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. is reported as having 1,529,788 shares of its common stock beneficially owned by Orbis Investment Management Ltd and Allan Gray Australia Pty Ltd, representing 5.5% of the class as of June 30, 2026. Orbis holds 1,526,680 shares with sole voting and dispositive power, and Allan Gray Australia holds 3,108 shares with sole voting and dispositive power. The two firms file together as non-U.S. institutions equivalent to investment advisers but each disclaims beneficial ownership of shares attributed to the other, and note that other persons have rights to dividends or sale proceeds for the shares they manage.
Praxis Precision Medicines, a CNS-focused biopharmaceutical company, reported a Q2 2026 net loss of $83.7 million and a first-half loss of $176.3 million, driven by research and development expense of $69.4 million and general and administrative expense of $27.5 million. Higher costs reflected expanded clinical programs and commercial preparation.
Cash, cash equivalents and marketable securities totaled $1.4 billion as of June 30, 2026, and management expects this to fund operating and capital needs into 2028. The company remains pre-revenue and continues to invest heavily in its pipeline.
Pipeline progress is significant. NDAs for ulixacaltamide in essential tremor and relutrigine in SCN2A/SCN8A developmental and epileptic encephalopathies are under FDA review, with PDUFA action dates on December 27, 2026 and January 29, 2027, and no major safety or efficacy concerns identified to date. Elsunersen received FDA breakthrough therapy designation for SCN2A gain-of-function DEE and is in a Phase 3 registrational trial. One vormatrigine study in focal onset seizures missed its primary endpoint, leading to a temporary pause in another study while the program is reassessed. Praxis also regained full global rights to its KCNT1 program after its collaboration with UCB ended with no termination payments.
Praxis Precision Medicines reported second-quarter 2026 results and a broad CNS pipeline update. Cash, cash equivalents and marketable securities were $1.4 billion as of June 30, 2026, up from $926.1 million at year-end 2025, extending expected funding runway into 2028. The quarter’s net loss was $83.7 million versus $71.1 million a year earlier, driven by higher R&D spending of $69.4 million and G&A of $27.5 million.
Two NDAs are under FDA review: ulixacaltamide for Essential Tremor with a PDUFA date of January 29, 2027, and relutrigine for SCN2A/SCN8A developmental and epileptic encephalopathies with a PDUFA date of December 27, 2026. Mid‑cycle meetings for both identified no major safety or efficacy concerns and no advisory committee meetings are planned; FDA Bioresearch Monitoring inspections concluded with no Form 483 observations. Elsunersen for early‑onset SCN2A DEE received a Breakthrough Therapy Designation after positive EMBRAVE Part A data, with the pivotal EMBRAVE3 trial enrolling and topline results expected in 2027. Vormatrigine’s POWER1 study in focal onset seizures did not meet its primary endpoint but showed a ≥50% responder signal, and Praxis plans to restart POWER2 and initiate POWER3 in the fourth quarter of 2026.
Praxis Precision Medicines, Inc. Chief Executive Officer Marcio Souza reported gifting a total of 23,121 shares of Praxis common stock. The transactions are coded as bona fide gifts, meaning they were transfers without payment rather than market sales.
The filing shows 2,600 shares previously held indirectly through his spouse were gifted to the Souza 2026 Trust, reducing that indirect position to zero. An additional 20,521 directly held shares were also gifted, leaving Souza with 56,495 Praxis shares held directly after the transactions.
Praxis Precision Medicines entered a research collaboration and license agreement with Remagine Labs to develop an iontophoretic transdermal patch to deliver ulixacaltamide for essential tremor. The patch will use Remagine’s electronically controlled, multi-day dosing platform to complement Praxis’s lead oral ulixacaltamide program.
The goal of adding a transdermal option is to broaden the patient population ulixacaltamide can reach and support its competitive positioning and long-term franchise value. Praxis also made an equity investment in Remagine, reinforcing their commitment to advance this delivery approach alongside ongoing clinical development.
Praxis Precision Medicines, Inc. reported that its Audit Committee dismissed Ernst & Young LLP as independent registered public accounting firm and engaged KPMG LLP, both effective June 29, 2026. EY’s audit reports on the company’s 2024 and 2025 financial statements contained no adverse opinions or disclaimers.
The company states there were no disagreements with EY on accounting principles, financial disclosures, or audit procedures, and no reportable events during those periods. Praxis also reports that it did not consult KPMG on accounting principles, potential audit opinions, or any matters involving disagreements or reportable events before the appointment.
Praxis Precision Medicines reported that the FDA has extended by three months the review period for its New Drug Application for relutrigine, a treatment for SCN2A and SCN8A developmental and epileptic encephalopathies. The PDUFA target action date moved from September 27, 2026 to December 27, 2026.
The extension follows Praxis’s submission of additional sensitivity analyses of existing clinical data, which the FDA classified as a “major amendment,” requiring more review time. The agency did not request new clinical studies and did not raise safety or manufacturing concerns, and the review remains active. Praxis states it continues preparing for a potential relutrigine launch and remains confident in the strength of its application.
Praxis Precision Medicines director Jill DeSimone reported a series of option-related trades in the company’s common stock. On June 24, 2026, she exercised options for a total of 11,600 shares at exercise prices of $44.25 and $147.30 per share, then sold 11,600 shares in multiple open-market transactions at weighted-average prices in the low $300s under a pre-arranged Rule 10b5-1 trading plan. After these transactions, she directly holds 2,337 Praxis common shares.
Praxis Precision Medicines reported that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for elsunersen (PRAX-222), an antisense oligonucleotide being developed to treat seizures associated with SCN2A developmental and epileptic encephalopathy caused by gain-of-function SCN2A variants.
This designation is intended to enable expedited development and regulatory review for therapies that treat serious conditions and show preliminary clinical evidence of substantial improvement over existing treatments. The decision was supported by positive topline results from the EMBRAVE Part A trial, a randomized, sham-controlled Phase 1/2 study in nine pediatric patients aged 2–12 years with early-seizure-onset SCN2A-DEE.