---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-086031"
form_type: "8-K"
ticker: "VNDA"
cik: "0001347178"
company_name: "Vanda Pharmaceuticals Inc."
filed_at: "2024-04-03T23:59:59+00:00"
generated_at: "2026-06-04T02:47:04.743392+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Vanda's Fanapt receives FDA approval for bipolar I disorder indication

## Summary
- FDA approved Fanapt (iloperidone) on April 2, 2024 for acute treatment of manic or mixed episodes in bipolar I disorder in adults.
- Approval based on pivotal study of ~400 patients; primary endpoint YMRS at Week 4 highly statistically significant (p=0.000008).
- Fanapt was previously approved for schizophrenia in 2009; safety profile consistent across indications.
- Vanda CEO cites significant increase in commercial opportunity; bipolar I disorder affects ~10M Americans.

## SEC filing metadata
- accession: 0001193125-24-086031
- form_type: 8-K
- ticker: VNDA
- cik: 0001347178
- company_name: Vanda Pharmaceuticals Inc.
- filed_at: 2024-04-03T23:59:59+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/1347178/000119312524086031/0001193125-24-086031-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1347178/000119312524086031/d819383d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-086031
- JSON: https://secwatch.observer/filing/0001193125-24-086031.json
- Plain text: https://secwatch.observer/filing/0001193125-24-086031.txt

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