Vanda Stock Drops 10% Premarket After FDA Rejects Jet Lag Drug Application

The FDA cited concerns that the controlled phase advance protocols used in studies do not fully replicate real-world jet travel conditions.

Shares of Vanda Pharmaceuticals Inc. (VNDA) fell 10% in premarket trading on Thursday after the company announced that the U.S. Food and Drug Administration (FDA) stated that its supplemental New Drug Application for HETLIOZ (tasimelteon) to treat jet lag disorder cannot be approved in its current form.

While the FDA acknowledged positive results from Vanda’s clinical trials, 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.

Vanda said it disagrees with the FDA assessment, noting that phase-advance models are widely accepted in circadian rhythm research and effectively simulate core jet-lag symptoms. The company emphasized tasimelteon’s well-established safety profile and demonstrated benefits on sleep and next-day alertness.

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