02:04 PM EST, 11/04/2025 (MT Newswires) -- Praxis Precision Medicines ( PRAX ) said Tuesday it reached alignment with the US Food and Drug Administration on several aspects of its relutrigine program for SCN2A and SCN8A developmental and epileptic encephalopathies following recent Breakthrough Therapy Designation discussions.

The two ultra-rare, life-threatening pediatric epilepsy disorders are characterized by early-onset, treatment-resistant seizures and severe neurodevelopmental decline, according to the company.

The FDA agreed that Praxis' proposed interim analysis from its 16-week Embold study, if positive, could serve as the basis for a New Drug Application submission.

Praxis said it plans to conduct the interim analysis of the Embold cohort 2 study in Q4.

Shares of Praxis Precision were up over 1% in recent trading.

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