Company Overview - Praxis Precision Medicines is a Boston-based biotechnology company focused on developing novel therapies for neurological and psychiatric disorders characterized by neuronal imbalance [6] - The company has a pipeline targeting major depressive disorder, essential tremor, and rare epilepsies, emphasizing precision medicine and targeted treatments [6] - As of February 17, 2026, the company's stock price was $328.04, reflecting a significant increase of 320% over the prior year [8] Financial Performance - The company reported a trailing twelve months (TTM) revenue of $7.46 million and a net income loss of $273.04 million [4] - Praxis ended 2025 with $926 million in cash and investments, supplemented by an additional $621 million in financing in January 2026, extending its financial runway into 2028 [10][11] - Research and development spending for 2025 reached $267 million, indicating a late-stage push across multiple programs [11] Recent Developments - On February 17, 2026, Perceptive Advisors LLC disclosed a purchase of 431,432 shares of Praxis Precision Medicines, valued at approximately $80.34 million, increasing its stake significantly [2] - The quarter-end value of Perceptive Advisors' position in Praxis increased by $505.38 million due to the share purchase and subsequent stock price movement [2] - Praxis has submitted two New Drug Applications (NDAs) to the FDA for ulixacaltamide in essential tremor and relutrigine for SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs) [10] Market Position and Strategy - The company operates a biopharmaceutical business model focused on research, clinical development, and commercialization of proprietary drug candidates [9] - Praxis targets healthcare providers and specialists in neurology and psychiatry, aiming to address unmet medical needs in these fields [9] - The recent increase in portfolio weightings for Praxis reflects a transition from a pipeline story to a pending commercial launch, indicating potential for rapid changes in investor sentiment [7]

Financial Data and Key Metrics Changes - In Q4 2025, operating expenses totaled $97 million, up from $71.4 million in Q4 2024, with R&D expenses increasing from $56.3 million to $77.5 million and G&A expenses rising from $15.1 million to $19.5 million [17][18] - For the full year 2025, operating expenses reached $326 million, compared to $209 million in 2024, driven by increased spending on clinical programs [17][18] - The company ended Q4 2025 with $926 million in cash and equivalents, a significant increase from $469 million at the end of 2024, bolstered by proceeds from public offerings [18][19] Business Line Data and Key Metrics Changes - The ulixacaltamide program reported positive results from the Essential3 program, leading to an NDA submission for essential tremor, with a potential market of over $10 billion annually [9][10] - The relutrigine program for SCN2A and SCN8A DEEs has an initial addressable population of approximately 10,000 patients, with potential annual revenue estimated at $5 billion [12] - Vormatrigine demonstrated a 58% reduction in seizures at week 1 in the RADIANT phase 2 study, with potential annual revenue exceeding $4 billion [14] Market Data and Key Metrics Changes - The addressable population for ulixacaltamide in the U.S. is estimated at 2 million patients with essential tremor, while the broader DEE population for relutrigine is over 200,000 patients [9][12] - The company is preparing for a significant commercial launch, focusing on disease awareness and inventory management for ulixacaltamide and relutrigine [22][31] Company Strategy and Development Direction - The company aims to transform into a commercial entity, with plans to submit two NDAs and enhance its clinical portfolio in 2026 [5][6] - A comprehensive medical education campaign is planned for the upcoming American Academy of Neurology annual meeting to raise awareness about ulixacaltamide [10][25] - The company is focused on building a strong commercial organization and ensuring sufficient inventory for product launches [22][31] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming year, highlighting the potential for multiple readouts from the clinical pipeline and the importance of executing pre-commercial activities [16][17] - The company is well-capitalized with a strong balance sheet, expecting to fund operations into 2028 [19] - Management emphasized the importance of understanding the competitive landscape and the unmet needs in CNS disorders [10][12] Other Important Information - The company is planning an R&D day to discuss clinical programs and a commercial day to highlight launch strategies for ulixacaltamide and relutrigine [16] - Elsunersen is being developed for a rare genetic epilepsy, with a potential NDA submission expected next year [15][16] Q&A Session Summary Question: Can you walk us through the pre-commercial activities and cadence throughout 2026? - The company is making key hires and building inventory for strong launches, focusing on disease awareness for ulixacaltamide [22] Question: What additional new data can we expect at AAN? - The company will present about 15 different presentations, focusing on the Essential3 program and clinical data [25] Question: What is the status of alternative titration schedules for ulixacaltamide? - The company has proposed alternative titration schedules to the FDA and is awaiting their decision [29] Question: How much capital allocation should be expected between relutrigine and ulixacaltamide? - More allocation is expected for ulixacaltamide due to its broader market potential [31] Question: What is the review timeline for the NDAs? - The company has requested priority review for relutrigine but not for ulixacaltamide, considering strategic business reasons [43][44] Question: Can we expect long-term follow-up data at AAN? - The company plans to present long-term efficacy data to reinforce the value of ulixacaltamide [51] Question: What are the expectations for the EMBRAVE study? - The EMBRAVE study is expected to provide valuable data, with a focus on safety and efficacy [81][84]

