Overview
Praxis Precision Medicines Inc. (NASDAQ: PRAX) announced that the U.S. Food and Drug Administration has extended the review period for its New Drug Application (NDA) for relutrigine by three months.
FDA Decision
The FDA moved the PDUFA target action date from September 27, 2026 to December 27, 2026. The extension was triggered after Praxis submitted additional sensitivity analyses of existing clinical data, which the agency classified as a “major amendment.” The FDA did not request any new clinical studies and did not raise safety or manufacturing concerns. The review remains active and ongoing.
Product Information
Relutrigine is being evaluated for the treatment of developmental and epileptic encephalopathies associated with SCN2A and SCN8A gene mutations. No FDA‑approved therapies currently exist for these conditions.
Market Reaction
Following the announcement, Praxis shares fell approximately 7 % in after‑hours trading on Monday.
Management Comment
Marcio Souza, President and Chief Executive Officer, said the company remains confident in the strength of its data package and will continue to work closely with the FDA review team. Praxis also indicated it is preparing to deliver relutrigine to patients once approval is obtained.