Vanda Pharmaceuticals Provides Regulatory Update on Tradipitant for Motion Sickness

Rhea-AI Summary

Vanda Pharmaceuticals (Nasdaq: VNDA) provided regulatory updates on tradipitant for motion sickness on November 28, 2025.

The FDA is conducting an expedited re-review of a partial clinical hold that limits long-term tradipitant studies; the target completion date was extended from November 26, 2025 to December 5, 2025 at the FDA's request to accommodate CDER personnel and leadership transitions. Separately, the New Drug Application (NDA) review remains on schedule with an unchanged PDUFA target action date of December 30, 2025. The FDA has issued labeling comments and formal labeling discussions with Vanda have begun.

Vanda said it looks forward to potentially delivering the first new pharmacologic treatment for motion sickness in over four decades.

Positive

• NDA review remains on schedule with PDUFA date Dec 30, 2025
• Formal labeling discussions with FDA have commenced

Negative

• Partial clinical hold currently restricts long-term tradipitant studies
• FDA extended expedited re-review target to Dec 5, 2025

News Market Reaction

+1.13%

1 alert

+1.13% News Effect

On the day this news was published, VNDA gained 1.13%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Re-review completion date: December 5, 2025 PDUFA target action date: December 30, 2025

2 metrics

Re-review completion date December 5, 2025 Expedited FDA re-review of partial clinical hold on tradipitant

PDUFA target action date December 30, 2025 Tradipitant NDA for prevention of motion-induced vomiting

Market Reality Check

Price: $7.78 Vol: Volume 1,684,297 vs 20-da...

normal vol

$7.78 Last Close

Volume Volume 1,684,297 vs 20-day average 1,196,487 (relative volume 1.41x) ahead of this regulatory update. normal

Technical Price $6.60 is trading above the 200-day MA at $4.69, reflecting a recovery from prior levels.

Peers on Argus

VNDA is up 11.39% while close peers show mixed moves (e.g., CADL up 13.11%, OMER...

VNDA is up 11.39% while close peers show mixed moves (e.g., CADL up 13.11%, OMER down 4.51%), indicating a stock-specific reaction rather than a broad biotech move.

Historical Context

5 past events · Latest: Dec 04 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 04	FDA hold lifted	Positive	-0.8%	FDA removed partial clinical hold, allowing extended tradipitant dosing.
Nov 28	Regulatory update	Positive	+1.1%	FDA re-review timeline extended; NDA review and PDUFA date unchanged.
Nov 17	Clinical data update	Positive	+1.1%	Tradipitant reduced GLP‑1–induced vomiting with favorable safety profile.
Nov 05	Conference participation	Neutral	-0.7%	Announced participation and webcast details for Stifel healthcare conference.
Oct 29	Earnings and pipeline	Negative	-3.0%	Q3 loss and lowered 2025 guidance alongside multiple PDUFA milestones.

Pattern Detected

Recent VNDA news has usually seen modest alignment between news tone and price, with one divergence when a clearly positive FDA decision saw a small negative move.

Recent Company History

Over the last few months, Vanda has reported several regulatory and clinical milestones. Q3 2025 results showed higher sales but a net loss and lowered guidance on Oct 29, 2025. Subsequent news highlighted conference participation and positive tradipitant data for GLP‑1–induced nausea on Nov 17, 2025. On Nov 28, 2025, Vanda outlined FDA timelines for the tradipitant motion sickness program, followed by the FDA lifting the partial clinical hold on Dec 4, 2025. Today’s update fits this continuing regulatory progression for tradipitant.

Market Pulse Summary

This announcement clarified FDA timelines for tradipitant in motion sickness: the expedited re-revie...

Analysis

This announcement clarified FDA timelines for tradipitant in motion sickness: the expedited re-review of the partial clinical hold now targets completion by December 5, 2025, while the NDA PDUFA date remains December 30, 2025. It signals that review activities and formal labeling discussions are underway without altering key decision dates. Investors may track subsequent FDA communications on the hold outcome, label details, and how these align with Vanda’s broader pipeline milestones and recent financial performance.