Financial Data and Key Metrics Changes - In Q4 2025, operating expenses totaled $97 million, up from $71.4 million in Q4 2024, with R&D expenses at $77.5 million and G&A at $19.5 million [17] - For the full year 2025, operating expenses reached $326 million, compared to $209 million in 2024 [17] - The cash position at the end of Q4 2025 was $926 million, significantly increased from $469 million at the end of 2024, primarily due to proceeds from a follow-on public offering [18] Business Line Data and Key Metrics Changes - Ulixacaltamide showed positive results in the Essential3 program, with significant improvements in key endpoints, leading to a breakthrough designation from the FDA [8][9] - Relutrigine demonstrated strong efficacy in the EMBOLD study for SCN2A and SCN8A DEEs, with a potential annual revenue of $5 billion [12] - Vormatrigine achieved a 58% reduction in seizures at week 1 in the RADIANT phase 2 study, with expectations for multiple readouts in the next 12-18 months [13][14] Market Data and Key Metrics Changes - The addressable population for ulixacaltamide in the U.S. is estimated at 2 million patients with essential tremor, with a peak potential revenue of over $10 billion annually [9][10] - The initial addressable population for relutrigine is approximately 10,000 patients in the U.S., with a broader potential of over 200,000 patients with DEE [12] - Vormatrigine targets approximately 3 million people in the U.S. suffering from common epilepsies, with potential annual revenue exceeding $4 billion [14] Company Strategy and Development Direction - The company aims to transform into a commercial entity with two NDA submissions for ulixacaltamide and relutrigine, focusing on enhancing its clinical portfolio [6][16] - Preparations for the commercial launch of ulixacaltamide include building a commercial organization and a comprehensive medical education campaign [10][22] - The company is strategically focused on the U.S. market while acknowledging the unmet need for treatments outside the U.S. [86] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming year, highlighting a strong balance sheet and the potential for significant revenue opportunities across its CNS portfolio [17][19] - The company is positioned for a catalyst-rich year with multiple readouts from its innovative pipeline and plans for an R&D day to discuss clinical programs [16] - Management emphasized the importance of understanding the disease and clinical data for prescribers as part of their pre-commercial activities [24][25] Other Important Information - The company has initiated pre-launch activities for both ulixacaltamide and relutrigine, including key hires and inventory building [22][31] - The EMBRAVE3 trial for elsunersen has been updated to a single-arm, baseline-controlled study, with expectations for completion later this year [15][81] Q&A Session Summary Question: Can you walk us through the pre-commercial activities and cadence throughout 2026? - The company is making key hires and building inventory for strong launches, focusing on disease awareness and prescriber education [22] Question: What additional data can we expect at AAN? - The company will present about 15 different presentations, focusing on the Essential3 program and clinical data [25] Question: What is the status of alternative titration schedules for Relyxa? - The FDA did not require additional studies for alternative titration schedules, and the company is focused on ensuring the drug's tolerability [29][30] Question: How will the POWER3 study help move towards the front line setting? - The study aims to address the needs of a broader patient population with focal seizures, focusing on those who are not well managed with current treatments [40][41] Question: Why did you not request priority review for ulixacaltamide? - The decision was based on strategic considerations regarding launch timing and maximizing long-term revenue potential [43][44] Question: Can we expect long-term follow-up data at AAN? - The company plans to present multiple follow-up data points to reinforce the drug's value [51] Question: What is the expected utility of relutrigine across the DEE spectrum? - The company anticipates that relutrigine will serve as a foundational therapy for a diverse group of DEE patients [68][69]

Praxis Precision Medicines (NasdaqGS:PRAX) Q4 2025 Earnings call February 19, 2026 08:00 AM ET Speaker12Good day, and thank you for standing by. Welcome to the Praxis Precision Medicines fourth quarter and full year 2025 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one on your telephone. You will then hear an automated message advising y ...

Two new drug applications (NDA) for ulixacaltamide in essential tremor (ET) and for relutrigine in SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs) have been submitted to the U.S. Food and Drug Administration (FDA) Pre-launch activities for ulixacaltamide and relutrigine are underway and will accelerate through 2026 Essential3 results to be presented as an oral presentation at the American Academy of Neurology Annual Meeting Cash and investments of $926 million as of December 31, 2025 and ...

Group 1 - Praxis Precision Medicines Inc. (NASDAQ:PRAX) is recognized as one of the 13 stocks with significant upside potential, with Wells Fargo initiating coverage with an Equal Weight rating and a price target of $282, while noting a 50% probability of success for its investigational drug ulixacaltamide [1][3] - The company anticipates potential peak revenue of up to $20 billion over the next 24 months from four drugs, including $10 billion from ulixacaltamide, $5 billion from relutrigine, $4 billion from vormatrigine for epilepsy, and around $1 billion from elsunersen [2] - Praxis is a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system disorders characterized by neuronal excitation-inhibition imbalance [3]

