CAPRICOR THERAPEUTICS, INC. (NASDAQ:CAPR) Files An 8-K Regulation FD DisclosureItem 7.01
On February 5, 2018 Capricor Therapeutics, Inc., a Delaware corporation (the “Company”), issued a press release announcing that the FDA has granted the Company’s request for the Regenerative Medicine Advanced Therapy (RMAT) designation for CAP-1002 being developed for the treatment of Duchenne muscular dystrophy. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference into this Item 7.01 of this Current Report on Form 8-K.
The information contained in this Form 8-K (including Exhibit 99.1 attached hereto) is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
|Item 9.01.||Financial Statements and Exhibits.|
|99.1||Capricor Therapeutics, Inc. Press Release, dated February 5, 2018.|
CAPRICOR THERAPEUTICS, INC. ExhibitEX-99.1 2 tv484839_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Capricor Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Duchenne Muscular Dystrophy Therapy CAP-1002 to Benefit from Expedited Review Program for Drugs for Unmet Needs LOS ANGELES,…To view the full exhibit click
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.