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 March 11, 2022, Catalyst issued a press release announcing receipt of a favorable decision from the Federal Court of Canada (“Court”) setting aside, for the second time, the decision of Canada’s national healthcare regulatory agency, Health Canada, approving Ruzurgi® (amifampridine) for the treatment of Lambert-Eaton Myasthenic Syndrome (“LEMS”) patients. This decision sets aside the Notice of Compliance (“NOC”) issued by Health Canada for Ruzurgi due to the inclusion of data developed for FIRDAPSE®, which is protected from such use by FIRDAPSE’s status as an Innovative Drug in Canada. Drugs that qualify as Innovative Drugs are protected by regulation from other parties using their data as part of their submissions seeking an NOC for eight years from approval of the Innovative Drug. The Court determined that the Minister’s approach to evaluating whether FIRDAPSE data deserved such protection was legally flawed and not supported by the evidence.
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 March 11, 2022. | |
| 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: March 11, 2022
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