According to Vanda, the FDA has not granted such a hearing in the context of drug approvals for potentially over 40 years.
- Hetlioz is currently approved in the U.S. for the treatment of sleep disturbances associated with Smith-Magenis syndrome.
- However, the FDA has rejected Vanda's application for a jet lag indication multiple times, most recently in January 2026.
- On March 2, 2026, the FDA granted Vanda a formal evidentiary public hearing to review the proposed refusal.
Vanda Pharmaceuticals Inc. (VNDA) on Tuesday said that there will be a formal evidentiary public hearing to review the Center for Drug Evaluation and Research's proposal to refuse approval of Vanda's supplemental new drug application for Hetlioz in the treatment of jet lag disorder.
The request for the hearing was approved by the U.S. Food and Drug Administration on March 2, the company said. A hearing will be held and a presiding officer will issue an initial decision, it added.
According to Vanda, the FDA has not granted such a hearing in the context of drug approvals for potentially over 40 years.
Year Long Efforts At Approval
However, the FDA has rejected Vanda's application for a jet lag indication multiple times, most recently in January 2026. While the FDA acknowledged positive results from Vanda’s clinical trials earlier this year, it cited concerns that the controlled phase-advance protocols used in the studies do not fully replicate real-world jet travel conditions, including reduced oxygen pressure, noise, and lighting changes.
Prior to that, the FDA rejected the company’s application in 2019. However, a court ordered re-review in August 2025, opining that the FDA unlawfully failed to adequately engage with Vanda's evidence and criticized the agency's cursory treatment of expert, evidence-based submissions.
How Did Stocktwits Users React?
On Stocktwits, retail sentiment around VNDA stock stayed within the ‘neutral’ territory over the past 24 hours, while message volume fell from ‘high’ to ‘low’ levels.
VNDA stock has gained 66% over the past 12 months.
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