0001144204-18-066148.txt : 20181226 0001144204-18-066148.hdr.sgml : 20181226 20181226060531 ACCESSION NUMBER: 0001144204-18-066148 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20181221 ITEM INFORMATION: Other Events FILED AS OF DATE: 20181226 DATE AS OF CHANGE: 20181226 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CAPRICOR THERAPEUTICS, INC. CENTRAL INDEX KEY: 0001133869 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-34058 FILM NUMBER: 181251170 BUSINESS ADDRESS: STREET 1: 8840 WILSHIRE BLVD STREET 2: 2ND FLOOR CITY: BEVERLY HILLS STATE: CA ZIP: 90211 BUSINESS PHONE: (310) 358-3200 MAIL ADDRESS: STREET 1: 8840 WILSHIRE BLVD STREET 2: 2ND FLOOR CITY: BEVERLY HILLS STATE: CA ZIP: 90211 FORMER COMPANY: FORMER CONFORMED NAME: Nile Therapeutics, Inc. DATE OF NAME CHANGE: 20070920 FORMER COMPANY: FORMER CONFORMED NAME: SMI PRODUCTS INC DATE OF NAME CHANGE: 20010206 8-K 1 tv509805_8k.htm FORM 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

________________________________

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported)

December 21, 2018

________________________________

CAPRICOR THERAPEUTICS, INC.

(Exact name of Registrant as Specified in its Charter)

Delaware		001-34058		88-0363465
(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification No.)

8840 Wilshire Blvd., 2nd Floor, Beverly Hills, CA

(Address of principal executive offices)

90211

(Zip Code)

(310) 358-3200

(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging growth company ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 8.01 Other Events.

On December 21, 2018, Capricor Therapeutics, Inc., a Delaware corporation (the “Company”), announced that it has put its HOPE-2 clinical trial on a voluntary dosing hold pending an ongoing safety review due to a severe allergic reaction that occurred during patient infusion of blinded investigational product. The patient responded well to medical treatment and is currently asymptomatic. The Company has notified the United States Food and Drug Administration (the “FDA”) about this issue and is working closely with the FDA on a mitigation plan.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.

	CAPRICOR THERAPEUTICS, INC.

Date: December 21, 2018	By:	/s/ Linda Marbán, Ph.D.
		Linda Marbán, Ph.D.
		Chief Executive Officer