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

• Vanda said it disagrees with the FDA assessment, noting that phase-advance models are widely accepted in circadian rhythm research.
• The company emphasized Tasimelteon’s well-established safety profile. 
• The company had recently received FDA approval for NEREUS (Tradipitant), a motion-sickness treatment aimed at preventing vomiting.

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.

This comes after the company received FDA approval for NEREUS (Tradipitant), a motion-sickness treatment aimed at preventing vomiting on December 31, 2025.

The FDA approval marked the first new pharmacologic treatment for motion sickness in more than 40 years. Vanda expects to launch NEREUS in the coming months. Beyond motion sickness, Vanda is advancing tradipitant in clinical development for other conditions driven by similar pathways, including gastroparesis and nausea linked to GLP-1 therapies. 

How Did Stocktwits Users React?

Despite the intraday decline, retail sentiment on Stocktwits turned 'bullish' from 'neutral' a day earlier. 

One bullish user sees strong buy at this level, stating that the motion sickness drug approval is a much bigger news than today's update.

Over the past one year, VNDA shares have gained around 52%.

For updates and corrections, email newsroom[at]stocktwits[dot]com.

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