Vanda Pharmaceuticals

Vanda Pharmaceuticals, Inc. engages in the development and commercialization of therapies for high unmet medical needs. The firm intends to treat schizophrenia, jet lag disorder, atopic dermatitis, central nervous system disorders, and circadian rhythm sleep disorder. Its product portfolio includes HETLIOZ, Fanapt, Tradipitant, Trichostatin, and AQW051. The company was founded by Mihael Hristos Polymeropoulos and Argeris N. Karabelas in 2002 and is headquartered in Washington, DC.

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Vanda Pharmaceuticals reports mixed Q4 results amid legal challenges and opportunities

Vanda Pharmaceuticals faces financial challenges with declining revenues and HETLIOZ sales, offset by increased cash reserves and positive clinical trial outcomes.
Legal battles and uncertainties add complexity to the company's financial outlook, requiring strategic planning and risk management.
Despite hurdles, opportunities for growth exist through new drug applications, market expansion, and potential partnerships to drive future success.

Vanda Pharmaceuticals reports resilient Q1 performance amidst generic challenges

Vanda Pharmaceuticals delivered a strong performance in Q1 2023, navigating challenges from generic competition while focusing on growth opportunities.
The company's financial results and strategic initiatives position it well for future expansion and innovation in the pharmaceutical industry.
Despite uncertainties surrounding litigation and generic competition, Vanda remains resilient and committed to driving long-term value for stakeholders.

Vanda Pharmaceuticals navigates revenue decline, eyes regulatory approvals for growth

Vanda Pharmaceuticals faced revenue challenges due to generic competition impacting HETLIOZ sales, leading to a revenue decline.
Despite legal uncertainties and revenue setbacks, the company showcased strength in pipeline progress and operational cost management.
Management's confidence in regulatory outcomes and strategic flexibility positions Vanda for potential growth opportunities.

Vanda Pharmaceuticals reports revenue decline but maintains positive net income

Vanda Pharmaceuticals faces revenue challenges with declining total revenues and net product sales in 2023.
Despite this, the company maintains positive net income and focuses on upcoming FDA decisions for growth.
Strong leadership, operational efficiency, and a diversified product portfolio are key strengths for Vanda.
Exploring growth opportunities through FDA decisions, market expansion, and strategic initiatives is crucial for future success.

Vanda Pharmaceuticals reports revenue decline, pursues new treatments amid challenges

Vanda Pharmaceuticals faced revenue declines and net losses in Q4 2023, driven by challenges in product sales and market conditions.
Despite these setbacks, the company is strategically expanding its product portfolio and pursuing new treatments to drive future growth.
Navigating legal battles, generic competition, and market uncertainties will be key focus areas for Vanda in the coming year.

Vanda Pharmaceuticals navigates revenue challenges, eyes growth through strategic initiatives

Vanda Pharmaceuticals faced revenue challenges due to generic competition but remains focused on driving growth through commercial strategies.
The company's psychiatry portfolio expansion and ongoing clinical programs position it well for future market opportunities.
Addressing shareholder activism and evaluating takeover proposals while maintaining operational focus are key challenges ahead.
Engaging with the FDA for product approvals and planning strategic marketing initiatives offer avenues for revenue growth.

Vanda Pharmaceuticals reports revenue growth and strategic expansion plans

Vanda Pharmaceuticals is navigating a mixed financial performance with revenue growth but a net loss in Q2 2024. The company's focus on expanding its commercial organization and advancing clinical development indicates a strategic approach to drive future growth amidst challenges from generic competition.

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Q1 2023 total revenues were $62.5 million Vanda provides update on three upcoming regulatory submissions WASHINGTON , May 3, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the first quarter ended March 31, 2023. "The first quarter of 2023 was busy and challenging as we are preparing three regulatory submissions for bipolar disorder, insomnia and gastroparesis and, at the same time, defending our intellectual property," said Mihael H.

Vanda Pharmaceuticals Reports First Quarter 2023 Financial Results

WASHINGTON , May 2, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced its action against the federal government for the uncompensated taking and misuse of Vanda's trade secrets and confidential information. Vanda alleges that the U.S. Food and Drug Administration (FDA) improperly provided confidential details from Vanda's drug master files for its products, HETLIOZ® and Fanapt®, to generic drug manufacturers during the FDA's review of the manufacturers' Abbreviated New Drug Applications.

Vanda Pharmaceuticals Sues Federal Government for Misappropriation of Trade Secrets and Confidential Information

Conference Call and Webcast to Follow WASHINGTON , April 27, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the first quarter 2023 on Wednesday, May 3, 2023, after the market closes.  Vanda will host a conference call at 4:30 PM ET on Wednesday, May 3, 2023, during which management will discuss the first quarter 2023 financial results and other corporate activities.

