Praxis Wins FDA Breakthrough Status for Ulixacaltamide

The latest announcement is out from Praxis Precision Medicines ( (PRAX) ).

On December 29, 2025, Praxis Precision Medicines, Inc. reported that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to its investigational drug ulixacaltamide for the treatment of patients with essential tremor, a serious movement disorder. The designation, which is intended to speed development and regulatory review of promising therapies, was awarded on the strength of positive topline results from the company’s Essential3 program, comprising two pivotal Phase 3 studies, and marks a significant regulatory milestone that could accelerate ulixacaltamide’s path to market and potentially enhance Praxis’s competitive position in the neurology space.

The most recent analyst rating on (PRAX) stock is a Buy with a $843.00 price target. To see the full list of analyst forecasts on Praxis Precision Medicines stock, see the PRAX Stock Forecast page.

Spark’s Take on PRAX Stock

According to Spark, TipRanks’ AI Analyst, PRAX is a Neutral.

Praxis Precision Medicines’ overall stock score is driven by significant financial challenges, despite strong technical momentum and positive corporate developments. The financial performance is a major concern, but recent study successes and regulatory progress provide potential for future growth.

To see Spark’s full report on PRAX stock, click here.

More about Praxis Precision Medicines

Praxis Precision Medicines, Inc. is a biopharmaceutical company focused on developing novel therapies for central nervous system disorders, with a particular emphasis on conditions such as essential tremor where current treatment options are limited.

Average Trading Volume: 1,050,709

Technical Sentiment Signal: Buy

Current Market Cap: $6.73B

For a thorough assessment of PRAX stock, go to TipRanks’ Stock Analysis page.