Vanda Pharmaceuticals Inc.
HETLIOZ
jet lag disorder
Resolved
181days ago
FDA decision Β· Jan 7, 2026
What's at stake
An FDA complete response letter on HETLIOZ for jet lag disorder is in focus around Jan 7, 2026.
Primary source
Β· SEC 8-K
verified 13h ago
βOn January 7, 2026, Vanda received a letter from the FDA stating that, following this re-review, it had concluded that the sNDA cannot be approved in its current form.β