Item 8.01. Other Events.

On the afternoon of May 10, 2022, Takeda Pharmaceutical Company Limited ("Takeda") notified Ovid Therapeutics Inc. (the "Company") that Takeda planned to announce that two pivotal Phase 3 programs evaluating soticlestat for the potential treatment of Dravet and Lennox-Gastaut syndromes are likely to be delayed due to enrollment challenges specifically related to the geopolitical situation in Ukraine and Russia and Covid-19 lockdowns in China. Takeda disclosed it is working on multiple approaches to minimize delays, accelerate recruitment and optimize regulatory timelines for the soticlestat programs. Takeda stated that the studies are actively recruiting patients and remain one of Takeda's highest priority, late-stage, programs. Takeda estimated on its annual earnings call, held on May 11, 2022, that the primary completion date for the soticlestat studies will be March 2024 and anticipates regulatory filings in its fiscal 2024.

The Company maintains a significant financial interest in the future regulatory development and potential commercialization of soticlestat, which Takeda is responsible for advancing globally. Soticlestat is a cholesterol 24 hydroxylase inhibitor, which is currently in Phase 3 trials for Dravet and Lennox-Gastaut syndromes.

Item 9.01. Financial Statements and Exhibits.



(d) Exhibit

Exhibit No.   Description

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

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