---
schema_version: "secwatch.filing_event.v1"
accession: "0001689548-26-000082"
form_type: "8-K"
ticker: "PRAX"
cik: "0001689548"
company_name: "Praxis Precision Medicines, Inc."
filed_at: "2026-08-06T12:31:27+00:00"
generated_at: "2026-08-06T12:35:16.714653+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Praxis Q2 net loss $83.7M; FDA mid-cycle positive for ulixacaltamide and relutrigine; no AdCom

## Summary
- FDA mid-cycle meetings for ulixacaltamide (ET) and relutrigine (DEEs) found no major safety/efficacy concerns; no advisory committee planned; PDUFA dates Jan 29, 2027 and Dec 27, 2026.
- BIMO inspections for both NDAs completed with no Form 483 observations.
- Third Breakthrough Therapy Designation granted for elsunersen in SCN2A DEE (gain-of-function).
- Q2 2026 net loss $83.7M; cash $1.4B, runway into 2028.
- Vormatrigine POWER1 missed primary endpoint but met secondary; plans to restart POWER2 and start POWER3 in Q4 2026.

## SEC filing metadata
- accession: 0001689548-26-000082
- form_type: 8-K
- ticker: PRAX
- cik: 0001689548
- company_name: Praxis Precision Medicines, Inc.
- filed_at: 2026-08-06T12:31:27+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 2.02, 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1689548/000168954826000082/0001689548-26-000082-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1689548/000168954826000082/prax-20260806.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001689548-26-000082
- JSON: https://secwatch.observer/filing/0001689548-26-000082.json
- Plain text: https://secwatch.observer/filing/0001689548-26-000082.txt

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