Praxis Precision Medicines Receives FDA Breakthrough Therapy Designation, Stock Rises 13%
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 30 2025
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Source: NASDAQ.COM
- FDA Designation: Praxis Precision Medicines received Breakthrough Therapy Designation from the FDA for its experimental tremor treatment ulixacaltamide, based on promising results from two recent phase 3 studies, which will expedite the drug development process.
- Market Need: Approximately 7 million people in the U.S. suffer from essential tremor, with current treatment options being ineffective and poorly tolerated, making ulixacaltamide's development crucial to address this significant unmet medical need and potentially provide better treatment alternatives for patients.
- Stock Reaction: Following the Breakthrough Therapy Designation, Praxis's stock surged over 13% on Monday, reflecting market optimism regarding the prospects of its new therapy, which may attract more investor interest.
- Future Plans: Praxis plans to submit a New Drug Application for ulixacaltamide in early 2026, with CEO Marcio Souza stating that positive interactions with the FDA will accelerate the market entry of this promising treatment, further solidifying the company's position in the neurological disorder treatment space.
Analyst Views on PRAX
Wall Street analysts forecast PRAX stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for PRAX is 327.08 USD with a low forecast of 250.00 USD and a high forecast of 540.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
14 Analyst Rating
14 Buy
0 Hold
0 Sell
Strong Buy
Current: 294.380
Low
250.00
Averages
327.08
High
540.00
Current: 294.380
Low
250.00
Averages
327.08
High
540.00
About PRAX
Praxis Precision Medicines, Inc. is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal excitation-inhibition imbalance. The Company is applying genetic insights to the discovery and development of therapies for neurological disorders through two platforms, using its understanding of shared biological targets and circuits in the brain. Its platform includes Cerebrum, a small-molecule platform, which utilizes deep understanding of neuronal excitability and neuronal networks and applies a series of computational and experimental tools to develop orally available precision therapies, and Solidus, an antisense oligonucleotide platform, is an efficient, targeted precision medicine discovery and development engine anchored on a proprietary, computational methodology. The Company’s product candidates include ulixacaltamide, vormatrigine, relutrigine, PRAX-080, and others.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
