Capricor Therapeutics Inc. (4LN2)
XFRA 
Summary
4LN2 Chart
Capricor Therapeutics shares tumble after FDA reviewers raise concerns over Duchenne therapy
Capricor Therapeutics (NASDAQ:CAPR) shares fell about 67% on Monday after US Food and Drug Administration (FDA) staff reviewers raised concerns about the evidence supporting the effectiveness of the company's experimental cell therapy, deramiocel, for Duchenne muscular dystrophy (DMD)-associated cardiomyopathy. The FDA released briefing documents ahead of a July 29 meeting of its Cellular, Tissue, and Gene Therapies Advisory Committee, which will review the therapy's efficacy and overall risk-benefit profile before the agency's August 22 Prescription Drug User Fee Act (PDUFA) target action date.
FDA staff flags concerns for Capricor's Duchenne heart disease therapy
U.S. Food and Drug Administration staff reviewers raised concerns about whether Capricor Therapeutics' cell therapy deramiocel has sufficient evidence of effectiveness for treating cardiomyopathy in Duchenne muscular dystrophy, according to briefing documents released on Monday.
Capricor Therapeutics Eyes FDA Approval Path for Duchenne Cell Therapy
Capricor Therapeutics NASDAQ: CAPR executives said the company is in active discussions with the U.S. Food and Drug Administration as it works toward a potential approval decision for deramiocel, its allogeneic cardiac-derived cell therapy for Duchenne muscular dystrophy.
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Capricor Therapeutics Inc. Profile
| Biotechnology Industry | Healthcare Sector | Linda Marbán CEO | XFRA Exchange | 14070B309 CUSIP |
| US Country | 231 Employees | 5 Jun 2019 Last Dividend | 5 Jun 2019 Last Split | 13 Feb 2007 IPO Date |
Overview
Capricor Therapeutics, Inc. is a clinical-stage biotechnology firm established in 2005, with its headquarters located in San Diego, California. The company is dedicated to the development of revolutionary cell and exosome-based therapeutics aimed at treating a variety of diseases that currently have unmet medical needs, with a particular focus on Duchenne Muscular Dystrophy (DMD). Through its advanced research and clinical trials, Capricor Therapeutics strives to bring innovative treatments to patients suffering from DMD and other serious conditions. The company has established several important collaborations and licensing agreements with prestigious institutions and companies, including Nippon Shinyaku Co. Ltd., National Institute of Allergy and Infectious Diseases, Johns Hopkins University, Cedars-Sinai Medical Center, and Life Technologies Corporation, to further its research and development efforts.
Products and Services
- CAP-1002
- StealthX
- CAP-2003
This allogeneic cardiac-derived cell therapy is Capricor Therapeutics’ leading candidate, specifically aimed at treating patients with late-stage Duchenne muscular dystrophy (DMD). Having completed phase 3 clinical trials, CAP-1002 represents a significant advancement in the quest for effective DMD therapies, showing promise in addressing the needs of patients suffering from this debilitating disease.
StealthX is an innovative engineered exosome-based vaccine candidate that is currently under phase 1 clinical study. This candidate is designed for a multitude of therapeutic applications, including the delivery of targeted RNA, proteins, and small molecule therapeutics. StealthX is aimed at treating or preventing a variety of diseases, showcasing Capricor’s dedication to leveraging cutting-edge science in its therapeutic development.
Currently in the pre-clinical development stage, CAP-2003 is being explored for its potential in treating trauma-related injuries and conditions. This further exemplifies Capricor Therapeutics’ commitment to expanding its portfolio of treatments and addressing a broader range of medical concerns that lack effective treatments.
