Vanda Pharmaceuticals Announces Receipt of FDA Decision Letter on HETLIOZ® Supplemental New Drug Application for Jet Lag Disorder

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WASHINGTON, Jan. 8, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today ann...

AI Summary

Vanda Pharmaceuticals faced a setback as the FDA rejected its supplemental New Drug Application for HETLIOZ® aimed at treating jet lag disorder, citing insufficient evidence. Vanda contests this interpretation, arguing their clinical trial data supports its effectiveness and plans to engage further with the FDA for eventual approval.

Trading Thesis

Investors should monitor VNDA for potential FDA re-engagement outcomes influencing stock price.

Market-Moving

FDA decisions historically impact biopharma stocks significantly.
Investors could react negatively to the recent FDA rejection.
Future engagements between Vanda and the FDA are crucial.
Vanda’s existing products show stable market performance despite setbacks.
Pilot programs and trial outcomes could influence future approvals.

Key Facts

VNDA's HETLIOZ® is currently approved for Non-24-Hour Sleep-Wake Disorder.
Vanda asserts a strong safety profile for HETLIOZ®.
The FDA previously praised Vanda's evidence in earlier rulings.
Over 10 years of market experience support tasimelteon's profile.
The FDA's decision is part of a broader collaborative framework agreement.

Companies Mentioned

Vanda Pharmaceuticals Inc. (VNDA): Stock impacted by FDA's decision on HETLIOZ®.

Others

Vanda Pharmaceuticals operates in a highly regulated biopharmaceutical sector where FDA approvals critically influence stock performance. The current setback emphasizes the risk inherent in such investments, warranting close monitoring of FDA interactions.

FAQ

Why Bearish?

The FDA rejection directly undermines potential revenue from HETLIOZ®, leading to reduced investor confidence. Historical precedents indicate that FDA rejections often lead to falling stock prices for pharmaceutical companies reliant on new approvals.

How important is it?

The FDA's decision is significant due to its immediate implications for VNDA's product pipeline and investor sentiment. Given previous court backing, future FDA engagements hold substantial potential to influence VNDA's reputation and stock performance.

Why Short Term?

Investors will closely monitor VNDA's FDA engagements, impacting short-term stock movements. Long-term outcomes depend on successful reapplications or trials.

Related Companies

VRNA

Vanda Pharmaceuticals Faces FDA Decision on HETLIOZ® for Jet Lag Disorder

[Location], [Date] - Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) has announced that the U.S. Food and Drug Administration (FDA) has issued a decision letter regarding its supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) aimed at treating jet lag disorder. The FDA's conclusion indicates that the application cannot be approved in its present form, sparking a response from the pharmaceutical company.

FDA Decision Explained

The letter from the FDA's Center for Drug Evaluation and Research (CDER) reflects a re-evaluation of Vanda's jet lag application as part of a collaborative framework agreement established on October 1. Although the FDA acknowledged positive efficacy from Vanda's controlled clinical trials, it determined that the evidence presented does not sufficiently substantiate effectiveness for jet lag disorder.

The FDA's concerns primarily stem from the notion that the controlled phase advance protocols (involving 5-hour and 8-hour shifts in bedtime) do not accurately represent the complexities of actual jet travel, which include factors such as reduced oxygen levels, various physical constraints, noise, and changes in lighting.

Vanda's Response to FDA's Concerns

Vanda Pharmaceuticals firmly disagrees with the FDA's interpretation. The company argues that phase advance models are generally accepted within circadian rhythm research as valid tools for simulating the core misalignment associated with eastward jet lag, which contributes significantly to the primary symptoms as defined by ICSD-3 criteria. These models effectively replicate essential features of jet lag while excluding unrelated travel variations.

Further supporting its claims, Vanda cites convergent evidence from studies, including both simulated and actual transatlantic travel, demonstrating that tasimelteon is beneficial for:

Increased sleep duration
Reduced latency to persistent sleep
Enhanced alertness the following day

Moreover, tasimelteon's safety profile is well-established, listing primarily mild adverse effects and documenting over 10 years of market experience in other approved chronic indications.

Procedural Background and Future Steps

In a previous ruling in August 2025, the D.C. Circuit overturned an earlier FDA refusal to approve HETLIOZ® for jet lag disorder, highlighting Vanda's evidence as "specific, reasoned, and rooted in evidence." The Court criticized the FDA's prior review, labeling it "cursory," while recognizing statistically significant endpoint improvements in Vanda’s trials.

Following this ruling, a collaborative framework agreement was put in place in October 2025, with the FDA committing to a timely re-evaluation of the sNDA by January 7, 2026, focusing on specific, sleep-related indications. While Vanda appreciates the FDA's collaborative approach, it contends that the current decision does not align with the spirit of cooperation or adequately address the Court's directives concerning the evidence.

Vanda remains dedicated to working constructively with the FDA, pursuing all possible avenues to advance the approval of HETLIOZ® for jet lag disorder and to ensure the availability of this crucial therapy for travelers.

About Vanda Pharmaceuticals Inc.

Vanda Pharmaceuticals Inc. is a leading biopharmaceutical company committed to developing innovative therapies that address significant unmet medical needs, improving patient lives worldwide. For additional information about the company, visit www.vandapharma.com or follow them on social media @vandapharma.

About HETLIOZ®

HETLIOZ® is a melatonin-receptor agonist currently approved in the U.S. for the treatment of Non-24-Hour Sleep-Wake Disorder and sleep disturbances associated with Smith-Magenis Syndrome. For comprehensive U.S. prescribing information concerning HETLIOZ®, including indications and crucial safety information, please visit www.hetlioz.com.

Forward-Looking Statements

This announcement contains forward-looking statements pertaining to Vanda's objectives to engage constructively with the FDA regarding the approval of HETLIOZ® for jet lag disorder. Such statements carry risks and uncertainties which may cause actual outcomes to differ from expectations. Investors are encouraged to consider the associated risks, uncertainties, and the content of Vanda's filings with the Securities and Exchange Commission for more detailed information.