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CATALYST PHARMACEUTICALS, INC. Regulatory Filings 2016

Dec 8, 2016

31542_rns_2016-12-08_d5c4744d-fa0c-4607-9d8b-30a87b5d8f2b.zip

Regulatory Filings

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8-K 1 d271721d8k.htm FORM 8-K 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 8, 2016

CATALYST PHARMACEUTICALS, INC.

(Exact Name Of Registrant As Specified In Its Charter)

Delaware 001-33057 76-0837053
(State or other jurisdiction of incorporation) (Commission File Number) (I.R.S. Employer Identification No.)

| 355 Alhambra Circle Suite 1250 Coral Gables,

Florida 33134
(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (305) 529-2522

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 CFR240.14d-2(b))

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

Item 8.01 Other Events

On December 8, 2016, the Company issued a press release providing an update on its clinical trial with amifampridine phosphate (Firdapse®) in patients with congenital myasthenic syndromes (CMS). After discussions with the U.S. Food and Drug Administration, the study has been expanded beyond pediatric patients to include adult CMS patients and the enrollment size has been increased to approximately 20 patients. Further, there are now a total of five sites participating in the study.

A copy of the Company’s press release is attached as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

99.1 Press release issued by the Company on December 8, 2016.

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SIGNATURES

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

Catalyst Pharmaceuticals, Inc.
By: /s/ Alicia Grande
Alicia Grande
Vice President, Treasurer and CFO

Dated: December 8, 2016

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