---
schema_version: "secwatch.filing_event.v1"
accession: "0001689548-26-000033"
form_type: "8-K"
ticker: "PRAX"
cik: "0001689548"
company_name: "Praxis Precision Medicines, Inc."
filed_at: "2026-04-14T23:59:59+00:00"
generated_at: "2026-05-15T06:23:59.979932+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Praxis Precision: FDA accepts NDA for ulixacaltamide in essential tremor; PDUFA Jan 29, 2027

## Summary
- FDA accepted NDA for ulixacaltamide HCl to treat essential tremor in adults; PDUFA target action date January 29, 2027.
- No advisory committee meeting will be held for the ulixacaltamide NDA review.
- The NDA seeks approval for a novel small-molecule therapy for a common movement disorder.

## SEC filing metadata
- accession: 0001689548-26-000033
- form_type: 8-K
- ticker: PRAX
- cik: 0001689548
- company_name: Praxis Precision Medicines, Inc.
- filed_at: 2026-04-14T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1689548/000168954826000033/0001689548-26-000033-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1689548/000168954826000033/prax-20260414.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001689548-26-000033
- JSON: https://secwatch.observer/filing/0001689548-26-000033.json
- Plain text: https://secwatch.observer/filing/0001689548-26-000033.txt

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