Welcome to our dedicated page for Praxis Precision Medicines news (Ticker: PRAX), a resource for investors and traders seeking the latest updates and insights on Praxis Precision Medicines stock.
Praxis Precision Medicines, Inc. (NASDAQ: PRAX) is a clinical-stage biopharmaceutical company focused on central nervous system (CNS) disorders characterized by neuronal excitation–inhibition imbalance. The PRAX news page on Stock Titan aggregates company announcements, clinical updates, regulatory milestones and capital markets activity related to its precision neuroscience pipeline.
Investors and followers of Praxis can use this page to track developments across the company’s diversified CNS portfolio. News items include progress updates on late-stage product candidates such as ulixacaltamide for essential tremor, vormatrigine for focal onset seizures and generalized epilepsy, relutrigine for developmental and epileptic encephalopathies (DEEs), and elsunersen for early-onset SCN2A-DEE. Praxis frequently reports on Phase 2 and Phase 3 study readouts, FDA interactions such as pre-NDA meetings and Breakthrough Therapy Designations, and changes to registrational trial designs.
The feed also covers corporate and financial disclosures, including underwritten public offerings, at-the-market equity programs, and governance or leadership changes. Form 8-K filings referenced in press releases provide additional detail on clinical data, regulatory feedback and financing terms. Because Praxis emphasizes precision neuroscience and genetic epilepsies, its news often highlights mechanistic data, biomarker findings and functional outcomes in epilepsy and movement disorder studies.
By reviewing this PRAX news stream, readers can follow key catalysts such as NDA preparation, pivotal trial milestones, regulatory designations and capital raises that may influence the company’s trajectory as it advances its CNS portfolio. Bookmark this page to access an organized view of Praxis Precision Medicines’ latest public communications and disclosures.
Praxis Precision Medicines (NASDAQ: PRAX) announced that following a planned discussion with the FDA on Dec 11, 2025, the agency confirmed the company may file a New Drug Application (NDA) for relutrigine in early 2026 for SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs). The company said EMBOLD study data will serve as the basis for efficacy and safety, and described EMBOLD results as statistically significant and clinically meaningful improvements. Management characterized the FDA interaction as collaborative and supportive of the planned NDA timeline.
Praxis Precision Medicines (NASDAQ: PRAX) announced FDA alignment to convert the EMBRAVE3 registrational study of elsunersen in early-onset SCN2A developmental and epileptic encephalopathy to a single-arm, baseline-controlled design.
Key changes: enrollment target reduced to 30 patients from 40, all screening patients will receive elsunersen for 24 weeks then enter an open-label extension, and the primary endpoint is change from baseline in countable motor seizures. Enrollment is accelerating and topline results are expected in 2026; EMBRAVE Part A (n=9) topline readout is expected in 1H 2026.
Praxis (NASDAQ: PRAX) reported clinical updates presented at AES on December 6, 2025, covering relutrigine (EMBOLD) and vormatrigine (RADIANT).
EMBOLD: relutrigine (n=51) produced a 53% placebo‑adjusted seizure reduction over 16 weeks (p<0.0002), a 66% increase in motor seizure‑free days (p=0.034), broad functional improvements, and no drug‑related serious adverse events; Praxis will meet the FDA to discuss an NDA and then decide filing timing.
RADIANT: vormatrigine (FOS n=62) delivered a 54% median seizure reduction at 8 weeks, 58% ≥50% responders in week 1 rising to 61% by week 8, with 100% median weekly seizure reduction by week 8 maintained to 16 weeks; generalized epilepsy cohort (n=3) showed similar effects. POWER1 recruiting complete; POWER2 on track to finish H2 2026; POWER3 monotherapy to start H1 2026.
Praxis Precision Medicines (NASDAQ: PRAX) announced positive topline results from the registrational cohort of the EMBOLD study evaluating relutrigine in SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs).
A Data Monitoring Committee recommended an early stop for efficacy. Praxis will present topline results at the American Epilepsy Society Annual Meeting on December 6, 2025 and has a confirmed meeting with the FDA to review the data and discuss next steps; the company will decide on NDA timing after that meeting.
Praxis Precision Medicines (NASDAQ: PRAX) completed a pre-NDA meeting with the FDA for ulixacaltamide in essential tremor and received written feedback plus an in-person discussion. The company said it gained alignment with the agency on NDA content and expects to submit the NDA in early 2026. Praxis highlighted momentum from the positive Essential3 program, where ulixacaltamide showed statistically significant, clinically meaningful improvements in daily functioning. Management framed the FDA feedback as advancing the program toward a potential new treatment for millions living with essential tremor.
Praxis Precision Medicines (Nasdaq: PRAX) announced on Dec 1, 2025 that its Compensation Committee granted restricted stock unit awards covering 3,594 shares to six new non-executive employees under the 2024 Inducement Plan in accordance with Nasdaq Listing Rule 5635(c)(4).
The awards were issued as inducements material to the employees joining Praxis and will vest in four equal annual installments, subject to continued employment on each vesting date. The 2024 Inducement Plan is limited to equity awards for individuals not previously employed by Praxis or returning after a bona fide break in service.
Praxis Precision Medicines (NASDAQ: PRAX) will present new preclinical and clinical data across its precision epilepsy portfolio at the American Epilepsy Society Annual Meeting, Dec 5–9, 2025 in Atlanta.
Praxis will host a scientific exhibit and booth #217, and deliver multiple poster and late-breaking presentations including full RADIANT results showing vormatrigine seizure reductions, EMBOLD OLE relutrigine data, PAC-DEE preclinical framework updates, antisense oligonucleotide emergency use cases for SCN2A DEE, and DDI and preclinical findings across programs.
Praxis Precision Medicines (NASDAQ: PRAX) announced an expert fireside chat on November 24, 2025 at 1:00 PM EST to discuss a deep dive into clinical data for ulixacaltamide. The event will be hosted by HC Wainwright analyst Doug Tsao and feature UCSF statistician Prof. Chuck McCullough alongside Praxis CEO Marcio Souza. The session focuses on interpretation of ulixacaltamide clinical results and will include an analyst-led discussion; registration is available via the company’s provided link.
Praxis Precision Medicines (Nasdaq: PRAX) announced on November 6, 2025 that its Compensation Committee granted restricted stock unit awards covering 6,876 shares to six new non-executive employees under the 2024 Inducement Plan.
The awards were granted on November 3, 2025 as inducements under Nasdaq Listing Rule 5635(c)(4) and will vest in four equal annual installments, subject to continued employment on each vesting date. The 2024 Inducement Plan is used exclusively for equity awards to individuals who were not previously employees or who return after a bona fide non-employment period.
Praxis Precision Medicines (NASDAQ: PRAX) will attend and present at multiple investor conferences in November 2025, including corporate presentations and a fireside chat.
Scheduled events:
- Truist Securities BioPharma Symposium — Nov 6, 2025 at 10:40am ET, Lotte New York Palace Hotel, New York City.
- HC Wainwright Emerging Ideas on BioPharma — Nov 7, 2025 at 12:30pm ET, fireside chat with analyst Doug Tsao (registration available).
- Guggenheim Securities Healthcare Innovation Conference — Nov 10, 2025 at 9:30am ET, InterContinental Boston; live webcast available.
- Jefferies Global Healthcare Conference — Nov 18, 2025 at 1:30pm GMT, Waldorf Hilton London; live webcast available.
Replays of the third quarter earnings webinar and conference webcasts will be posted on Praxis’ Events and Presentations page for approximately 90 days after each event.