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 second quarter 2026 results and regulatory progress for multiple CNS programs. The FDA completed mid‑cycle reviews for ulixacaltamide HCl in Essential Tremor and relutrigine in SCN2A/SCN8A DEEs, identifying no major safety or efficacy concerns to date and indicating no advisory committee meetings, with PDUFA dates on January 29, 2027 and December 27, 2026, respectively. FDA BIMO inspections for both NDAs concluded with no Form 483 observations.
Praxis reported $1.4 billion in cash and investments as of June 30, 2026, extending expected runway into 2028. Q2 2026 R&D expenses were $69.4 million, G&A expenses $27.5 million, and net loss $83.7 million. The company highlighted a third FDA Breakthrough Therapy Designation for elsunersen, EMERALD study enrollment of ~200 patients for relutrigine in broad DEEs, and plans to restart/expand vormatrigine epilepsy studies after POWER1’s mixed outcome.
Praxis Precision Medicines (Nasdaq: PRAX) reported that on August 3, 2026, its Board Compensation Committee granted restricted stock unit (RSU) awards covering an aggregate of 7,318 common shares to 29 new non-executive employees under the 2024 Inducement Plan. According to Praxis, these RSUs were approved as employment inducement grants in line with Nasdaq Listing Rule 5635(c)(4) and are reserved for individuals not previously employed by the company, or rehired after a bona fide break in service. The RSUs will vest in four equal annual installments, contingent on each employee’s continued employment with Praxis on the applicable vesting dates.
Praxis Precision Medicines (NASDAQ: PRAX) announced it will report financial results for the second quarter ended June 30, 2026, and provide a corporate update before markets open on Thursday, August 6, 2026.
The company will host a conference call and live webcast on August 6, 2026 at 8:30 a.m. ET to review the quarter and discuss corporate developments. Investors can access the live webcast via a registration link and through the Events & Presentations page in the Investors + Media section of www.praxismedicines.com. A replay of the second quarter earnings webcast will be available on the Events & Presentations page for approximately 90 days following the event.
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.