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) on Jan 13, 2026 appointed Dr. Orrin Devinsky as Head of Clinical Strategy, a new leadership role reporting to Steven Petrou, Ph.D., President of Research and Development.
Dr. Devinsky brings more than 40 years of clinical experience, > 500 peer-reviewed publications, 16 issued patents, leadership on pivotal cannabidiol trials for rare epilepsies, and prior direction of a major academic epilepsy program. He will guide clinical program architecture, evidence generation, and global medical affairs as Praxis advances a late-stage portfolio toward commercialization.
Praxis Precision Medicines (NASDAQ: PRAX) outlined 2026 priorities after a pivotal 2025 that produced multiple late‑stage successes. The company expects two NDA submissions by mid‑February 2026 for ulixacaltamide (essential tremor) and relutrigine (SCN2A/8A DEEs), both with FDA Breakthrough Therapy Designation. Multiple pivotal readouts across vormatrigine, relutrigine and elsunersen are planned in 2026. Praxis reports a strong pro forma balance sheet of approximately $1.5 billion and completed a January 2026 public offering with net proceeds of ~$621 million. The company cites combined peak revenue potential for four late‑stage assets exceeding $20 billion.
Praxis Precision Medicines (Nasdaq: PRAX) announced that on January 2, 2026 its Compensation Committee granted restricted stock unit awards covering an aggregate of 434 shares to three new non-executive employees under the 2024 Inducement Plan.
The awards were granted as inducements material to the employees entering employment in accordance with Nasdaq Listing Rule 5635(c)(4). The 2024 Inducement Plan is used exclusively to grant equity awards to individuals who were not previously employees or who return after a bona fide period of non-employment. The restricted stock units vest in four equal annual installments, subject to continued employment on each vesting date.
Praxis Precision Medicines (NASDAQ: PRAX) announced board additions and senior executive promotions on January 8, 2026 to support a transition into late-stage development and commercial readiness. Jeffrey B. Kindler and Stuart Arbuckle joined the board to strengthen experience in global launches, strategic transactions, and commercial scaling. Megan Sniecinski was promoted to Chief Operating Officer to lead operational execution and corporate development, and Dr. Steven Petrou was promoted to President of Research & Development to oversee the full R&D continuum. The release highlights Praxis's late-stage pipeline and a successful ulixacaltamide Phase 3 program as the company prepares for potential registration and commercialization.
Praxis Precision Medicines (NASDAQ: PRAX) priced an underwritten public offering of 2,212,000 common shares at $260.00 per share, with gross proceeds of about $575 million before underwriting discounts and expenses. The company granted underwriters a 30‑day option to purchase up to 331,800 additional shares (15% overallotment). The offering is expected to close on or about January 8, 2026, subject to customary closing conditions and market conditions. The offering is being made from a shelf registration that became effective December 23, 2024; a preliminary prospectus supplement was filed January 6, 2026.
Praxis Precision Medicines (NASDAQ: PRAX) announced a proposed public offering of common stock and, for certain investors, pre-funded warrants. All securities will be offered by Praxis, with underwriters granted a 30-day option to buy additional shares up to 15% of the shares sold. The offering is subject to market and customary closing conditions and may not be completed.
The offering is being made under a shelf registration on Form S-3ASR that automatically became effective on Dec 23, 2024. Final terms will be disclosed in a prospectus supplement to be filed with the SEC.
Praxis Precision Medicines (NASDAQ: PRAX) announced the FDA has granted Breakthrough Therapy Designation (BTD) for ulixacaltamide HCl for treatment of essential tremor (ET), based on positive topline results from the Essential3 Phase 3 program.
The company completed a pre-NDA meeting with the FDA in December 2025, received written feedback and an in-person meeting, aligned on NDA content, and expects to submit the ulixacaltamide NDA in early 2026. The BTD enables expedited development and regulatory review but is not an approval.
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.
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