Vanda Pharmaceuticals Fanapt (iloperidone) Receives U.S. FDA Approval for the Acute Treatment of Bipolar I Disorder Fanapt Treatment is Now Available to Adult Patients for the Acute Treatment of Manic or Mixed Episodes A

Vanda Pharmaceuticals Fanapt

(iloperidone) Receives U.S. FDA Approval

for the Acute Treatment of Bipolar I Disorder

Fanapt Treatment is Now Available to Adult Patients for the

Acute Treatment of Manic or Mixed Episodes Associated with Bipolar I Disorder

Approval Represents Significant Novel Indication for Vanda s Fanapt Franchise

WASHINGTON, April 2, 2024 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and

Drug Administration (FDA) has approved Fanapt (iloperidone) tablets for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. Fanapt is an atypical antipsychotic agent that has been used for the acute treatment of patients with schizophrenia since its FDA approval in 2009.

Manic or mixed episodes associated with bipolar I disorder are highly complex conditions, which require a host of trusted options to meet individual

patient needs. With over 100,000 patient years of experience, Fanapt is a familiar therapeutic agent that offers flexible dosing with a well-known safety profile. This FDA approval gives patients and service providers a new treatment option for

managing bipolar I disorder, said Mihael H. Polymeropoulos M.D., Vanda s President, CEO and Chairman of the Board.

Bipolar disorder is a

serious, highly prevalent psychiatric chronic condition affecting approximately 2.8% of the U.S. adult population, with 83% of them classified as severe1. Bipolar disorder is a group of disorders

that are characterized by periods of elevated mood alternating with periods of depressed mood. For the diagnosis of bipolar I disorder, people must have experienced one or more episodes of mania and most would have episodes of both mania and

depression. Patients with bipolar I disorder with manic or mixed episodes are a subset of those approximately 10 million Americans with bipolar disorder1. The marketing approval of Fanapt in bipolar I disorder with manic and mixed episodes significantly increases the commercial opportunity for Fanapt .

Stephen Stahl, MD, PhD, Professor of Psychiatry at the University of California San Diego, said, Many patients today are still unable to find suitable

treatment options for effectively managing bipolar disorder. Tailoring the right treatment for the right patient is critical for effective care, and the approval of Fanapt represents an important milestone. Fanapt possesses a well-studied safety

profile, and its approval will provide patients with a new and effective option for treating a highly complex disorder.

The approval of Fanapt for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder was based on a pivotal study randomizing approximately 400 patients. The primary endpoint

measured in Week 4 of treatment was assessed by the Young Mania Rating Scale (YMRS), a rating scale of clinical severity in the core symptoms of mania. At the end of the study (Week 4),

Fanapt treated patients showed a larger improvement than placebo treated patients, and this difference was highly statistically significant (p=0.000008). YMRS was assessed at the end of

Weeks 1, 2, 3 and 4. Statistically significant benefit in the Fanapt treated group over placebo was observed as early as the Week 2 assessment. The safety profile of Fanapt in this study was similar to that seen in Fanapt studies previously conducted for

the treatment of schizophrenia in adults.

Dr. Polymeropoulos continued, Today s announcement marks a significant step forward for one

of Vanda s leading franchises and underscores the effectiveness of our strategy in pursuing innovative therapies that address high unmet medical needs to improve the lives of patients. With this as our foundation, we have established a

resilient business, with a diverse product pipeline, a history of revenue growth and strong financial position. We remain focused on providing critical medicines to patients across the world while creating sustainable, long-term value.

1. Harvard Medical School,

2007. National Comorbidity Survey (NSC). (2017, August 21). Retrieved from https://www.hcp.med.harvard.edu/ncs/index.php

Pharmaceuticals Inc.

Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to

For full U.S. Prescribing Information for Fanapt , including indication, Boxed Warnings and Important

Safety Information, visit our Web site at www.fanapt.com.

INDICATION AND IMPORTANT SAFETY INFORMATION

Fanapt (iloperidone) is indicated for the treatment of schizophrenia in adults and the acute

treatment of manic or mixed episodes associated with bipolar I disorder in adults. Titrate the dosage of Fanapt to avoid orthostatic hypotension.

BOXED WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS:

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Fanapt is not approved for use in patients with dementia-related psychosis.

WARNING AND PRECAUTIONS

USE IN SPECIFIC POPULATIONS

Please see full Prescribing Information,

including BOXED WARNING.

CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

Various statements in this release, including, but not limited to statements regarding Vanda s ability to make Fanapt available to patients with manic or mixed episodes associated with bipolar I disorder and the commercial opportunity for Fanapt , 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, market

acceptance of Fanapt as an acute treatment for adults with manic or mixed episodes associated with bipolar I disorder, Vanda s dependence on third-party manufacturers to manufacture

Fanapt in sufficient quantities and quality, and the effectiveness of Vanda s sales and marketing infrastructure. 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.

Senior Vice President, Chief Financial Officer and

Vanda Pharmaceuticals Inc.

Jim Golden / Jack Kelleher / Dan Moore

Collected Strategies