CAPRICOR THERAPEUTICS, INC. (NASDAQ:CAPR) Files An 8-K Other Events
Item 8.01
On May 13, 2020, Capricor Therapeutics, Inc. (the “Company”) announced positive top-line results from the HOPE-2 trial. The one-year results demonstrated clinically meaningful benefits in multiple parameters of upper limb and cardiac function. HOPE-2 is a randomized, double-blind, placebo-controlled, Phase II clinical trial of CAP-1002 (allogeneic cardiosphere-derived cells) in steroid-treated boys and young men who are in advanced stages of Duchenne muscular dystrophy, or DMD. The Company has requested an End-of-Phase 2 meeting with the FDA to discuss the next steps and pathway to approval of a Biologics License Application for CAP-1002 in DMD.
A press release announcing the results is included as Exhibit 99.1 and is incorporated herein by reference.
(d) Exhibits
| 99.1 | Press Release, titled “Capricor Announces Positive Top-Line Results from HOPE-2 Study in Patients with Duchenne Muscular Dystrophy Treated with Lead Candidate CAP-1002”, dated May 13, 2020. |
CAPRICOR THERAPEUTICS, INC. Exhibit
EX-99.1 2 tm2019534d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Capricor Announces Positive Top-Line Final Results from HOPE-2 Study in Patients with Duchenne Muscular Dystrophy Treated with Lead Candidate CAP-1002 -One-Year Results from Randomized,…
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About CAPRICOR THERAPEUTICS, INC. (NASDAQ:CAPR)
Capricor Therapeutics, Inc. is a clinical-stage biotechnology company focused on the discovery, development and commercialization of therapeutics. The Company focuses on discovering, developing and commercializing regenerative medicine and large molecule products for the treatment of disease, with a primary focus on the treatment of cardiovascular diseases, including orphan indications. Its product candidate, CAP-1002, a cardiosphere-derived cell product, is being tested in the ALLSTAR Phase II clinical study on patients having suffered a myocardial infarction (MI), while the DYNAMIC clinical study is testing CAP-1002 in patients in the advanced-stage of heart failure. CAP-1002 is also being tested in the HOPE-Duchenne Phase I/II clinical study for use in connection with Duchenne muscular dystrophy-related cardiomyopathy. Cenderitide, a dual receptor natriuretic peptide agonist, is being tested in a Phase II clinical study. Exosomes are nano-sized, membrane-enclosed vesicles.
