Welcome to our dedicated page for Praxis Precision Medicines SEC filings (Ticker: PRAX), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Praxis Precision Medicines, Inc. (NASDAQ: PRAX) SEC filings page on Stock Titan provides access to the company’s regulatory disclosures as filed with the U.S. Securities and Exchange Commission. Praxis is a clinical-stage biopharmaceutical company focused on central nervous system (CNS) disorders, and its filings offer detailed insight into the development and financing of its precision neuroscience portfolio.
Through Forms 8-K, Praxis reports material events such as topline clinical results, regulatory interactions and capital markets transactions. Recent 8-K filings describe positive Phase 3 Essential3 data for ulixacaltamide in essential tremor, EMBOLD study outcomes for relutrigine in SCN2A- and SCN8A-related developmental and epileptic encephalopathies (DEEs), and RADIANT study data for vormatrigine in focal onset seizures and generalized epilepsy. Other 8-Ks outline pre-New Drug Application (NDA) meetings with the U.S. Food and Drug Administration (FDA), alignment on registrational pathways for elsunersen in early-onset SCN2A-DEE, and details of underwritten public offerings and at-the-market equity programs.
Investors can also use this page to monitor filings related to Praxis’ common stock listing on The Nasdaq Global Select Market under the symbol PRAX, shareholder meeting results, and executive compensation or governance matters disclosed in proxy-related documents. As Praxis advances ulixacaltamide, vormatrigine, relutrigine and elsunersen, its periodic and current reports are expected to discuss clinical progress, regulatory designations, risk factors and use of proceeds from financings.
Stock Titan enhances these filings with AI-powered summaries that highlight key points from lengthy documents, helping readers quickly understand the significance of each PRAX filing. Real-time updates from EDGAR, combined with accessible explanations of complex disclosures, make this page a practical starting point for analyzing Praxis Precision Medicines’ regulatory and financial reporting history.
Praxis Precision Medicines, Inc. reported that the U.S. Food and Drug Administration has accepted for review its New Drug Application for ulixacaltamide HCl to treat essential tremor in adults. The FDA set a target action date under the Prescription Drug User Fee Act of January 29, 2027 and indicated it is not planning to hold an advisory committee meeting.
Praxis Precision Medicines reported positive early clinical results and a key regulatory milestone in severe childhood epilepsies. In the EMBRAVE Part A Phase 1/2 trial, elsunersen produced a 77% placebo-adjusted seizure reduction from baseline and 57% of pediatric SCN2A DEE patients experienced at least a 28-day seizure-free period. All nine patients, aged 2–12 years, continued into an open-label extension where efficacy was sustained for up to one year, and all elsunersen-treated patients showed functional improvements such as better sleep, motor function, muscle tone, attention or neuropsychomotor development. Elsunersen was well-tolerated with no drug-related serious adverse events, no discontinuations and no neuroinflammation signals at doses up to 8 mg, and most treatment-emergent adverse events were mild to moderate. Separately, the FDA accepted for priority review the company’s New Drug Application for relutrigine for SCN2A and SCN8A developmental and epileptic encephalopathies, with a Prescription Drug User Fee Act target action date of September 27, 2026.
Praxis Precision Medicines Inc ownership filing: The Vanguard Group filed an amendment on 03/13/2026 reporting 0 shares beneficially owned and 0% of the common stock following an internal realignment. The filing states certain Vanguard subsidiaries will report ownership separately in reliance on SEC Release No. 34-39538.
Praxis Precision Medicines is a clinical-stage CNS-focused biopharmaceutical company using two platforms, Cerebrum™ (small molecules) and Solidus™ (ASOs), to develop precision therapies for neurological disorders driven by neuronal excitation–inhibition imbalance.
The company has four clinical-stage programs: ulixacaltamide for essential tremor with positive Phase 3 data and a submitted NDA; relutrigine for SCN2A- and SCN8A-related developmental and epileptic encephalopathies with a submitted NDA and ongoing broader Phase 3; vormatrigine for common epilepsies in the multi-study ENERGY program; and elsunersen, an ASO for SCN2A-DEE in the EMBRAVE and EMBRAVE3 studies.
