Item 8.01 Other Events

On January 10, 2022, the Company issued a press release reporting that the 11th Circuit Court of Appeals has denied Jacobus Pharmaceutical Company Inc.'s petition for rehearing of the 11th Circuit's prior ruling to overturn the U.S. Food and Drug Administration (FDA) approval of Ruzurgi® for pediatric patients with Lambert-Eaton myasthenic syndrome (LEMS) based on the orphan drug exclusivity of FIRDAPSE®. The Company expects that the mandate to the District Court with instructions to enter summary judgment for the Company will be issued in the near future.

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 January 10, 2022.

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




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