Item 8.01. Other Events.
On April 14, 2026, Praxis Precision Medicines, Inc. announced that the U.S. Food and Drug Administration (the "FDA") has accepted for review its New Drug Application for ulixacaltamide HCl for the treatment of essential tremor in adults. The FDA has set a target action date under the Prescription Drug User Fee Act of January 29, 2027 and is not planning to hold an advisory committee meeting.