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Catalyst Pharmaceuticals (CPRX) 8-KCatalyst Pharmaceuticals Enters Into an Exclusive License, Supply and Commercialization Agreement with Kye Pharmaceuticals for AGAMREE® in Canada

Filed: 26 Jul 24, 4:30pm

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): July 24, 2024

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 801
Coral Gables, Florida		33134
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (305) 420-3200

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))

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class

Name of Exchange

on Which Registered

Ticker

Symbol

Common Stock, par value $0.001 per share

NASDAQ Capital Market

CPRX

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

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 July 24, 2024, the Company issued a press release announcing that it has entered into a License, Supply and Commercialization Agreement with Kye Pharmaceuticals, Inc. (“Kye”), granting Kye the exclusive Canadian commercial rights to AGAMREE^® (vamorolone), a novel corticosteroid for the treatment of Duchenne Muscular Dystrophy (“DMD”) and potentially other indications. Under the terms of the agreement, the Company will supply the product to Kye, which will assume full responsibility for obtaining regulatory approval for AGAMREE^® for the treatment of DMD from Health Canada and all future aspects of commercialization of the product within Canada. Kye currently markets FIRDAPSE^®, the Company’s flagship product for the treatment of Lambert Eaton Myasthenic Syndrome, in Canada.

A copy of the press release is attached hereto as Exhibit 99.1.

Item 9.01

Financial Statements and Exhibits.

(d)

Exhibits


99.1		Press release issued by the Company on July 24, 2024.

104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

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/ Michael W. Kalb
		Michael W. Kalb
		Executive Vice President and Chief Financial Officer

Dated: July 26, 2024

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