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 net proceeds of $621 million from January 2026 public offering fund operations into 2028

Conference call today, February 19, 2026 at 8:00 am E.T.

BOSTON, Feb. 19, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a fully integrated, leading central nervous system $(CNS)$ precision neuroscience biopharmaceutical company, today provided a corporate update and reported financial results for the fourth quarter and full-year 2025.

"After a landmark fourth quarter, filled with a breadth of clinical and regulatory advancements across our portfolio, we started 2026 with two NDA submissions for ulixacaltamide and relutrigine. Pending their expected positive reviews, we will be positioned to transition into a commercial company," said Marcio Souza, president and chief executive officer. "The other two programs in the clinic, vormatrigine and elsunersen, will both have topline results in the first half of 2026, keeping us on track for additional NDA submissions in the next two years. Together, these four assets have a revenue potential of over $20 billion."

Recent Highlights and Anticipated Milestones

Cerebrum$(TM)$ Small Molecule Platform

Ulixacaltamide for Essential Tremor (ET): ET is one of the most common movement disorders, affecting approximately seven million patients in the U.S., yet it is inadequately managed and undertreated with no specific drugs developed for ET currently approved, as underscored by the interest from over 200,000 patients in the Essential3 program. Ulixacaltamide was the first investigational therapy to demonstrate positive results in a Phase 3 program in ET and was granted Breakthrough Therapy Designation by the FDA in December 2025.

   -- In October 2025, Praxis announced positive topline results from both 
      Phase 3 studies in the ESSENTIAL3 program. 
 
   -- Following a positive pre-NDA meeting with the FDA in December 2025, 
      Praxis has submitted an NDA for the treatment of ET. 
 
   -- Praxis will present several oral presentations and posters on 
      ulixacaltamide at the upcoming American Academy of Neurology $(AAN)$ Annual 
      Meeting, taking place April 19 to 22, 2026 in Chicago, IL. 
 
   -- Commercial preparations and pre-launch activities are well underway and 
      will accelerate through 2026. Praxis is scaling its commercial 
      organization, advancing launch readiness efforts, building inventory, and 
      will initiate its disease awareness campaign in conjunction with the AAN 
      meeting. 

Relutrigine for DEEs: Relutrigine is a sodium channel modulator designed to precisely target the hyperexcitable state of sodium-channels, with therapeutic potential across developmental epilepsies. Relutrigine has been granted Breakthrough Therapy Designation and Orphan Drug Designation by the FDA.

   -- Praxis has submitted an NDA for relutrigine for the treatment of SCN2A 
      and SCN8A DEEs based on the strong efficacy observed in the EMBOLD 
      registrational cohort. The results of the trial were shared at the 2025 
      AES meeting. 
 
   -- Enrollment in the EMERALD study in broad DEEs is progressing well and is 
      expected to be fully enrolled in the second half of 2026. Assuming 
      successful initial NDA approval of relutrigine, the EMERALD study, if 
      positive, would serve as the basis for a supplemental NDA submission in 
      2027. 
 
   -- Praxis has begun preparations for the commercial launch of relutrigine, 
      including hiring key commercial roles, building sufficient inventory for 
      launch and preparing and executing key pre-launch activities, which are 
      expected to accelerate throughout 2026. 

Vormatrigine for Focal Onset Seizures (FOS) and Generalized Epilepsy: An estimated 3.5 million people in the U.S. suffer from common epilepsies. Sodium channel therapy is the cornerstone of treatment for patients with epilepsy, yet currently approved drugs have significant safety and efficacy limitations. Vormatrigine is the most potent sodium-channel modulator ever developed for epilepsy and is designed to precisely target the hyperexcitable state of sodium-channels in adult common epilepsies.

   -- The full dataset from the RADIANT Phase 2 study were presented at the 
      2025 American Epilepsy Society Annual Meeting, positioning vormatrigine 
      as a best-in-disease therapy. Study results showed its fast-acting 
      efficacy without titration, sustained seizure reduction over longer 
      treatment duration, seizure-freedom potential, and favorable DDI, 
      tolerability and safety profiles with once-daily dosing. 
 
   -- The POWER1 Phase 3 study for FOS completed enrollment and exceeded its 
      original target; topline results are expected in the second quarter of 
      2026. 
 
