
Q
|
Qiagen NV
XHAM:QIA
|
NL |
Capricor Therapeutics Inc
Capricor Therapeutics is a biotechnology company that develops cell-based medicines for serious diseases, with a main focus on heart and muscle disorders. Its lead program is deramiocel, an allogeneic cardiosphere-derived cell therapy being studied for Duchenne muscular dystrophy, a genetic disease that weakens muscles over time. The company also works on exosome-based therapies, which use tiny particles released by cells as a way to deliver treatment signals. The company does not sell a broad range of drugs. It earns money mainly through research and development funding, collaboration payments, and, if its programs succeed, potential future product sales or licensing deals. Its main customers are not typical consumers; they are regulators, research partners, doctors, hospitals, and eventually patients and payers if a therapy reaches the market. What makes Capricor different is that it sits very early in the drug-development chain and focuses on hard-to-treat rare diseases where standard medicines often do not help enough. Instead of making mass-market pills, it is building specialized biologic treatments that must be tested, approved, and then delivered through clinical and medical channels.
Capricor Therapeutics is a biotechnology company that develops cell-based medicines for serious diseases, with a main focus on heart and muscle disorders. Its lead program is deramiocel, an allogeneic cardiosphere-derived cell therapy being studied for Duchenne muscular dystrophy, a genetic disease that weakens muscles over time. The company also works on exosome-based therapies, which use tiny particles released by cells as a way to deliver treatment signals.
The company does not sell a broad range of drugs. It earns money mainly through research and development funding, collaboration payments, and, if its programs succeed, potential future product sales or licensing deals. Its main customers are not typical consumers; they are regulators, research partners, doctors, hospitals, and eventually patients and payers if a therapy reaches the market.
What makes Capricor different is that it sits very early in the drug-development chain and focuses on hard-to-treat rare diseases where standard medicines often do not help enough. Instead of making mass-market pills, it is building specialized biologic treatments that must be tested, approved, and then delivered through clinical and medical channels.
Regulatory: Capricor said deramiocel’s BLA is under active FDA review with a PDUFA target date of August 22, 2026, and management said the FDA has accepted the resubmission as Class II after the prior CRL.
Clinical data: Management highlighted HOPE-3 results, saying the trial met its primary endpoint and key secondary endpoints, including cardiac measures that they believe support the DMD cardiomyopathy indication.
Legal fight: Capricor filed suit against NS Pharma and Nippon Shinyaku to try to unwind their distribution deal, arguing the pricing structure would make broad patient access economically impossible.
Launch plan: The company said it is now building its own commercial organization, manufacturing setup, and distribution infrastructure in case it launches deramiocel itself.
Finances: Capricor ended the quarter with about $279 million in cash and said that is enough to fund operations into the fourth quarter of 2027, excluding product revenue or a PRV sale.
Pipeline: Beyond Duchenne, Capricor said it is planning future discussions with FDA on Becker muscular dystrophy and is also pursuing exosome-based programs, while stepping away from vaccine development for now.
