On February 17, 2026, Baker Bros. Advisors LP disclosed a buy of 437,000 Praxis Precision Medicines (NASDAQ:PRAX) shares, estimated at $81.38 million based on quarterly average pricing. What happened According to a recent SEC filing, Baker Bros. Advisors increased its stake in Praxis Precision Medicines by 437,000 shares during the fourth quarter of 2025. The estimated value of the transaction is $81.38 million, calculated using the period's average closing price. The post-trade stake stood at 1,126,488 ...

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]

Praxis Precision Medicines, Inc. (NASDAQ:PRAX) reported a wider-than-expected loss for the fourth quarter on Thursday.The company posted quarterly losses of $3.50 per share which missed the analyst consensus estimate of losses of $3.08 per share.Praxis Precision Medicine shares fell 0.1% to trade at $303.00 on Friday.These analysts made changes to their price targets on Praxis Precision Medicine following earnings announcement.Wedbush analyst Laura Chico maintained Praxis Precision Medicine with an Underper ...

Praxis Precision Medicines, Inc. (NASDAQ:PRAX) reported a wider-than-expected loss for the fourth quarter on Thursday.The company posted quarterly losses of $3.50 per share which missed the analyst consensus estimate of losses of $3.08 per share.Praxis Precision Medicine shares fell 0.1% to trade at $303.00 on Friday.These analysts made changes to their price targets on Praxis Precision Medicine following earnings announcement.Wedbush analyst Laura Chico maintained Praxis Precision Medicine with an Underper ...

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]

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 [16] - For the full year 2025, operating expenses reached $326 million, compared to $209 million in 2024 [16] - 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 net proceeds from a follow-on public offering [17] Business Line Data and Key Metrics Changes - Ulixacaltamide showed positive results in the Essential3 program, leading to an NDA submission for essential tremor, with a potential market of over $10 billion annually [7][8] - Relutrigine demonstrated significant efficacy in the EMBOLD study for SCN2A and SCN8A DEEs, with an addressable population of approximately 10,000 patients in the US, and potential annual revenue of $5 billion [9][10] - Vormatrigine achieved a 58% reduction in seizures at week 1 in the RADIANT phase 2 study, with potential annual revenue exceeding $4 billion [12] Market Data and Key Metrics Changes - The addressable population for ulixacaltamide in the US is estimated at 2 million patients with essential tremor [7] - The broader DEE population for relutrigine is over 200,000 patients, with ongoing studies to assess its efficacy [10] - The potential market for elsunersen is projected to exceed $1 billion annually, targeting gain-of-function SCN2A DEEs [15] Company Strategy and Development Direction - The company aims to transition into a commercial entity with two NDA submissions in early 2026 and plans for a robust commercial launch strategy [15] - Focus on building a commercial organization and preparing for product launches, including disease awareness campaigns [21][22] - The company is strategically prioritizing ulixacaltamide for a broader market while planning for relutrigine's expansion based on ongoing studies [43][32] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming year, highlighting the potential for significant revenue growth from their innovative pipeline [15] - The company is well-capitalized with approximately $1.5 billion in cash, expected to fund operations into 2028 [18] - Management emphasized the importance of a smooth review process with the FDA and the need for effective communication with prescribers [23][24] Other Important Information - The company plans to present extensive data at the upcoming American Academy of Neurology meeting, focusing on ulixacaltamide and relutrigine [24] - The EMBRAVE3 trial for elsunersen has been updated to a single-arm design, which management believes will enhance the understanding of the drug's impact [82] Q&A Session Summary Question: Can you walk us through the pre-commercial activities currently happening? - The company is making key hires and ensuring sufficient inventory for expected strong launches, particularly for ulixacaltamide [21] 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 [24] Question: What is the status of alternative titration schedules for relutrigine? - The FDA does not expect additional studies for alternative titration schedules, and the company is focused on ensuring the drug's tolerability [28] Question: How will the POWER3 study help move towards front-line settings? - The study aims to address the needs of a broader patient population with focal seizures, potentially moving vormatrigine to first-line treatment [40] Question: What are the review timelines for the NDAs? - The company has requested priority review for relutrigine but opted for standard review for ulixacaltamide due to strategic considerations [43]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from________ to_________ Commission File Number: 001-39620 PRAXIS PRECISION MEDICINES, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 47-5195942 (St ...

Financial Performance - The company reported a net loss of $303.3 million for the year ended December 31, 2025, compared to a net loss of $182.8 million in 2024[14]. - Net loss for the year ended December 2025 was $303,268,000, which is a 66% increase from the net loss of $182,819,000 in 2024[31]. - Net loss per share attributable to common stockholders was $13.48 for 2025, compared to $10.21 for 2024, indicating a 32% increase in loss per share[31]. - Collaboration revenue was $0 for the year ended December 2025, down from $8,553,000 in 2024, indicating a decline in collaboration activities[31]. - Total operating expenses for the year ended December 2025 were $326,198,000, a significant increase of 56% from $208,718,000 in 2024[31]. Cash and Investments - As of December 31, 2025, Praxis had $926.1 million in cash and investments, an increase of $456.6 million from $469.5 million in 2024, primarily due to net proceeds from a public offering[9][11]. - Cash and cash equivalents increased to $357,329,000 in December 2025 from $215,372,000 in December 2024, a growth of 66%[29]. - Marketable securities rose to $568,759,000 in December 2025, up from $254,156,000 in December 2024, representing a 124% increase[29]. - Total assets increased to $937,907,000 in December 2025 from $483,110,000 in December 2024, representing a growth of 94%[29]. Research and Development - Research and development expenses for the fourth quarter of 2025 were $77.5 million, up from $56.3 million in the same quarter of 2024, with a total of $267.1 million for the year[12]. - Research and development expenses rose to $267,115,000 for the year ended December 2025, up 75% from $152,413,000 in 2024[31]. - Praxis plans to nominate a development candidate for each of its three early-stage antisense oligonucleotide therapeutic initiatives in the first half of 2026[10]. Drug Development and Commercialization - Praxis submitted two new drug applications (NDA) for ulixacaltamide and relutrigine to the FDA, with pre-launch activities expected to accelerate through 2026[1][3]. - Ulixacaltamide is the first investigational therapy to show positive results in a Phase 3 program for essential tremor, with over 200,000 patients expressing interest in the Essential3 program[4][6]. - The revenue potential of the four assets in development, including ulixacaltamide and relutrigine, is estimated to exceed $20 billion[3]. - Enrollment in the EMERALD study for broad developmental and epileptic encephalopathies (DEEs) is expected to be completed in the second half of 2026[10]. - Praxis is preparing for the commercial launch of relutrigine, including hiring key commercial roles and building inventory[10]. - The POWER1 Phase 3 study for focal onset seizures completed enrollment and exceeded its original target, with topline results expected in Q2 2026[10].

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 ...