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Vanda Pharmaceuticals Inc

For the period ended Nov 6, 2024. Filed Nov 6, 2024.

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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.

Nov 6, 2024 · Filed Nov 6, 2024

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VNDA$3.82+6.4%Stored close · as of Nov 6, 2026
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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 “2024 Financial Guidance” above, and statements regarding Vanda’s plans to strengthen and grow its business and diversify its sources of revenue; Vanda’s plans for pursuit of FDA approval of milsaperidone for the treatments of schizophrenia and acute bipolar I disorder, tradipitant for the treatments of motion sickness and gastroparesis, and HETLIOZ® for the treatments of jet lag disorder and insomnia; European Medicines Agency action on the Marketing Authorization Application for HETLIOZ® and HETLIOZ LQ® for Smith-Magenis Syndrome; Vanda’s clinical development plans for milsaperidone for the treatment of MDD, the LAI formulation of Fanapt®, PONVORY® for the treatments of psoriasis and ulcerative colitis, tradipitant for the prevention of vomiting induced by a GLP-1 analog, VSJ-110 for the treatment of dry eye,VPO-227 for the treatment of cholera, VCA-894A for the treatment of CMT2S, VTR-297 for the treatment of onychomycosis and VQW-765 for the treatment of acute performance anxiety in social situations; the initial market response to the commercial launch of Fanapt® for the acute treatment of bipolar I in adults; the prevalence of pediatric sleep disorders; the regulatory status of Vanda’s Marketing Authorization Application for HETLIOZ® and HETLIOZ LQ® for SMS in Europe and its NDA for tradipitant for the treatment of symptoms of gastroparesis in the U.S.; and Vanda’s plans to continue to support the tradipitant expanded access program for gastroparesis patients 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 correct the deficiencies identified by the FDA in the CRL with respect to the NDA for tradipitant for the treatment of symptoms of gastroparesis; Vanda’s ability to complete and submit to the FDA the NDAs for tradipitant for the treatment of motion sickness and milsaperidone for the treatments of schizophrenia and acute bipolar I disorder within the specified timeframes; the FDA’s assessment of the sufficiency of the data packages to be included in the NDAs for tradipitant and milsaperidone; Vanda’s ability to correct the deficiencies identified by the FDA in the Complete Response Letter (CRL) with respect to the sNDA for HETLIOZ® for the treatment of insomnia; the outcome in the U.S. Court of Appeals of Vanda’s challenge to the FDA’s rejection of its sNDA for HETLIOZ® for the treatment of jet lag disorder; the accuracy of the lead indicators regarding the initial market response to the commercial launch of Fanapt® for the acute treatment of bipolar I disorder in adults; Vanda’s ability to initiate the Phase III programs for milsaperidone for MDD and the LAI formulation of Fanapt® by the end of 2024; the accuracy of the estimates regarding the prevalence of pediatric sleep disorders; Vanda’s ability to file the INDs for PONVORY® for the treatments of psoriasis and ulcerative colitis by the end of 2024; Vanda’s ability to initiate the Phase I study for VPO-227 for the treatment of cholera by the end of 2024; Vanda’s ability to enroll the patient for the Phase I study for VCA-894A for the treatment of CMT2S by the end of 2024; and Vanda’s ability to complete the Phase I study of VTR-297 for the treatment of onychomycosis by the end of 2024. 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 “Caut ionary 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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