Vanda Pharmaceuticals to Announce First Quarter 2023 Financial Results on May 3, 2023

WASHINGTON , March 28, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced a win in its jet lag FOIA litigation against the FDA. On March 27, 2023 a federal court granted final judgment in favor of Vanda in its Freedom of Information Act ("FOIA") case requesting records created by the Food and Drug Administration ("FDA") during its review of Vanda's application seeking approval of a new use for its drug, Hetlioz® (tasimelteon).

Vanda Prevails in Jet Lag Litigation Against the FDA

WASHINGTON , March 17, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the appointment of Tage Honoré, Ph.D., D.Sc. to its Board of Directors effective March 15, 2023.

Vanda Pharmaceuticals Appoints Dr. Tage Honoré to its Board of Directors

A solid earnings beat drove the company's share price upward.

Why Vanda Pharmaceuticals Stock Crawled Higher Today

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA ) Q4 2022 Earnings Conference Call February 8, 2023 4:30 AM ET Company Participants Kevin Moran - CFO Mihael Polymeropoulos - President, CEO and Chairman Timothy Williams - General Counsel Conference Call Participants Operator Ladies and gentlemen, thank you for standing by, and welcome to the Q4 2022 Vanda Pharmaceuticals Inc. Earnings Conference Call. I would now like to turn the call over to Kevin Moran, Vanda's Chief Financial Officer.

Vanda Pharmaceuticals Inc. (VNDA) Q4 2022 Earnings Call Transcript

Q4 2022 total revenues were $64.5 million Full year 2022 revenues were $254.4 million Vanda provides update on pipeline advancements and upcoming milestones WASHINGTON , Feb. 8, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the fourth quarter and full year ended December 31, 2022. "Our strong full year 2022 commercial performance positions Vanda well towards our objectives as we pursue a number of near term regulatory filings in bipolar I disorder, gastroparesis and insomnia," said Mihael H.

Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results

Conference Call and Webcast to Follow WASHINGTON , Feb. 1, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the fourth quarter and full year 2022 on Wednesday, February 8, 2023, after the market closes. Vanda will host a conference call at 4:30 PM ET on Wednesday, February 8, 2023, during which management will discuss the fourth quarter and full year 2022 financial results and other corporate activities.

Vanda Pharmaceuticals to Announce Fourth Quarter and Full Year 2022 Financial Results on February 8, 2023

Supplemental New Drug Application (sNDA) planned for 2023 WASHINGTON , Dec. 19, 2022 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today reported positive results in a Phase III clinical study of Fanapt® (iloperidone tablets), a novel atypical antipsychotic, in the treatment of acute manic and mixed episodes associated with bipolar I disorder in adults. Fanapt® is currently approved by the FDA for the treatment of schizophrenia in adults.

Fanapt® Shown to be Effective in Bipolar I Disorder in Phase III Clinical Study

WASHINGTON , Dec. 16, 2022 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today provided an update on its appeal of the recent HETLIOZ® ANDA litigation ruling. On December 14, 2022, Vanda appealed the December 13 th decision of the United States District Court for the District of Delaware in the HETLIOZ® ANDA litigation to the United States Court of Appeals for the Federal Circuit and requested an injunction prohibiting market entry by Teva Pharmaceuticals USA, Inc. (Teva) and Apotex Inc. (Apotex) while the appeal is pending.

Vanda Pharmaceuticals Provides an Update to HETLIOZ® ANDA Litigation Appeal: Federal Circuit grants motion to temporarily enjoin generic launch

WASHINGTON , Dec. 13, 2022 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today responded to the ruling in its HETLIOZ® ANDA Litigation. Vanda has brought several Hatch-Waxman lawsuits in the United States District Court for the District of Delaware against Teva Pharmaceuticals USA, Inc. (Teva) and Apotex Inc. (Apotex) asserting infringement of patents covering HETLIOZ® (tasimelteon) 20 mg capsules.

Vanda Pharmaceuticals Responds to Ruling in HETLIOZ® ANDA Litigation

WASHINGTON , Dec. 2, 2022 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today reported results in a Phase II clinical study of VQW-765, a novel small molecule alpha 7 nicotinic acetylcholine receptor (α7-nAChR) partial agonist, in the treatment of acute performance anxiety in social situations, such as public speaking. In clinical study VP-VQW-765-2201 (Study 2201), 230 volunteers with prior history of performance anxiety were randomized to receive a single dose of VQW-765 or placebo and were challenged with the standardized Trier Social Stress Test (TSST).

