Praxis Receives FDA Breakthrough Therapy Designation for Ulixacaltamide
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jul 17 2025
0mins
Should l Buy PRAX?
Praxis Precision Medicines Inc's stock surged by 15.61% as it crossed above the 5-day SMA, despite the broader market's decline with the Nasdaq-100 down 0.45% and the S&P 500 down 0.37%.
The significant price movement is attributed to Praxis receiving FDA Breakthrough Therapy Designation for its drug ulixacaltamide, based on positive topline results from the Essential3 program. This designation highlights the drug's potential to meet urgent treatment needs for essential tremor patients, with plans for a New Drug Application (NDA) submission expected in early 2026. The market's positive response reflects optimism regarding ulixacaltamide's development and its potential to capture a significant share of the multi-billion dollar market for essential tremor treatments.
This development not only enhances Praxis's competitive position in the neurology market but also boosts investor confidence, suggesting a promising outlook for the company's future revenue growth as it advances its drug pipeline.
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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: 328.040
Low
95.00
Averages
456.71
High
843.00
Current: 328.040
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.
Praxis Precision Medicines Set to Announce Q4 Earnings
- Earnings Announcement Schedule: Praxis Precision Medicines is set to release its Q4 earnings on February 19 before market open, with consensus EPS estimate at -$3.13 and revenue estimate at $0.26M, indicating challenges in profitability.
- Earnings Estimate Changes: Over the past three months, EPS estimates have seen three upward revisions and two downward adjustments, reflecting analysts' mixed views on the company's future performance, which may impact investor confidence.
- Stock Offering Plan: Praxis Precision Medicines has announced a proposed public stock offering of $575 million at a price of $260 per share, aimed at funding future research and operations, although this may dilute existing shareholders' stakes.
- Market Reaction Anticipation: With the upcoming earnings report and stock offering plan, market attention on Praxis is increasing, and investors should closely monitor the earnings results and their implications for the company's future strategy.
See More
Cormorant Increases MoonLake Stake Above 6%
- Stake Increase: Cormorant Asset Management disclosed on Tuesday that it has increased its stake in MoonLake Immunotherapeutics to 4.36 million shares, representing a 6.1% ownership, up from about 2 million shares in October 2025, indicating strong confidence in the company's future and potential stock price impact.
- Significant Stock Surge: Following the news of Cormorant's increased stake, MoonLake's shares jumped 11% on Tuesday, marking the largest rally in over a month, reflecting heightened market interest in a possible takeover and potentially attracting more investors.
- Market Sentiment Shift: Retail sentiment for MLTX on Stocktwits flipped from 'extremely bearish' to 'extremely bullish' with a 900% surge in message volume over 24 hours, indicating strong investor expectations for the company's future, which could further drive stock price increases.
- FDA Fast Track Progress: MoonLake's Sonelokimab received FDA Fast Track designation, with plans to pursue a biologics license application in the second half of 2026, highlighting the company's potential in the treatment space and likely drawing increased institutional investor interest in its long-term growth prospects.
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Affinity Asset Advisors Acquires New Stake in Praxis Precision Medicines
- 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.
See More
Affinity Asset Advisors Initiates Position in PRAX with 185,000 Shares
- 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.
See More
Soleus Capital Increases Stake in Celcuity
- 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.
See More
Praxis Precision Medicines to Report Q4 and Full Year 2025 Financial Results
- 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.
See More
Praxis Precision Medicines Set to Announce Q4 Earnings
- Earnings Announcement Schedule: Praxis Precision Medicines is set to release its Q4 earnings on February 19 before market open, with consensus EPS estimate at -$3.13 and revenue estimate at $0.26M, indicating challenges in profitability.
- Earnings Estimate Changes: Over the past three months, EPS estimates have seen three upward revisions and two downward adjustments, reflecting analysts' mixed views on the company's future performance, which may impact investor confidence.
- Stock Offering Plan: Praxis Precision Medicines has announced a proposed public stock offering of $575 million at a price of $260 per share, aimed at funding future research and operations, although this may dilute existing shareholders' stakes.
- Market Reaction Anticipation: With the upcoming earnings report and stock offering plan, market attention on Praxis is increasing, and investors should closely monitor the earnings results and their implications for the company's future strategy.
See More
Cormorant Increases MoonLake Stake Above 6%
- Stake Increase: Cormorant Asset Management disclosed on Tuesday that it has increased its stake in MoonLake Immunotherapeutics to 4.36 million shares, representing a 6.1% ownership, up from about 2 million shares in October 2025, indicating strong confidence in the company's future and potential stock price impact.
- Significant Stock Surge: Following the news of Cormorant's increased stake, MoonLake's shares jumped 11% on Tuesday, marking the largest rally in over a month, reflecting heightened market interest in a possible takeover and potentially attracting more investors.
- Market Sentiment Shift: Retail sentiment for MLTX on Stocktwits flipped from 'extremely bearish' to 'extremely bullish' with a 900% surge in message volume over 24 hours, indicating strong investor expectations for the company's future, which could further drive stock price increases.
- FDA Fast Track Progress: MoonLake's Sonelokimab received FDA Fast Track designation, with plans to pursue a biologics license application in the second half of 2026, highlighting the company's potential in the treatment space and likely drawing increased institutional investor interest in its long-term growth prospects.
See More
Affinity Asset Advisors Acquires New Stake in Praxis Precision Medicines
- 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.
See More
Affinity Asset Advisors Initiates Position in PRAX with 185,000 Shares
- 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.
See More
Soleus Capital Increases Stake in Celcuity
- 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.
See More
Praxis Precision Medicines to Report Q4 and Full Year 2025 Financial Results
- 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.
See More
