Vanda Pharmaceuticals Announces Collaborative Framework for Resolution of Disputes with the U.S. Food and Drug Administration

Rhea-AI Summary

Vanda Pharmaceuticals (Nasdaq: VNDA) has reached a collaborative framework with the FDA to resolve multiple regulatory disputes regarding HETLIOZ® and tradipitant. The agreement includes expedited reviews of several key applications: the partial clinical hold on tradipitant for motion sickness by November 26, 2025, the NDA review with a PDUFA date of December 30, 2025, and the sNDA for HETLIOZ® for jet lag disorder by January 7, 2026.

As part of the agreement, Vanda will dismiss multiple lawsuits against the FDA, including challenges to the clinical hold on tradipitant and HETLIOZ® efficacy information sharing. The framework also includes temporary pauses in various administrative proceedings and legal actions to facilitate the resolution process.

Positive

• Expedited FDA re-review timeline established for multiple drug applications
• Potential resolution path for HETLIOZ® jet lag disorder indication
• Framework provides clarity on regulatory timeline for tradipitant motion sickness indication
• Collaborative approach with FDA may improve relationship with regulator

Negative

• Multiple ongoing regulatory disputes indicate historical challenges with FDA
• Current clinical hold on long-term tradipitant studies remains in effect
• Uncertainty in final outcomes of FDA reviews despite framework agreement

Insights

Pharmaceutical Regulatory Affairs Expert

Vanda and FDA agree to expedite reviews for two drugs and pause litigation, creating clearer regulatory pathways with defined timelines.

This collaborative framework between Vanda Pharmaceuticals and the FDA marks a significant de-escalation in what appears to have been a contentious regulatory relationship. The agreement establishes concrete timelines for expedited regulatory reviews while pausing or dismissing multiple legal proceedings.

The agreement covers two key Vanda products. For tradipitant, the FDA will conduct an expedited re-review of the partial clinical hold by November 26, 2025, potentially allowing long-term clinical studies for motion sickness to proceed. The agency will also continue reviewing tradipitant's NDA with a PDUFA date of December 30, 2025. Additionally, administrative proceedings for tradipitant's gastroparesis indication will be paused until January 7, 2026.

For HETLIOZ® (tasimelteon), the FDA will conduct an expedited re-review of the supplemental NDA for jet lag disorder by January 7, 2026, with the agency considering alternative or narrowed indications focused on sleep-related aspects of the condition.

The resolution of these disputes removes significant regulatory uncertainty and creates a more structured path forward. The agreement to pause litigation challenging the FDA's extended timeframe for reviewing NDAs (beyond the statutory 180 days) and the dismissal of lawsuits regarding the partial clinical hold and information provision to prescribers indicates a mutual willingness to resolve differences through administrative channels rather than litigation.

This framework provides clarity on regulatory timelines with specific dates to monitor in late 2025 and early 2026. While this agreement doesn't guarantee eventual approvals, it does establish procedural certainty and potentially accelerates regulatory pathways for multiple indications, removing obstacles that had previously delayed Vanda's development programs.

WASHINGTON, Oct. 1, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has agreed on a collaborative framework with the U.S. Food and Drug Administration (FDA) for the resolution of certain disputes regarding HETLIOZ^® (tasimelteon) and tradipitant.

Key features of the agreement include:

• The FDA will conduct an expedited re-review of the partial clinical hold preventing long term clinical studies of tradipitant for the treatment of motion sickness by November 26, 2025. The FDA will continue its review of Vanda's New Drug Application (NDA) for this indication, with the existing Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025.
• The FDA will conduct an expedited re-review of Vanda's supplemental New Drug Application (sNDA) for HETLIOZ^® for the treatment of jet lag disorder by January 7, 2026, including consideration of alternative or narrowed indications focusing on the sleep-related aspects of jet lag disorder. During the re-review, Vanda and the FDA will seek a temporary pause of the Part 12 proceedings that result from the D.C. Circuit's recent decision in Vanda Pharmaceuticals v. FDA, No. 24-1049 (D.C. Cir.).
• The FDA and Vanda will seek a temporary pause of the ongoing administrative proceedings before the FDA Commissioner for Vanda's NDA for tradipitant for the treatment of gastroparesis, until January 7, 2026.
• Vanda and the FDA have sought a pause in Vanda's lawsuit challenging the FDA's practice of taking up to 12 months—rather than the statutory 180 days—to decide new drug applications, Vanda Pharms. Inc. v. FDA, Nos. 24-cv-351 and 25-cv-536 (D.D.C.).
• Vanda will dismiss its lawsuit challenging the FDA's partial clinical hold preventing long term studies of tradipitant for the treatment of motion sickness, Linn v. FDA, No. 2:25-cv-32 (M.D. Fla.).
• Vanda will dismiss its lawsuit regarding Vanda's request to provide information to prescribers and patients regarding the efficacy of HETLIOZ^® in jet lag disorder, Vanda Pharms. Inc. v. FDA, No. 4:25-cv-1648 (S.D. Tex.).

About Vanda Pharmaceuticals Inc.

Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Various statements in this press release, including, but not limited to statements regarding the actions that the FDA is expected to take, and the timing thereof, with respect to the NDA for tradipitant for the treatment of motion sickness and the sNDA for HETLIOZ^® for the treatment of jet lag disorder, and the actions that Vanda and the FDA are expected to take with respect to certain of their ongoing administrative proceedings and litigation, are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, the FDA's ability to conduct expedited re-reviews of the partial clinical hold on tradipitant for the treatment of motion sickness by November 26, 2025 and the sNDA for HETLIOZ^® for the treatment of jet lag disorder by January 7, 2026, the FDA's ability to complete its review of the NDA for tradipitant for the treatment of motion sickness by the existing PDUFA target action date of December 30, 2025, and the results of the FDA's review of the NDA for tradipitant for the treatment of gastroparesis. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized, or even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.

All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com

Jim Golden / Jack Kelleher / Dan Moore
Collected Strategies
VANDA-CS@collectedstrategies.com

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SOURCE Vanda Pharmaceuticals Inc.

FAQ

What is the agreement between Vanda Pharmaceuticals (VNDA) and the FDA?

Vanda and the FDA have established a collaborative framework to resolve disputes regarding HETLIOZ® and tradipitant, including expedited reviews of applications and temporary pauses in various legal proceedings.

When will the FDA complete its review of Vanda's tradipitant for motion sickness?

The FDA will conduct an expedited re-review of the partial clinical hold by November 26, 2025, with a PDUFA target action date of December 30, 2025.

What is the timeline for FDA's review of HETLIOZ® for jet lag disorder?

The FDA will conduct an expedited re-review of the supplemental New Drug Application (sNDA) for HETLIOZ® by January 7, 2026, including consideration of alternative or narrowed indications.

Which lawsuits will Vanda Pharmaceuticals dismiss as part of the FDA agreement?

Vanda will dismiss lawsuits challenging the FDA's partial clinical hold on tradipitant for motion sickness and the lawsuit regarding HETLIOZ® efficacy information sharing with prescribers and patients.

How does this framework agreement affect Vanda's ongoing FDA disputes?

The agreement temporarily pauses several administrative proceedings and legal actions, allowing for expedited reviews while working toward resolving multiple regulatory disputes.