Vanda Pharmaceuticals Inc.
For the period ended Jul 31, 2025. Filed Jul 31, 2025.
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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.
Jul 31, 2025 · Filed Jul 31, 2025
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Contents
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; Vanda’s near-term revenue expectations for Fanapt®; the potential commercial availability of Bysanti™ and tradipitant; and Vanda’s clinical development plans and expected timelines for Bysanti TM for the treatment of MDD; 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, 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 2025; Vanda’s ability to increase market awareness of Fanapt® for the acute treatment of bipolar I disorder and continue to drive Fanapt® revenue growth; Vanda’s ability to obtain FDA approval of Bysanti™ and tradipitant and successfully execute their commercial launches; and Vanda’s ability to complete the Phase III clinical study for Bysanti TM for MDD and receive results in 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.
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