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) and Remagine Labs entered a research collaboration and license agreement to develop an iontophoretic transdermal patch for ulixacaltamide, in development for essential tremor (ET). Ulixacaltamide has FDA Breakthrough Therapy Designation, an accepted NDA, and a PDUFA target action date of January 29, 2027. Praxis also made an equity investment in Remagine Labs. The collaboration aims to add a programmable, multi-day transdermal option alongside the lead oral program, potentially broadening the ET patient population reached and extending the long-term value of the ulixacaltamide franchise in a large, underserved U.S. ET market.
Praxis Precision Medicines (Nasdaq: PRAX) reported that on July 1, 2026 its Compensation Committee granted restricted stock units covering 951 shares of common stock to five new non-executive employees under its 2024 Inducement Plan, with vesting in four equal annual installments, in line with Nasdaq Listing Rule 5635(c)(4).
Praxis Precision Medicines (NASDAQ: PRAX) reported that the FDA extended the review of its NDA for relutrigine, for treating SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs). The PDUFA target action date moved from September 27, 2026 to December 27, 2026 after a major amendment submission.
The extension follows additional sensitivity analyses of existing clinical data. No new clinical studies were requested, and the FDA cited no safety or manufacturing concerns. The review is active, and Praxis is preparing for potential relutrigine launch for DEE patients with high unmet need.
Praxis (NASDAQ: PRAX) received FDA Breakthrough Therapy Designation for elsunersen (PRAX-222) to treat seizures in SCN2A-DEE caused by gain-of-function variants. The designation is based on EMBRAVE Part A results showing a 77% sham-adjusted reduction in monthly seizures and sustained benefits up to one year.
The pivotal single-arm EMBRAVE3 registrational study is enrolling about 30 patients.
Praxis Precision Medicines (NASDAQ: PRAX) will present a corporate overview at the Goldman Sachs 47th Annual Global Healthcare Conference in Miami on Monday, June 8, 2026 at 8:00 a.m. ET. A live webcast and a replay (for ~180 days) will be available.
Praxis Precision Medicines (Nasdaq: PRAX) granted inducement restricted stock units on June 1, 2026, under its 2024 Inducement Plan. Awards cover an aggregate 2,754 shares of common stock for thirteen new non-executive employees and were approved under Nasdaq Listing Rule 5635(c)(4).
The RSUs vest in four equal annual installments, contingent on continued employment.
Praxis Precision Medicines (NASDAQ: PRAX) reported topline Phase 2/3 POWER1 results for vormatrigine in focal onset seizures. The primary endpoint, percent change in monthly seizure frequency, was not met. A key secondary endpoint, 50% responder rate, was achieved, with more pronounced seizure reduction at 30 mg in the study’s second half.
Vormatrigine was generally well-tolerated, with adverse event-related discontinuations under 10%, and about 90% of treated patients entered and remain in the open-label extension. Praxis is pausing enrollment in POWER2 while reassessing the vormatrigine program and continues preparing planned launches for relutrigine and ulixacaltamide.
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.