---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-062241"
form_type: "8-K"
ticker: "VNDA"
cik: "0001347178"
company_name: "Vanda Pharmaceuticals Inc."
filed_at: "2024-03-07T23:59:59+00:00"
generated_at: "2026-06-05T01:18:05.474905+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA issues Complete Response Letter for Vanda's HETLIOZ insomnia sNDA

## Summary
- Received CRL on March 4, 2024 for HETLIOZ (tasimelteon) to treat insomnia with sleep initiation difficulties.
- FDA stated deficiencies precluding approval; sNDA cannot be approved in present form.
- Vanda reviewing CRL and evaluating next steps; no specific financial impact disclosed.
- PDUFA date was March 4, 2024; FDA had flagged deficiencies on February 4, 2024.

## SEC filing metadata
- accession: 0001193125-24-062241
- form_type: 8-K
- ticker: VNDA
- cik: 0001347178
- company_name: Vanda Pharmaceuticals Inc.
- filed_at: 2024-03-07T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1347178/000119312524062241/0001193125-24-062241-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1347178/000119312524062241/d764198d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-062241
- JSON: https://secwatch.observer/filing/0001193125-24-062241.json
- Plain text: https://secwatch.observer/filing/0001193125-24-062241.txt

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