---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-25-043489"
form_type: "8-K"
ticker: "VNDA"
cik: "0001347178"
company_name: "Vanda Pharmaceuticals Inc."
filed_at: "2025-10-01T23:59:59+00:00"
generated_at: "2026-05-17T05:03:22.879542+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Vanda reaches FDA framework to resolve disputes on HETLIOZ and tradipitant

## Summary
- FDA expedited re-review of tradipitant clinical hold by Nov 26, 2025; PDUFA date Dec 30, 2025.
- FDA expedited re-review of HETLIOZ sNDA for jet lag by Jan 7, 2026; Part 12 proceedings paused.
- Vanda dismisses two lawsuits: one on tradipitant clinical hold (M.D. Fla.) and one on HETLIOZ info (S.D. Tex.).
- Both parties seek temporary pause of tradipitant gastroparesis administrative proceedings until Jan 7, 2026.

## SEC filing metadata
- accession: 0001628280-25-043489
- form_type: 8-K
- ticker: VNDA
- cik: 0001347178
- company_name: Vanda Pharmaceuticals Inc.
- filed_at: 2025-10-01T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1347178/000162828025043489/0001628280-25-043489-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1347178/000162828025043489/vnda-20251001.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-25-043489
- JSON: https://secwatch.observer/filing/0001628280-25-043489.json
- Plain text: https://secwatch.observer/filing/0001628280-25-043489.txt

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