Skip to main content

Vanda Pharmaceuticals Inc.

For the period ended Oct 29, 2025. Filed Oct 29, 2025.

View on SEC.gov

About this filing

A notice of a major event between regular reports, such as results, a deal or a change of executives. It is often the first formal record of the news.

Oct 29, 2025 · Filed Oct 29, 2025

Use the contents to explore the available documents and sections.

VNDA$3.82+6.4%Stored close · as of Nov 6, 2026
See the whole filing, with its images and exhibits

EX-99.1 · CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

Various statements in this press release, including, but not limited to, the guidance provided under “2025 Financial Guidance” above and statements regarding Vanda’s plans for pursuit of FDA approval of Bysanti TM for the acute treatment of bipolar I disorder and the treatment of schizophrenia, tradipitant for the treatment of motion sickness, and imsidolimab for the treatment of GPP, and the related timelines and prospects for approval; the goals and expected results of Vanda’s commercial infrastructure investment strategy; Vanda’s expectations with respect to the strength of its business; Vanda’s clinical development plans and expected timelines for tradipitant in the prevention of vomiting induced by Wegovy®, Bysanti TM for the treatment of MDD and the long acting injectable formulation of iloperidone in the treatments of schizophrenia in relapse-prevention and hypertension; andthe 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 disorderare “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, Vanda’s ability to continue to grow its business; the FDA’s ability to complete its reviews of, and reach decisions with respect to, the NDAs for Bysanti™ and tradipitant by their respective PDUFA target action dates; Vanda’s ability to complete and submit the BLA for imsidolimab in the fourth quarter of 2025; Vanda’s ability to achieve long-term market leadership and execute new commercial launches through its commercial infrastructure investments; Vanda’s ability to complete the clinical studies for tradipitant in the prevention of vomiting induced by Wegovy® and Bysanti TM for the treatment of MDD and receive results in the expected timeframes; Vanda’s ability to complete enrollment of patients in the clinical study for the long acting injectable formulation of iloperidone in the treatment of schizophrenia in relapse-prevention and to begin enrolling patients in the study of the long acting injectable formulation of iloperidone for the treatment of hypertension in the expected timeframe; and 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. 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 atwww.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.

ContentsView on SEC.gov

The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.