PRAX Praxis Precision Medicines, Inc. - 8-K

Item 8.01. Other Events.

On June 1, 2026, Praxis Precision Medicines, Inc. (the “Company”) announced results from the Phase 2/3 POWER1 study evaluating vormatrigine in patients with focal onset seizures (“FOS”). The POWER1 study in highly refractory patients with FOS did not meet its primary success measure. The secondary measure, the 50% response rate, was met and seizure reduction during the second half of the study on higher dose (30 mg) was more pronounced. Vormatrigine was generally well-tolerated and adverse event-related discontinuations were less than 10%. Approximately 90% of patients from the vormatrigine arm transitioned to and remain in the open label extension study.

The Company is pausing enrollment in the POWER2 study to reassess the vormatrigine program and determine potential modifications.

Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the clinical development of vormatrigine. The forward-looking statements included in this Current Report on Form 8-K are subject to a number of risks, including, without limitation, uncertainties inherent in clinical trials and other risks as described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 and other filings with the Securities and Exchange Commission. These statements are based only on facts currently known by the Company and speak only as of the date of this Current Report on Form 8-K. As a result, you are cautioned not to rely on these forward-looking statements and the Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.