---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-26-010376"
form_type: "8-K"
ticker: "VNDA"
cik: "0001347178"
company_name: "Vanda Pharmaceuticals Inc."
filed_at: "2026-02-23T23:59:59+00:00"
generated_at: "2026-05-16T01:05:44.320965+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Vanda Pharmaceuticals receives FDA approval for Bysanti (milsaperidone) for bipolar I disorder and schizophrenia

## Summary
- Bysanti (milsaperidone) approved for acute manic/mixed episodes of bipolar I disorder and schizophrenia in adults.
- Bysanti is a new chemical entity that interconverts to iloperidone, leveraging 100,000+ patient-years of real-world experience.
- Vanda expects commercial availability in Q3 2026; marketing exclusivity protected by patents expiring in 2044.
- This is Vanda's second new drug approval in less than 2 months, following NEREUS in December 2025.
- Bysanti is being tested as a once-daily adjunctive for treatment-resistant major depressive disorder, study completion expected by end of 2026.

## SEC filing metadata
- accession: 0001628280-26-010376
- form_type: 8-K
- ticker: VNDA
- cik: 0001347178
- company_name: Vanda Pharmaceuticals Inc.
- filed_at: 2026-02-23T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1347178/000162828026010376/0001628280-26-010376-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1347178/000162828026010376/vnda-20260220.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-26-010376
- JSON: https://secwatch.observer/filing/0001628280-26-010376.json
- Plain text: https://secwatch.observer/filing/0001628280-26-010376.txt

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