---
schema_version: "secwatch.filing_event.v1"
accession: "0001689548-23-000133"
form_type: "8-K"
ticker: "PRAX"
cik: "0001689548"
company_name: "Praxis Precision Medicines, Inc."
filed_at: "2023-10-02T23:59:59+00:00"
generated_at: "2026-06-10T06:23:48.322552+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Praxis Precision updates clinical pipeline at R&D Day; ulixacaltamide NDA plan 2025

## Summary
- Ulixacaltamide: 55% vs 31% patients achieved ≥3-point mADL11 improvement (p=0.023) in Essential1.
- FDA confirmed mADL11 as primary endpoint for Phase 3 Essential3; NDA submission expected in 2025.
- PRAX-222 EMBRAVE Part 1 dosing nearly complete; no treatment-related SAEs; 44% median seizure reduction.
- PRAX-628 Phase 1 data show sustained brain activity; Phase 2 PPR study results expected Q4 2023.
- PRAX-562 EMBOLD study ongoing; topline results from pediatric epilepsy study expected H1 2024.

## SEC filing metadata
- accession: 0001689548-23-000133
- form_type: 8-K
- ticker: PRAX
- cik: 0001689548
- company_name: Praxis Precision Medicines, Inc.
- filed_at: 2023-10-02T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1689548/000168954823000133/0001689548-23-000133-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1689548/000168954823000133/prax-20231002.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001689548-23-000133
- JSON: https://secwatch.observer/filing/0001689548-23-000133.json
- Plain text: https://secwatch.observer/filing/0001689548-23-000133.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.