Praxis Stock Surges On FDA Breakthrough Status For Essential Tremor Drug

Praxis Precision Medicines Inc. (NASDAQ:PRAX) stock rose Monday after the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for ulixacaltamide for essential tremor (ET).

Essential Tremor is the most common movement disorder, affecting roughly seven million people in the United States alone, representing a multi-billion dollar commercial opportunity.

ET is characterized by involuntary rhythmic movement in the upper limbs, with or without tremor in other body locations such as the head, vocal cords, or legs.

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“We recently completed a series of positive interactions with the FDA, that, together with this BTD, are enabling us to advance this promising treatment faster to patients. We are diligently preparing for the filing of the ulixacaltamide NDA, which we expect in early 2026,” said Marcio Souza, president and CEO.

The BTD enables expedited development and regulatory review for drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies.

The BTD for ulixacaltamide was based on the positive topline data from the Essential3 program, consisting of two pivotal Phase 3 studies of ulixacaltamide in ET.

In December 2025, Praxis completed its pre-NDA meeting with the FDA, including the receipt of written feedback and an in-person meeting.

The company has aligned with the FDA on the content of the NDA and expects to submit the ulixacaltamide NDA in early 2026.

PRAX Price Action: Praxis Precision Medicine shares were up 14.24% at $318.08 at the time of publication on Monday. The stock is trading at a new 52-week high, according to Benzinga Pro data.

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