FDA extends review of Praxis drug for rare epilepsy to December 2026

Praxis Precision Medicines (NASDAQ: PRAX) said the U.S. Food and Drug Administration has extended by three months its review of the company's New Drug Application for relutrigine, a drug candidate for SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs).

The updated Prescription Drug User Fee Act (PDUFA) target action date is now December 27, 2026, moved from the previous date of September 27, 2026.

According to the company, the extension follows Praxis's submission of additional sensitivity analyses of existing clinical data, which the FDA classified as a "major amendment," requiring additional review time. The FDA did not request new clinical studies and did not cite safety or manufacturing concerns. The review remains active.

"Relutrigine has demonstrated a compelling profile, and we have every confidence in the strength of the data package to benefit patients with SCN2A and SCN8A DEEs," said Marcio Souza, president and chief executive officer of Praxis.

The information is based on a press release issued by Praxis Precision Medicines.

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