---
schema_version: "secwatch.filing_event.v1"
accession: "0001689548-25-000100"
form_type: "8-K"
ticker: "PRAX"
cik: "0001689548"
company_name: "Praxis Precision Medicines, Inc."
filed_at: "2025-10-16T23:59:59+00:00"
generated_at: "2026-05-17T03:34:29.454732+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Praxis ulixacaltamide Essential3 Phase 3 meets primary endpoint: 4.3 pt mADL11 improvement vs placebo (p<0.0001)

## Summary
- Study 1: 4.3 pt mean improvement in mADL11 at Week 8 vs 1.7 pt placebo (p<0.0001); all key secondary endpoints significant.
- Study 2 randomized withdrawal: 55% maintained response on ulixacaltamide vs 33% placebo (p=0.037, OR=2.7).
- Common TEAEs included constipation, dizziness, euphoric mood, brain fog; no deaths or drug-related serious AEs.
- Pre-NDA meeting submitted to FDA; NDA submission planned by early 2026.
- Discontinuation rates due to TEAEs: 27% ulixacaltamide vs 1.7% placebo in Study 1.

## SEC filing metadata
- accession: 0001689548-25-000100
- form_type: 8-K
- ticker: PRAX
- cik: 0001689548
- company_name: Praxis Precision Medicines, Inc.
- filed_at: 2025-10-16T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1689548/000168954825000100/0001689548-25-000100-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1689548/000168954825000100/prax-20251016.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001689548-25-000100
- JSON: https://secwatch.observer/filing/0001689548-25-000100.json
- Plain text: https://secwatch.observer/filing/0001689548-25-000100.txt

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