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 reports developments for a central nervous system precision neuroscience biopharmaceutical company focused on therapies for disorders involving neuronal excitation-inhibition imbalance. Its recurring updates cover the Cerebrum small molecule platform, the Solidus antisense oligonucleotide platform, and product candidates across movement disorders and epilepsy, including ulixacaltamide, relutrigine, vormatrigine and elsunersen.
Company news commonly addresses FDA review activity, clinical trial data, scientific presentations, operating and financial results, commercial-readiness updates, equity inducement grants under Nasdaq rules and governance matters. Disease areas highlighted in its disclosures include essential tremor and developmental and epileptic encephalopathies associated with SCN2A and SCN8A.
Praxis Precision Medicines (NASDAQ: PRAX) reported Q1 2026 results and a corporate update. Key clinical and regulatory milestones include FDA acceptance of NDAs for ulixacaltamide in Essential Tremor (PDUFA Jan 29, 2027) and relutrigine in SCN2A/SCN8A DEEs (priority review, PDUFA Sep 27, 2026). EMBRAVE Part A showed a 77% placebo-adjusted reduction in monthly seizures for elsunersen. POWER1 topline for vormatrigine expected Q2 2026. Cash and investments were approximately $1.4 billion as of March 31, 2026, funding operations into 2028.
Praxis Precision Medicines (Nasdaq: PRAX) granted restricted stock units covering 5,420 shares on May 1, 2026 to 21 new non-executive employees under its 2024 Inducement Plan. Awards were made as inducements under Nasdaq Listing Rule 5635(c)(4).
The restricted stock units vest in four equal annual installments, subject to continued employment on each vesting date.
Praxis Precision Medicines (NASDAQ: PRAX) will report first quarter 2026 financial results and provide a corporate update before markets open on Thursday, May 7, 2026 at 8:30 am ET. The company will host a conference call and live webcast; registration and replay links are available on the investor website.
Praxis will also present at the Bank of America Securities Health Care Conference on Tuesday, May 12, 2026 at 7:20 pm EDT, with a live webcast and a replay available for approximately 90 days.
Praxis Precision Medicines (NASDAQ: PRAX) said the FDA accepted its New Drug Application for ulixacaltamide HCl to treat essential tremor in adults and set a PDUFA target action date of January 29, 2027. No advisory committee meeting is expected.
The NDA is supported by positive Essential3 Phase 3 results and notes a consistent safety profile; ulixacaltamide received Breakthrough Therapy Designation in December 2025.
Praxis (NASDAQ: PRAX) will present expanded Phase 3 Essential3 data for ulixacaltamide at AAN 2026, including a plenary on maintenance of response and topline randomized withdrawal results. Ulixacaltamide has received FDA Breakthrough Therapy Designation; Praxis will present 15 scientific posters and oral sessions April 18–22, 2026.
Praxis Precision Medicines (NASDAQ: PRAX) reported positive topline EMBRAVE Part A results for elsunersen in pediatric SCN2A early-onset developmental and epileptic encephalopathy (DEE). Elsunersen showed a 77% placebo-adjusted seizure reduction from baseline (p=0.015) and sustained benefit in an open-label extension for up to one year.
Additional findings: 57% of patients had a ≥28-day seizure-free period; 100% of treated patients had improvements in sleep, motor function, muscle tone or attention; no drug-related serious adverse events were reported. Nine patients were randomized 3:1; dosing started at 1 mg with escalation to 8 mg.
Praxis Precision Medicines (Nasdaq: PRAX) announced on April 1, 2026 that its Compensation Committee granted restricted stock unit awards covering an aggregate of 3,558 shares to eighteen new non-executive employees under the 2024 Inducement Plan.
The awards were granted as inducements under Nasdaq Listing Rule 5635(c)(4) and vest in four equal annual installments, subject to continued employment on each vesting date.
Praxis Precision Medicines (NASDAQ: PRAX) said the FDA accepted its New Drug Application for relutrigine and granted priority review, assigning a PDUFA target action date of September 27, 2026.
The NDA is supported by the EMBOLD study, which stopped early for efficacy, and relutrigine holds Orphan Drug, Rare Pediatric Disease, and Breakthrough Therapy designations. If approved, relutrigine would be the first FDA-approved therapy for SCN2A and SCN8A developmental and epileptic encephalopathies and eligible for a Pediatric Review Voucher. The EMERALD trial is expected to complete by the end of 2026.
Praxis Precision Medicines (Nasdaq: PRAX) announced on March 4, 2026 that its Compensation Committee granted restricted stock unit awards covering 2,931 shares to fourteen new non-executive employees under the 2024 Inducement Plan.
The awards were granted on March 2, 2026 as inducements under Nasdaq Listing Rule 5635(c)(4) and vest in four equal annual installments, subject to continued employment on each vesting date.
Praxis Precision Medicines (NASDAQ: PRAX) reported Q4 and full-year 2025 results and provided a corporate update. Key developments include two NDA submissions for ulixacaltamide (essential tremor) and relutrigine (SCN2A/SCN8A DEEs), Breakthrough Therapy designations, and multiple 2026 topline readouts.
Financials: $926.1M cash at 12/31/2025, $621.2M net proceeds in Jan 2026, and funding expected into 2028; 2025 net loss $303.3M and R&D $267.1M.