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Vanda Pharmaceuticals Inc

For the period ended Feb 13, 2025. Filed Feb 13, 2025.

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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.

Feb 13, 2025 · Filed Feb 13, 2025

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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 and 2030 Revenue Targets” above and the related implied growth of Vanda’s business, and statements regarding Vanda’s plans for pursuit of FDA approval of Bysanti TM for the treatments of acute bipolar I disorder and schizophrenia and imsidolimab for the treatment of GPP, and the related timelines; Vanda’s expectations with respect to the growth opportunities for its psychiatry frachise; Vanda’s consideration of foreign regulatory approval for imsidolimab and its potential development for other inflammatory disorders; Vanda’s clinical development plans and expected timelines for Fanapt® LAI, Bysanti TM for the treatment of MDD, VQW-765 for the treatment of acute performance anxiety in social situations, and VCA-894A for the treatment of CMT2S; the commercial and therapeutic potential for Bysanti TM; the potential to extend patent exclusivity for Bysanti TM into the 2040s; the anticipated timing of the initiation and completion of technology transfer activities and the preparation of regulatory filings in the US and EU for imsidolimab; and the prevalence of PV 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 psychiatry portfolio and overall business; the results of Vanda’s review of foreign regulatory opportunities for imsidolmab; Vanda’s ability to identify additional indications for imsidolimab; Vanda’s ability to complete and submit to the FDA the NDA for Bysanti TM for the treatments of acute bipolar I disorder and schizophrenia in the first quarter of 2025; Vanda’s ability to complete and submit the BLA for imsidolimab for the treatment of GPP in 2025; Vanda’s ability to complete the Phase III clinical study for Bysanti TM for MDD and receive results in 2026; Vanda’s ability to initiate the Phase III program for VQW-765 in 2025; Vanda’s ability to enroll the CMT2S patient in the Phase I clinical study for VCA-894A by mid-2025; Vanda’s ability to complete the clinical development of, obtain regulatory approval for, and successfully commercialize, Bysanti TM for the treatments of acute bipolar I disorder, schizophrenia and MDD; Vanda’s ability to satisfy the conditions necessary to extend Bysanti TM’s patent exclusivity into the 2040s; Vanda’s ability to initiate and complete the technology transfer activities and prepare the BLA and MAA for imsidolimab in the specified timeframes; and the accuracy of the estimate regarding the prevalence of PV. 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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