SEC Form 8-K filed by Catalyst Pharmaceuticals Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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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).
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| Item 8.01 | Other Events |
On September 24, 2024, the Company issued a press release announcing that its sub-licensee in Japan, DyDo Pharma, Inc. (“DyDo”), has reported that the Ministry of Health, Labor and Welfare of Japan has approved DyDo’s New Drug Application (“NDA”) to commercialize FIRDAPSE® (amifampridine) Tablets 10 mg for the treatment of patients with Lambert-Eaton myasthenic syndrome (“LEMS”) in Japan. Under the sub-license agreement between the Company and DyDo, upon approval of the NDA the Company has earned a milestone payment from DyDo in the amount of JPY 300 million (approximately $2.1 million USD based on current exchange rates).
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 September 24, 2024 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
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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/ Michael W. Kalb | |
| Michael W. Kalb | ||
| EVP, Treasurer and CFO | ||
Dated: September 26, 2024
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