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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| Item 8.01 | Other Events |
On December 18, 2023, the Company issued a press release announcing that its collaboration partner in Japan, DyDo Pharma, Inc. (“DyDo”), reported that it has submitted a New Drug Application (“NDA”) to Japan’s Pharmaceuticals and Medical Devices Agency (“PMDA”) seeking marketing approval for FIRDAPSE® (amifampridine) Tablets 10 mg for the treatment of Lambert-Eaton myasthenic syndrome (“LEMS”) in Japan. The submission is based on preliminary favorable analysis results of interim data after six months into the safety phase of DyDo’s registration study to evaluate the efficacy and safety of FIRDAPSE® in Japanese patients with LEMS.
Under the license agreement between the Company and DyDo, upon acceptance of filing of the NDA, the Company will be due a milestone payment from DyDo of JPY 200 million (approximately $1.4 million USD based on current exchange rates). Further, upon acceptance of the NDA submission, the Company’s territorial rights to develop and market FIRDAPSE® will automatically extend to other key markets in Asia, Central and South America, and the Company is currently initiating plans to seek opportunities to expand FIRDAPSE®’s global footprint through strategic partnerships (with the current focus on the Asia Pacific and Latin America regions).
There can be no assurance whether DyDo’s clinical trial in Japan will ultimately be successful, whether FIRDAPSE® will ever be approved for commercialization in Japan, or whether the Company will be able to successfully expand FIRDAPSE®’s global footprint.
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 December 18, 2023. | |||
| 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/ Alicia Grande | |
| Alicia Grande | ||
| Vice President, Treasurer and CFO | ||
Dated: December 19, 2023
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