---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-25-054225"
form_type: "8-K"
ticker: "VNDA"
cik: "0001347178"
company_name: "Vanda Pharmaceuticals Inc."
filed_at: "2025-11-28T23:59:59+00:00"
generated_at: "2026-05-16T16:02:51.269013+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# FDA extends parcial clinical hold re-review to Dec 5; PDUFA date remains Dec 30 for tradipitant

## Summary
- FDA and Vanda agreed to extend partial clinical hold re-review target to Dec 5, 2025 (from Nov 26) due to CDER personnel transitions.
- PDUFA action date for tradipitant NDA for motion sickness vomiting prevention unchanged at December 30, 2025.
- FDA issued labeling comments; labeling discussions with Vanda have formally commenced.
- Vanda aims to deliver first new pharmacologic treatment for motion sickness in over 40 years.

## SEC filing metadata
- accession: 0001628280-25-054225
- form_type: 8-K
- ticker: VNDA
- cik: 0001347178
- company_name: Vanda Pharmaceuticals Inc.
- filed_at: 2025-11-28T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1347178/000162828025054225/0001628280-25-054225-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1347178/000162828025054225/vnda-20251128.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-25-054225
- JSON: https://secwatch.observer/filing/0001628280-25-054225.json
- Plain text: https://secwatch.observer/filing/0001628280-25-054225.txt

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