Vanda Pharmaceuticals Inc.
For the period ended Oct 28, 2026. Filed Oct 28, 2026.
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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.
Oct 28, 2026 · Filed Oct 28, 2026
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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 “2026 Financial Guidance” above and statements regarding the expected timing of the commercial launch of BYSANTI™ for the treatment of bipolar I disorder and schizophrenia; the anticipated timing of the completion of the FDA’s review of the Quimilza™ BLA for the treatment of GPP; Vanda’s plans and expectations regarding the regulatory path for NEREUS™ for the prevention of vomiting associated with GLP-1 receptor agonist therapy; Vanda’s clinical development and regulatory plans and expected timeline for HETLIOZ® in the treatment of DSWPD; Vanda’s expectations with respect to its operating expense run rate; Vanda’s clinical development plans and expected timeline for BYSANTI™ for the treatment of MDD; Vanda’s continued pursuit of FDA approval of HETLIOZ® for the treatment of jet lag disorder and Vanda’s expectations with respect to the HETLIOZ® evidentiary hearing; Vanda’s continued pursuit of FDA approval of HETLIOZ® for the treatment of insomnia and NEREUS™ for the treatment of gastroparesis; and Vanda’s expectations with respect to the strength of its business 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; Vanda’s ability to successfully execute the commercial launch of BYSANTI™ for the treatments of bipolar I disorder and schizophrenia in Q4 2026; Vanda’s ability to successfully launch and commercialize its recently approved products and any product that may be approved in the future; Vanda’s ability to continue to reduce its operating expenses; the FDA’s ability to complete its review of, and reach a decision with respect to, the BLA for Quimilza™ by December 12, 2026; the FDA’s willingness to meet with Vanda to discuss the NEREUS™ Phase III clinical study results and Vanda’s ability to gain alignment with the FDA on the regulatory path for NEREUS™ and submit an sNDA for NEREUS™ for the prevention of vomiting associated with GLP-1 receptor agonist therapy; the FDA’s willingness to meet with Vanda to discuss the HETLIOZ® Phase III clinical study results and Vanda’s ability to gain alignment with the FDA on the regulatory path for HETLIOZ® in the treatment of DSWPD and to obtain regulatory approval of HETLIOZ® for this indication; Vanda’s ability to meet its enrollment target for, and complete, the Phase III study for BYSANTI™ for the treatment of MDD and receive results in the first half of 2027; and the outcomes of the administrative hearing process for HETLIOZ® for the treatment of jet lag disorder and the court cases for HETLIOZ® for the treatment of insomnia and NEREUS™ for the treatment of gastroparesis. 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.
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