FDA extends relutrigine PDUFA date by 3 months to Dec 27, 2026

Praxis Precision Medicines, Inc.

FDA extended relutrigine NDA review by 3 months due to additional sensitivity analyses submitted by Praxis.
New PDUFA target action date is December 27, 2026 (was September 27, 2026).
FDA deemed submission a major amendment; no new clinical studies, safety, or manufacturing concerns cited.
Company remains confident in application and continues preparations for launch.

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