Praxis Precision Medicines Files 8-K

TL;DR

Praxis Precision Medicines filed an 8-K on Dec 8 for an event on Dec 4. No details yet.

AI Summary

Praxis Precision Medicines, Inc. filed an 8-K on December 8, 2025, reporting an event that occurred on December 4, 2025. The filing is categorized under 'Other Events' and does not appear to involve any specific financial transactions or material agreements based on the provided text.

Why It Matters

This filing indicates a corporate event has been reported by Praxis Precision Medicines, Inc. to the SEC, requiring disclosure to investors.

Risk Assessment

Risk Level: low — The filing is a standard 8-K for 'Other Events' and does not disclose specific material information that would immediately impact risk.

Key Players & Entities

• Praxis Precision Medicines, Inc. (company) — Registrant
• December 4, 2025 (date) — Earliest event reported
• December 8, 2025 (date) — Date of report
• 0001689548-25-000114 (accession_number) — Filing accession number

FAQ

Key Financial Figures

• $0.0001 — ge on which registered Common Stock, $0.0001 par value per share PRAX The Nasdaq Glo

Filing Documents

• prax-20251204.htm (8-K) — 37KB
• 0001689548-25-000114.txt ( ) — 154KB
• prax-20251204.xsd (EX-101.SCH) — 2KB
• prax-20251204_lab.xml (EX-101.LAB) — 22KB
• prax-20251204_pre.xml (EX-101.PRE) — 13KB
• prax-20251204_htm.xml (XML) — 3KB

01. Other Events

Item 8.01. Other Events. Ulixacaltamide On December 4, 2025, Praxis Precision Medicines, Inc. (the "Company") announced the successful completion of its pre-New Drug Application ("NDA") meeting with the U.S. Food and Drug Administration (the "FDA"), including receipt of written feedback and an in-person meeting. The Company has gained alignment from the FDA on the content of the NDA and expects to complete its NDA submission in early 2026. Relutrigine On December 4, 2025, the Company announced positive results from the registrational cohort of the EMBOLD study evaluating relutrigine for the treatment of patients with SCN2A and SCN8A developmental and epileptic encephalopathies ("DEEs"), following a recommendation by the Data Monitoring Committee to stop the study early for efficacy. On December 6, 2025, the Company shared the results of the EMBOLD study, demonstrating relutrigine was well-tolerated with rapid, significant and increasing seizure reduction over time with broad functional improvements across behavior, alertness, communication and overall status. The Company will meet with the FDA in the coming weeks to discuss next steps. The Company will make a determination of the timing for filing the NDA after the meeting. The topline results for the EMBOLD study were as follows: Patients receiving relutrigine (n=51) experienced a 53% placebo-adjusted reduction in seizures over 16-weeks (p<0.0002). Patients achieved a 66% increase in motor seizure-free days (p=0.034). Both clinician and caregiver global impression scores showed statistically significant improvements, with most patients improving across both scales in alertness, communication, and seizure severity. There were no drug-related serious adverse events and treatment-related adverse events were predominantly mild and moderate. Vormatrigine On December 6, 2025, the Company shared the full results of the RADIANT study evaluating vormatrigine in patients with focal onset seizures ("FOS") or gener

Forward-Looking Statements

Forward-Looking Statements This Current Report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the clinical development of relutrigine and vormatrigine and the anticipated timing of regulatory submissions and interactions for ulixacaltamide and relutrigine. The forward-looking statements included in this Current Report are subject to a number of risks, uncertainties and assumptions, including, without limitation, uncertainties inherent in clinical trials, the expected timing of submission for regulatory approval or review by governmental authorities and other risks as described in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, its Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 and its other filings with the Securities and Exchange Commission. These statements are based only on facts currently known by the Company and speak only as of the date of this Current Report. As a result, you are cautioned not to rely on these forward-looking statements and the Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise. SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. PRAXIS PRECISION MEDICINES, INC. Date: December 8, 2025 By: /s/ Marcio Souza Marcio Souza Chief Executive Officer

View Full Filing

View this 8-K filing on SEC EDGAR