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.
Praxis Precision Medicines filings document regulatory disclosures for a CNS-focused biopharmaceutical issuer with common stock listed on the Nasdaq Global Select Market under PRAX. Its Form 8-K and 8-K/A reports cover material events, operating and financial results, clinical and regulatory updates, capital-structure disclosures, and leadership or board changes.
The company’s filing record includes disclosures related to ulixacaltamide HCl for essential tremor, elsunersen in SCN2A developmental and epileptic encephalopathy, and broader pipeline programs in movement disorders and epilepsy. Proxy materials address annual meeting matters, board composition, committee assignments, executive compensation, equity awards and other governance subjects.
PRAXIS PRECISION MEDICINES INC. ownership disclosure: FMR LLC reports beneficial ownership of 2,156,343.22 shares of common stock, representing 7.7% of the class as of 03/31/2026. The filing states these shares are held on behalf of others and that no single other person holds more than 5% of the class.
Praxis Precision Medicines, Inc. is soliciting proxies for its 2026 virtual annual meeting on June 10, 2026. Stockholders will vote on electing three Class III directors to terms ending at the 2029 meeting, ratifying Ernst & Young LLP as auditor for 2026, and approving an advisory Say‑on‑Pay resolution on executive compensation.
The record date is April 15, 2026, when 27,872,305 common shares were outstanding. The proxy describes a staggered nine‑member board, committee structure, and pay‑for‑performance program where most senior executive compensation is at risk and heavily equity‑based, reflecting significant 2025 clinical, regulatory and capital‑raising milestones.
Praxis Precision Medicines Inc ownership filing shows 1,419,323 shares of Common Stock reported by Vanguard Capital Management, representing 5.09% of the class. The filing lists 197,379 shares as sole voting power and 1,419,323 as sole dispositive power. The filing notes that this ownership "reflects the securities beneficially owned, or deemed to be beneficially owned, by Vanguard Capital Management LLC and the following affiliates..."
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.