---
schema_version: "secwatch.filing_event.v1"
accession: "0001689548-25-000118"
form_type: "8-K"
ticker: "PRAX"
cik: "0001689548"
company_name: "Praxis Precision Medicines, Inc."
filed_at: "2025-12-29T23:59:59+00:00"
generated_at: "2026-05-16T12:06:52.275193+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# PRAX gets FDA Breakthrough Therapy Designation for ulixacaltamide in essential tremor

## Summary
- Ulixacaltamide granted BTD for treatment of essential tremor based on Essential3 Phase 3 data.
- BTD enables expedited development and regulatory review for serious condition.
- Positive topline data from two pivotal Phase 3 studies supported the designation.
- Essential tremor affects millions; ulixacaltamide may show substantial improvement over available therapies.

## SEC filing metadata
- accession: 0001689548-25-000118
- form_type: 8-K
- ticker: PRAX
- cik: 0001689548
- company_name: Praxis Precision Medicines, Inc.
- filed_at: 2025-12-29T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1689548/000168954825000118/0001689548-25-000118-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1689548/000168954825000118/prax-20251229.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001689548-25-000118
- JSON: https://secwatch.observer/filing/0001689548-25-000118.json
- Plain text: https://secwatch.observer/filing/0001689548-25-000118.txt

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