---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-055287"
form_type: "8-K"
ticker: "VNDA"
cik: "0001347178"
company_name: "Vanda Pharmaceuticals Inc."
filed_at: "2025-03-17T23:59:59+00:00"
generated_at: "2026-05-24T15:19:20.806684+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Vanda announces FDA accepted tradipitant NDA for motion sickness; PDUFA Dec 30, 2025; firm criticizes timeline

## Summary
- FDA accepted for filing Vanda's NDA for tradipitant to treat motion sickness; PDUFA target date set for December 30, 2025.
- Vanda says FDA intends to take 12 months for review, 6 months beyond the statutory deadline, calling it a violation of the FD&C Act.
- Clinical data from pooled studies (681 subjects): vomiting in 14.6% (170 mg) and 18.9% (85 mg) vs 41.2% placebo, p<0.0001.
- Vanda publicly criticized the FDA as 'broken and unaccountable' for allegedly stifling innovation and delaying approval.

## SEC filing metadata
- accession: 0001193125-25-055287
- form_type: 8-K
- ticker: VNDA
- cik: 0001347178
- company_name: Vanda Pharmaceuticals Inc.
- filed_at: 2025-03-17T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1347178/000119312525055287/0001193125-25-055287-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1347178/000119312525055287/d938957d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-055287
- JSON: https://secwatch.observer/filing/0001193125-25-055287.json
- Plain text: https://secwatch.observer/filing/0001193125-25-055287.txt

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