Vanda Faces FDA Setback on HETLIOZ Jet Lag Application

Vanda ( (VNDA) ) has issued an announcement.

On January 7, 2026, Vanda Pharmaceuticals received a decision letter from the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research concluding that the supplemental New Drug Application for HETLIOZ® (tasimelteon) for the treatment of jet lag disorder could not be approved in its current form, despite the agency’s earlier agreement to conduct an expedited re-review under an October 2025 collaborative framework. The FDA acknowledged positive efficacy signals in Vanda’s controlled trials but found the data insufficient as substantial evidence of effectiveness, arguing that the phase-advance sleep models used in the studies do not adequately mirror real-world jet travel conditions. Vanda disputes this assessment, insisting that phase-advance models are widely accepted in circadian research and that its data, including simulated and actual transatlantic travel studies, demonstrate meaningful benefits for sleep and next-day alertness, supported by a well-established safety profile over more than a decade of use in other indications. The setback follows an August 2025 D.C. Circuit decision that had criticized the FDA’s prior review as cursory and vacated its earlier refusal, and Vanda now signals it will continue to engage with the regulator and pursue avenues to secure approval for the jet lag indication, a move with potential implications for the company’s growth prospects in the sleep-disorder market and for travelers seeking targeted treatment options.

The most recent analyst rating on (VNDA) stock is a Buy with a $22.00 price target. To see the full list of analyst forecasts on Vanda stock, see the VNDA Stock Forecast page.

Spark’s Take on VNDA Stock

According to Spark, TipRanks’ AI Analyst, VNDA is a Neutral.

The score is held back primarily by weak financial performance—worsening losses and significant free cash flow burn—despite a strong, low-debt balance sheet. Technicals are supportive with strong trend and momentum, while valuation is constrained by ongoing losses and no dividend. Earnings call updates and recent FDA-related events add moderate upside via improving sales execution and pipeline/regulatory progress.

To see Spark’s full report on VNDA stock, click here.

More about Vanda

Vanda Pharmaceuticals Inc. is a global biopharmaceutical company focused on developing and commercializing innovative therapies for high unmet medical needs, particularly in sleep and circadian rhythm disorders. Its key product HETLIOZ®, a melatonin-receptor agonist, is already approved in the United States for Non‑24‑Hour Sleep‑Wake Disorder and nighttime sleep disturbances associated with Smith‑Magenis Syndrome.

Average Trading Volume: 1,573,843

Technical Sentiment Signal: Buy

Current Market Cap: $480.5M

For a thorough assessment of VNDA stock, go to TipRanks’ Stock Analysis page.