Core Insights - Praxis Precision Medicines (NASDAQ:PRAX) is identified as one of the 17 biotechnology stocks with significant upside potential, with analysts projecting over 140% upside [1] - Guggenheim analyst Yatin Suneja raised the price target for PRAX from $760 to $800, maintaining a Buy rating based on the market adoption potential of ulixacaltamide in essential tremor, which supports a market opportunity exceeding $15 billion [2] - H.C. Wainwright analyst Douglas Tsao also raised the price target for PRAX from $340 to $1,245, indicating a revised upside potential of 274% [3] Product and Market Potential - Ulixacaltamide is considered transformative for Praxis, with peak sales projections ranging from $5 billion to $10 billion, while relutrigine is expected to drive significant value with peak sales reaching $6.8 billion [4] - The company focuses on developing therapies for central nervous system disorders characterized by neuronal excitation-inhibition imbalance, including epilepsy, movement disorders, and depression [5]

Core Insights - Praxis Precision Medicines is focused on developing therapies for central nervous system disorders, with candidates targeting conditions such as depression and epilepsy [1][9] - Affinity Asset Advisors disclosed a new position in Praxis, acquiring 185,000 shares valued at approximately $54.53 million [2][8] Company Overview - As of February 13, 2026, Praxis Precision Medicines had a market capitalization of $8.8 billion and a share price of $317.25, reflecting a 266.1% increase over the past year [4][8] - The company reported a total revenue of $7.46 million and a net income loss of $273.04 million for the trailing twelve months [4] Financial Position - The firm has approximately $956 million in pro forma cash and investments, which is expected to fund operations into 2028 [7] - The recent acquisition by Affinity Asset Advisors represents 3.11% of the fund's reportable assets [8] Strategic Developments - Praxis is in a critical phase, with expectations to submit two new drug applications for ulixacaltamide and relutrigine by mid-February, both of which have received Breakthrough Therapy Designation [7] - The company is leveraging a robust clinical pipeline and strategic collaborations to address significant gaps in neurological and psychiatric care [9] Market Performance - Praxis shares have significantly outperformed the S&P 500 by 254.29 percentage points over the past year [8] - The company is seen as transitioning from a focus on promise to potential commercialization, with an emphasis on regulatory milestones and cash discipline [11]

Core Insights - Praxis Precision Medicines is positioned for significant growth in 2026 with multiple product launches and a strong focus on commercial readiness for its therapies [2][4] - The company has a robust financial standing with $1.5 billion in pro forma cash and investments, supporting its pipeline and commercial activities [1][16] - Combined peak revenue estimates for four late-stage assets are projected to exceed $20 billion, indicating substantial market potential [1] Clinical and Regulatory Milestones - In 2025, Praxis achieved Breakthrough Therapy Designation from the FDA for ulixacaltamide and relutrigine, marking significant advancements in treating essential tremor and SCN2A/8A developmental and epileptic encephalopathies (DEEs) [2][3] - The company initiated four registration-enabling studies across its epilepsy portfolio, including pivotal studies for vormatrigine, relutrigine, and elsunersen [3] - Positive results were reported for ulixacaltamide in pivotal studies, establishing it as the first successful Phase 3 program for pharmacological treatment of essential tremor [3] Product Pipeline and Revenue Potential - Ulixacaltamide is expected to exceed $10 billion in peak revenues, while vormatrigine and relutrigine are projected to exceed $4 billion and $5 billion, respectively [10] - Elsunersen is anticipated to exceed $1 billion in peak revenues, highlighting the diverse revenue streams from the product pipeline [10] - The company plans to submit NDAs for ulixacaltamide and relutrigine by mid-February 2026, with significant pre-launch momentum and patient interest [10] Corporate Developments - Praxis has strengthened its leadership team to support growth, appointing new board members and promoting key executives [16] - The company completed a public offering resulting in net proceeds of approximately $621 million, enhancing its financial resources for upcoming initiatives [16] - A focus on lifecycle management and indication expansion across its portfolio is planned for 2026, reinforcing its position in the CNS market [10][15]

Core Insights - Praxis Precision Medicines, Inc. has announced key leadership appointments to enhance its strategic direction as it prepares for commercial launch and late-stage development [1][2] Leadership Appointments - Jeffrey B. Kindler has been appointed to the board, bringing extensive experience in enterprise leadership and strategic transactions from his tenure as former chairman and CEO of Pfizer [3] - Stuart Arbuckle joins the board with a strong background in global commercial success, having spent 13 years at Vertex Pharmaceuticals, where he played a pivotal role in the company's growth [5] - Megan Sniecinski has been promoted to Chief Operating Officer, responsible for operationalizing the company's growth strategy and overseeing program strategy and operations [8][9] - Dr. Steven Petrou has been promoted to President of Research & Development, reflecting the company's transition into late-stage development with multiple programs advancing toward commercialization [9][10] Strategic Vision - The leadership changes are aimed at optimizing value-creation pathways for Praxis as it enters a critical phase of growth, focusing on commercial launch planning and execution readiness [2][4] - The company is positioned to become a leading CNS company with a pipeline of multi-billion dollar drugs and innovative therapies targeting severe neurological disorders [7] Pipeline and Development - Praxis has a diversified CNS portfolio, including multiple clinical-stage product candidates, and is leveraging genetic insights to develop therapies for both rare and prevalent neurological disorders [12]