PRAX: Other company developments

Item 8.01. Other Events. On June 29, 2026, Praxis Precision Medicines, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (the “FDA”) notified the Company that it has extended by three months the review period for its New Drug Application (“NDA”) for relutrigine for the treatment of SCN2A and SCN8A developmental and epileptic encephalopathies (“DEEs”), setting an updated PDUFA target action date from September 27, 2026 to December 27, 2026. The extension follows the Company’s submission of additional sensitivity analyses of existing clinical data, which the FDA has deemed a “major amendment,” allowing additional time for the FDA to review. No new clinical studies were requested, and the FDA did not cite any safety or manufacturing concerns. The review remains active and ongoing, and the Company is continuing its preparations to bring relutrigine to a patient community with significant unmet need. The Company remains confident in the strength of the relutrigine application and continues to collaborate with the FDA to support the completion of its review. 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 anticipated timing of regulatory review and interactions and the commercial potential of the Company’s product candidates, including relutrigine. 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 Se