Praxis Precision Medicines Receives FDA Breakthrough Therapy Designation, Stock Rises 13%
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 30 2025
0mins
Should l Buy PRAX?
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.
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Analyst Views on PRAX
Wall Street analysts forecast PRAX stock price to rise
15 Analyst Rating
14 Buy
0 Hold
1 Sell
Strong Buy
Current: 332.920
Low
95.00
Averages
456.71
High
843.00
Current: 332.920
Low
95.00
Averages
456.71
High
843.00
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.
- New Investment Disclosure: Affinity Asset Advisors disclosed a new position in PRAX, acquiring 185,000 shares valued at approximately $54.53 million in Q4 2026, indicating confidence in the company's future prospects.
- Asset Allocation Insight: This acquisition positions PRAX to represent 3.11% of Affinity's reportable 13F assets, highlighting its significance within the portfolio despite not being among the top five holdings.
- R&D Progress: Praxis Precision Medicines is at a pivotal moment, expecting to submit two new drug applications by mid-February, with the CEO noting that both drugs have shown compelling late-stage results and received Breakthrough Therapy Designation, potentially driving future growth.
- Financial Overview: Praxis reported approximately $956 million in cash and investments, expected to fund operations into 2028, although R&D expenses rose to $65.8 million and net losses widened to $73.9 million, the advancement of multiple clinical programs lays a foundation for future commercialization.
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- New Investment Disclosure: On February 13, 2026, Affinity Asset Advisors disclosed a new position by acquiring 185,000 shares of Praxis Precision Medicines in an estimated $54.53 million trade, indicating strong confidence in the company's future potential.
- Significant Stake: This acquisition accounts for 3.11% of Affinity's reportable assets in its 13F filing, reflecting the fund's keen interest in the biotech sector and diversification of its investment portfolio.
- Outstanding Stock Performance: As of February 13, 2026, Praxis shares were priced at $317.25, up 266.1% over the past year, significantly outperforming the S&P 500 by 254.29 percentage points, showcasing strong market recognition of its clinical pipeline.
- Increased R&D Spending: Praxis reported a third-quarter R&D expense of $65.8 million, with a net loss widening to $73.9 million; however, its multiple late-stage projects provide several commercialization opportunities, highlighting the company's potential in drug development.
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- Share Increase: Soleus Capital Management disclosed a purchase of 629,398 shares of Celcuity in an SEC filing, raising its total holdings to over 1.8 million shares valued at $180.36 million, indicating strong confidence in the company.
- Asset Allocation Shift: Celcuity now accounts for 6.7% of Soleus Capital's AUM, becoming its third-largest holding among 95 positions, reflecting investor interest in the biotechnology sector.
- Stock Performance: Celcuity's stock price surged 745% over the past year, significantly outperforming the S&P 500's 14.4% and NASDAQ Composite's 15.7%, highlighting strong market expectations for its future potential.
- Risk Advisory: Despite Celcuity's impressive stock performance, the company currently generates no revenue, necessitating caution from investors regarding inherent risks, as the stock's value is heavily reliant on drug approvals and future profitability prospects.
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- Earnings Report Schedule: Praxis Precision Medicines is set to announce its Q4 and full year 2025 financial results on February 19, 2026, before the market opens, which is expected to impact investor confidence positively.
- Conference Call Details: The company will host a conference call and live webcast at 8:00 AM ET on February 19, 2026, to review financial results in detail, enhancing transparency and attracting investor attention.
- Investor Conference Participation: Praxis will present at the Guggenheim Emerging Outlook: Biotech Summit 2026 on February 11 in New York City, further elevating its profile in the biotechnology sector.
- Upcoming Event Schedule: The company will also participate in the TD Cowen 46th Annual Health Care Conference on March 2, showcasing its diversified CNS product portfolio, which is expected to draw more investor interest.
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- Leadership Change: Praxis Precision Medicines has appointed renowned neurologist Dr. Orrin Devinsky as the Head of Clinical Strategy, a move that signifies a strategic deepening in the neuroscience field and is expected to accelerate the commercialization of its late-stage product portfolio.
- Industry Influence: With over four decades of experience in epilepsy and clinical neuroscience, Devinsky has led pivotal clinical trials that have driven the development of transformative therapies, bringing invaluable expertise and industry influence to Praxis.
- Scientific Contributions: Devinsky's extensive background includes over 500 peer-reviewed publications and 16 patents in epilepsy therapeutics and drug delivery, enhancing Praxis's strength in scientific research and clinical development, positioning the company to stand out in a competitive market.
- Strategic Vision: Devinsky expressed that Praxis's scientific rigor and commitment to patients set it apart in the industry, and his involvement will help guide the company's innovations in epilepsy treatment, advancing new therapies aimed at improving patient quality of life.
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- Employee Incentive Program: On January 2, 2026, Praxis granted 434 restricted stock units to three new non-executive employees under the 2024 Inducement Plan, aimed at attracting talent in accordance with Nasdaq Listing Rule 5635(c)(4).
- Equity Incentive Structure: These restricted stock units will vest in four equal annual installments, contingent upon the employee's continued employment with Praxis on each vesting date, thereby ensuring long-term commitment aligned with the company's growth.
- Talent Acquisition Strategy: The plan is exclusively designed to attract individuals who were not previously employed by Praxis, reflecting the company's proactive stance in talent competition and aiming to enhance its R&D capabilities in CNS disorder treatments.
- Business Development Potential: By implementing such equity incentives, Praxis not only attracts high-quality talent but also enhances its market competitiveness in the rapidly evolving biopharmaceutical industry, driving future innovation and growth for the company.
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