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. 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.
Praxis Precision Medicines director Stuart A. Arbuckle reported equity compensation awards. He received 1,371 restricted stock units, each representing a contingent right to one share of common stock, vesting in a single installment on the earlier of June 10, 2027 or the company’s 2027 annual stockholder meeting. He was also granted options to purchase 648 shares of common stock at an exercise price of $240.66 per share, vesting in twelve equal monthly installments beginning July 10, 2026 and ending on the earlier of June 10, 2027 or the 2027 annual meeting. After these awards, he directly holds 2,537 common shares and 648 stock options, reflecting routine director compensation rather than open-market buying.
Praxis Precision Medicines director Jeffrey Chodakewitz received new equity awards as part of his compensation. He was granted 1,371 restricted stock units, each representing the right to receive one share of common stock, vesting in a single installment on the earlier of June 10, 2027 or the company’s 2027 annual stockholder meeting. He also received options for 648 shares at an exercise price of $240.66 per share, vesting in twelve equal monthly installments starting July 10, 2026 and expiring on June 10, 2036. These are awards from the company, not open-market purchases or sales.
Praxis Precision Medicines director William D. Young received new equity awards. On June 10, 2026, he was granted 1,371 restricted stock units, each representing one future share of common stock, vesting in a single installment on the earlier of June 10, 2027 or the 2027 annual stockholders meeting.
He was also granted a stock option for 648 shares of common stock at an exercise price of $240.6600 per share, vesting in twelve equal monthly installments beginning July 10, 2026 through the earlier of June 10, 2027 or the 2027 annual meeting. Following these awards, he directly owns 3,269 common shares and holds options for 648 shares.