---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-25-055393"
form_type: "8-K"
ticker: "VNDA"
cik: "0001347178"
company_name: "Vanda Pharmaceuticals Inc."
filed_at: "2025-12-04T23:59:59+00:00"
generated_at: "2026-05-16T14:34:11.200357+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# FDA lifts partial clinical hold on Vanda's tradipitant for motion sickness

## Summary
- FDA lifted partial clinical hold on protocol VP-VLY-686-3403, removing the 90-dose cap on tradipitant studies.
- Lift followed Vanda's formal dispute resolution and expedited re-review under October 2025 collaborative framework.
- FDA agreed motion sickness is acute, event-driven; no additional dog toxicity study required.
- NDA for tradipitant to prevent vomiting due to motion remains under review; PDUFA date December 30, 2025.
- CEO Mihael Polymeropoulos thanked FDA for swift scientific review and constructive dialogue.

## SEC filing metadata
- accession: 0001628280-25-055393
- form_type: 8-K
- ticker: VNDA
- cik: 0001347178
- company_name: Vanda Pharmaceuticals Inc.
- filed_at: 2025-12-04T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1347178/000162828025055393/0001628280-25-055393-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1347178/000162828025055393/vnda-20251204.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-25-055393
- JSON: https://secwatch.observer/filing/0001628280-25-055393.json
- Plain text: https://secwatch.observer/filing/0001628280-25-055393.txt

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