Praxis highlights extensive patent coverage across its platforms, relies on CDMOs for manufacturing, and operates under standard FDA drug-development regulations. Key risks include ongoing operating losses, future capital needs, uncertain and lengthy regulatory pathways, clinical and enrollment risk, competitive pressure, heavy reliance on collaborators and licenses (including Ionis and RogCon), intellectual property challenges, cybersecurity threats, and significant stock-price volatility.
Praxis Precision Medicines reported a larger net loss for 2025 while advancing a late-stage CNS portfolio and significantly strengthening its balance sheet. The company posted a full-year net loss of $303.3 million, up from $182.8 million in 2024, driven mainly by higher research and development spending of $267.1 million as multiple programs advanced.
Cash, cash equivalents and marketable securities were $926.1 million as of December 31, 2025, compared to $469.5 million a year earlier, and together with $621.2 million in net proceeds from a January 2026 follow-on offering are expected to fund operations into 2028. The company submitted two NDAs to the FDA, for ulixacaltamide in essential tremor and relutrigine in SCN2A and SCN8A developmental and epileptic encephalopathies, and highlighted two additional late-stage programs, vormatrigine and elsunersen, with topline results expected in the first half of 2026.
Praxis Precision Medicines, Inc. received an amended Schedule 13G from investment entities affiliated with Point72 and Steven A. Cohen reporting beneficial ownership of 6.1% of its common stock as of December 31, 2025. The filing shows shared voting and dispositive power over 1,569,309 shares of common stock, including 511,030 shares issuable upon exercise of warrants and 500,000 shares issuable upon exercise of call options held by Point72 Associates. The reporting persons certify that the securities were not acquired for the purpose of changing or influencing control of Praxis Precision Medicines.
Perceptive Advisors LLC and affiliated reporting persons disclosed beneficial ownership of 1,995,986 shares of Praxis Precision Medicines, Inc. common stock, representing 7.2% of the class. The shares are held directly by Perceptive Life Sciences Master Fund, Ltd., with Perceptive Advisors as investment manager and Joseph Edelman as managing member.
The ownership percentage is based on 27,738,892 Praxis common shares outstanding as reported in a Prospectus Supplement filed under Rule 424(b)(5) on January 7, 2026. The reporting persons report shared voting and dispositive power over all 1,995,986 shares and certify the holdings are not for the purpose of changing or influencing control of Praxis.
Praxis Precision Medicines, Inc. received an ownership report from Orbis Investment Management Ltd and Allan Gray Australia Pty Ltd. Together, the reporting persons state they beneficially own 1,255,162 shares of Praxis common stock, representing 5% of the class as of 12/31/2025.
Orbis Investment Management Ltd reports sole voting and dispositive power over 1,252,573 shares, while Allan Gray Australia Pty Ltd reports sole voting and dispositive power over 2,589 shares. Both firms are non‑U.S. institutions equivalent to investment advisers and certify that the shares were acquired and are held in the ordinary course of business, not to change or influence control of Praxis.
Praxis Precision Medicines, Inc. received an amended Schedule 13G/A from Adage Capital Management, L.P., Robert Atchinson, and Phillip Gross reporting their beneficial ownership in the company’s common stock.
The Reporting Persons collectively hold 965,313 shares of common stock, representing 3.83% of the class, based on 25,195,092 shares outstanding as of December 31, 2025. All shares are held with shared voting and dispositive power and are reported as being acquired and held in the ordinary course of business, not for the purpose of changing or influencing control of Praxis.
Praxis Precision Medicines director Stuart A. Arbuckle reported new equity awards in the company. On February 6, 2026, he received 688 restricted stock units and 478 restricted stock units, each at a price of $0, with vesting tied to 2026 and 2027 service and the 2026 annual meeting. Each unit represents one share of common stock, settled only in shares. He was also granted a stock option for 224 shares at an exercise price of $319.57, vesting in monthly installments from February 26, 2026 until the earlier of June 26, 2026 or the 2026 annual meeting. Following these grants, he beneficially owns 1,166 shares of common stock and 224 stock options, all held directly.