Vanda Pharmaceuticals Reports Results in a Phase II Clinical Study of VQW-765 in the Treatment of Acute Performance Anxiety

WASHINGTON , Nov. 8, 2022 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the following upcoming investor conferences in November 2022: The Stifel 2022 Healthcare Conference on Tuesday, November 15, 2022. A corporate presentation is scheduled for 10:20 a.m.

Vanda Pharmaceuticals Announces Participation at November 2022 Investor Conferences

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA ) Q3 2022 Earnings Conference Call November 2, 2022 4:30 PM ET Company Participants Kevin Moran - Senior Vice President & Chief Financial Officer Mihael Polymeropoulos - President & Chief Executive Officer Tim Williams - General Counsel Conference Call Participants Operator Good afternoon. My name is Abba and I will be your conference operator today.

Vanda Pharmaceuticals Inc. (VNDA) Q3 2022 Earnings Call Transcript

Vanda (VNDA) delivered earnings and revenue surprises of -40% and 8%, respectively, for the quarter ended September 2022. Do the numbers hold clues to what lies ahead for the stock?

Vanda Pharmaceuticals (VNDA) Lags Q3 Earnings and Revenue Estimates

Q3 2022 total revenues were $65.3 million Total revenues in the first nine months of 2022 were $189.9 million Vanda provides update on pipeline advancements and upcoming milestones WASHINGTON , Nov. 2, 2022 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the third quarter ended September 30, 2022. "We continue to focus on strong commercial execution, the advancement of our clinical pipeline and our upcoming regulatory milestones of the submissions of an NDA for tradipitant in gastroparesis and an sNDA for HETLIOZ® in insomnia," said Mihael H.

Vanda Pharmaceuticals Reports Third Quarter 2022 Financial Results

Conference Call and Webcast to Follow WASHINGTON , Oct. 26, 2022 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the third quarter 2022 on Wednesday, November 2, 2022, after the market closes.   Vanda will host a conference call at 4:30 PM ET on Wednesday, November 2, 2022, during which management will discuss the third quarter 2022 financial results and other corporate activities.

Vanda Pharmaceuticals to Announce Third Quarter 2022 Financial Results on November 2, 2022

From the commercialization front, Vanda Pharmaceuticals is taking prudent steps to boost Hetlioz and Fanapt sales. The company recently planted long-term growth via the OliPas partnership for ASO development.

Vanda: VPO-227 Advancement Signals More Upsides

WASHINGTON , Oct. 21, 2022 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for VPO-227 for the treatment of cholera. While the incidence of cholera in the U.S. is low, cholera is a widespread infectious diarrheal disease with estimated 1.4 to 4 million cases worldwide, resulting in 21,000 to 143,000 deaths annually.1 Many of these deaths occur in children, as diarrheal diseases are the second leading cause of death globally among children under 5 years of age.2 Cholera remains a major public health challenge and recognized unmet medical need despite decades-long public health efforts.

Vanda Pharmaceuticals Announces Orphan Drug Designation Granted for VPO-227, a Novel Candidate for the Treatment of Cholera

Vanda Pharmaceuticals is a stellar growth stock trading near its cash position. Despite the latest revenue trend aberration, Vanda is still set to post significant sales increase for Fiscal 2022.

Vanda Pharmaceuticals: What The Recent Partnership Entails

WASHINGTON , Sept. 29, 2022 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) and OliPass Corporation (OliPass) (KOSDAQ: 24460) today announced that they have entered into a research and development collaboration agreement to jointly develop a set of antisense oligonucleotide (ASO) molecules based on OliPass' proprietary modified peptide nucleic acids.

Vanda Pharmaceuticals and OliPass Announce Strategic Partnership to Develop Antisense Oligonucleotide Therapeutics

WASHINGTON , Sept. 7, 2022 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the notice of opportunity for an FDA hearing on Vanda's Supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) to treat jet lag disorder.

VANDA PHARMACEUTICALS ANNOUNCES NOTICE OF OPPORTUNITY FOR AN FDA HEARING ON THE sNDA FOR HETLIOZ® IN JET LAG DISORDER

Vanda (VNDA) delivered earnings and revenue surprises of -54.55% and 3.90%, respectively, for the quarter ended June 2022. Do the numbers hold clues to what lies ahead for the stock?

Vanda Pharmaceuticals (VNDA) Q2 Earnings and Revenues Miss Estimates

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA ) Q2 2022 Earnings Conference Call August 3, 2022 4:30 PM ET Company Participants Mihael H. Polymeropoulos - President & Chief Executive Officer Kevin Moran - Senior Vice President & Chief Financial Officer Conference Call Participants Chris Howerton - Jefferies Operator Thank you for standing by, and welcome to the Q2 2022 Vanda Pharmaceuticals, Inc. Earnings Call.

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