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Praxis Precision Medicines Inc.

06/29/2026 | Press release | Distributed by Public on 06/29/2026 14:41

Material Event (Form 8-K)

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.

Praxis Precision Medicines Inc. published this content on June 29, 2026, and is solely responsible for the information contained herein. Distributed via EDGAR on June 29, 2026 at 20:41 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]