Key Terms

partial clinical hold, new drug application, pdufa, center for drug evaluation and research

4 terms

partial clinical hold regulatory

"expedited re-review of the partial clinical hold that currently restricts long-term"

A partial clinical hold is a temporary restriction imposed by health regulators that pauses certain parts of a medical trial while allowing others to continue. For investors, it signals potential delays or issues with a company's development of new treatments, which can impact future growth prospects. It’s like putting a project on hold in some areas while others keep moving forward.

new drug application regulatory

"labeling discussions have formally begun for the New Drug Application of tradipitant"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

pdufa regulatory

"New Drug Application of tradipitant ... (PDUFA target action date remains December 30, 2025)"

PDUFA, short for the Prescription Drug User Fee Act, is a law that allows drug companies to pay fees to the government to speed up the review process for new medicines. This helps bring important drugs to market more quickly, which can impact their availability and pricing. For investors, PDUFA timelines can influence the timing of a drug’s approval and potential market success.

center for drug evaluation and research regulatory

"to accommodate recent personnel and leadership transitions within the Center for Drug Evaluation and Research"

A U.S. federal regulatory office that reviews and decides whether new and existing prescription and over‑the‑counter drugs are safe and effective for patients. Its decisions set the rules for whether a medicine can be sold, what claims can be made about it, and what warnings are required. Investors watch it like a gatekeeper: approval unlocks market access and revenue, while delays or rejections create risk and uncertainty for a drug maker.

AI-generated analysis. Not financial advice.

• FDA requests, and Vanda agrees to, a brief extension (to December 5, 2025) for the expedited re-review of the partial clinical hold on long-term studies
  
  
• Separately, FDA recently issued labeling comments, and labeling discussions have formally begun for the New Drug Application of tradipitant for the prevention of vomiting induced by motion (PDUFA target action date remains December 30, 2025)

WASHINGTON, Nov. 28, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA), today announced the following updates regarding tradipitant for motion sickness:

Partial Clinical Hold Re-Review Timeline

Under the collaborative framework announced on October 1, 2025, the U.S. Food and Drug Administration (FDA) is conducting an expedited re-review of the partial clinical hold that currently restricts long-term clinical studies of tradipitant in motion sickness. The original target completion date was November 26, 2025. At the FDA's request, and with Vanda's agreement, the target completion date has been extended to December 5, 2025 to accommodate recent personnel and leadership transitions within the Center for Drug Evaluation and Research (CDER). All other provisions of the collaborative framework remain unchanged.

New Drug Application (NDA) Progress

Separately, review of the NDA for tradipitant for the prevention of vomiting induced by motion continues according to schedule, with an unchanged PDUFA target action date of December 30, 2025. The FDA has recently issued comments on the proposed labeling, and labeling discussions between the FDA and Vanda have now formally commenced. Vanda looks forward to potentially delivering the first new pharmacologic treatment for motion sickness in over four decades.

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.

About Tradipitant

Tradipitant is a neurokinin-1 receptor antagonist licensed by Vanda from Eli Lilly and Company. Tradipitant is currently in clinical development for a variety of indications, including gastroparesis, motion sickness, and the prevention of nausea and vomiting induced by GLP-1 receptor agonists.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Various statements in this press release, including, but not limited to statements regarding the FDA's re-review of the partial clinical hold on tradipitant, the FDA's continuing review of the tradipitant NDA and the related timeline, the status of the label for tradipitant for the treatment of motion sickness, and the potential commercialization of tradipitant for such indication 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 complete its re-review of the partial clinical hold on tradipitant by December 5, 2025, the FDA's ability to complete its review of the NDA for tradipitant for the treatment of motion sickness by December 30, 2025, the outcome of the labeling discussions between Vanda and the FDA, and the FDA's assessment of the evidence supporting the safety and efficacy of tradipitant for the treatment of motion sickness. 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

 

View original content to download multimedia:https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-provides-regulatory-update-on-tradipitant-for-motion-sickness-302627878.html

SOURCE Vanda Pharmaceuticals Inc.

FAQ

What did Vanda announce about tradipitant and the partial clinical hold (VNDA) on Nov 28, 2025?

Vanda said the FDA is doing an expedited re-review of the partial clinical hold and the target completion date was extended to Dec 5, 2025.

Is the tradipitant NDA review for VNDA still on schedule and what is the PDUFA date?

Yes; the NDA review remains on schedule with an unchanged PDUFA target action date of Dec 30, 2025.

What does the FDA labeling update mean for VNDA tradipitant?

The FDA issued labeling comments and formal labeling discussions with Vanda have now begun, which is a standard step before potential approval.

How long is the FDA re-review extension for the tradipitant partial clinical hold (VNDA)?

The FDA and Vanda agreed to extend the expedited re-review target completion date to Dec 5, 2025 from Nov 26, 2025.

Does the Nov 28, 2025 update change the tradipitant approval timeline for VNDA?

The update extended the re-review of the partial clinical hold to Dec 5, 2025, but the NDA PDUFA date remains Dec 30, 2025.