   -- POWER2, the second Phase 3 study for vormatrigine in FOS, is enrolling 
      patients, with completion expected in the second half of 2026 and topline 
      results anticipated in 2027. 
 
   -- The POWER3 study to evaluate vormatrigine as a monotherapy is on track to 
      commence in the first half of 2026. 

Solidus(TM) Antisense Oligonucleotide $(ASO)$ Platform

   -- Elsunersen for early-seizure-onset SCN2A DEE: SCN2A Gain-of-function 
      (GoF)-DEE is a rare, genetic epilepsy characterized by early-onset 
      seizures and severe impact on development. 
 
          -- The EMBRAVE Part A Phase 1/2 study evaluating SCN2A early seizure 
             onset patients with a 3:1 drug to sham arm evaluating safety and 
             seizure reduction is on track for topline results in the first 
             half of 2026. 
 
          -- In December 2025, Praxis shared that after a favorable meeting 
             with the FDA there was agreement to update the EMBRAVE3 
             registrational trial design by removing the sham control arm. 
             Enrollment is underway, with topline results expected in 2027. 
 
   -- Praxis remains on track to nominate a development candidate for each of 
      its three early stage ASO therapeutic initiatives in the first half of 
      2026: 
 
          -- PRAX-080 is focused on targeting PCDH19 mosaic expression disorder 
 
          -- PRAX-090 is designed to address SYNGAP1 loss-of-function (LoF) 
             mutations, a leading cause of severe intellectual disability and 
             epilepsy in DEEs. 
 
          -- PRAX-100 targets SCN2A LoF mutations, the predominant genetic link 
             to de novo autism spectrum disorders. 

Corporate Updates:

In January 2026, Praxis announced updates to its board of directors, key promotions and additions to the company:

   -- Jeffrey B. Kindler and Stuart Arbuckle joined the Board of Directors. 
 
   -- Promoted Megan Sniecinski to Chief Operating Officer and Steven Petrou, 
      Ph.D. to President of Research & Development. 
 
   -- Appointed Orrin Devinsky, M.D., a global epilepsy leader, as Head of 
      Clinical Strategy. 

Fourth Quarter and Full Year 2025 Financial Results:

As of December 31, 2025, Praxis had $926.1 million in cash, cash equivalents and marketable securities, compared to $469.5 million in cash, cash equivalents and marketable securities as of December 31, 2024. This increase of $456.6 million was primarily due to net proceeds from Praxis' October 2025 follow-on public offering and net proceeds from at-the-market sales of common stock, partially offset by cash used in operations. The Company's cash, cash equivalents and marketable securities as of December 31, 2025, together with $621.2 proceeds from its January 2026 follow on public offering, are expected to fund operations into 2028.

Research and development expenses were $77.5 million for the fourth quarter of 2025, compared to $56.3 million for the fourth quarter of 2024. Research and development expenses were $267.1 million for the year ended December 31, 2025, compared to $152.4 million for the year ended December 31, 2024. The increase in research and development expenses for full year 2025 of $114.7 million was primarily attributable to an increase of $91.9 million in Praxis' Cerebrum(TM) platform, an increase of $15.3 million in personnel related costs and an increase of $5.0 million in Praxis' Solidus(TM) platform.

General and administrative expenses were $19.5 million for the fourth quarter of 2025, compared to $15.1 million for the fourth quarter of 2024. General and administrative expenses were $59.1 million for the year ended December 31, 2025, compared to $56.3 million for the year ended December 31, 2024. The increase in general and administrative expenses for full year 2025 of $2.8 million was primarily attributable to an increase in professional fees.

Praxis incurred a net loss of $88.9 million for the fourth quarter of 2025, including $9.9 million of stock-based compensation expense, compared to $58.7 million for the fourth quarter of 2024, including $8.6 million of stock-based compensation expense. Praxis reported a net loss of $303.3 million for the year ended December 31, 2025, including $33.9 million of stock-based compensation expense, compared to a net loss of $182.8 million for the year ended December 31, 2024, including $41.4 million of stock-based compensation expense.

As of December 31, 2025, Praxis had 25.2 million shares of common stock outstanding.

Conference Call

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February 19, 2026 07:30 ET (12:30 GMT)