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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Vanda (VNDA) announces the FDA's approval of Fanapt for the acute treatment of bipolar I disorder in adults. The stock rises 30.4%.

Vanda (VNDA) Up on FDA Nod for Fanapt in Bipolar I Disorder

Vanda Pharmaceuticals (NASDAQ: VNDA ) stock is heading higher on Wednesday after the biopharmaceutical company got new approval from the Food and Drug Administration (FDA). This new approval covers the use of the company's Fanapt tablets as an acute treatment of manic or mixed episodes connected to bipolar I disorder in adults.

Why Is Vanda Pharmaceuticals (VNDA) Stock Up 33% Today?

Shares of Vanda Pharmaceuticals VNDA, -5.10% jumped 33% to $5.23 in post-market trading after the company said the Food and Drug Administration approved Fanapt to treat manic or mixed episodes associated with bipolar I disorder in adults.

Vanda Pharmaceuticals shares jump 30% after FDA approval of Fanapt for bipolar I disorder

The U.S. FDA approved Vanda Pharmaceuticals' drug to treat manic and mixed episodes associated with a type of bipolar disorder, the company said on Tuesday, marking the second approval for the treatment.

US FDA approves Vanda's drug for bipolar 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 /PRNewswire/ -- 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.

Vanda Pharmaceuticals' Fanapt® (iloperidone) Receives U.S. FDA Approval for the Acute Treatment of Bipolar I Disorder

NEW YORK , March 27, 2024 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Vanda Pharmaceutical Inc. ("Vanda" or the "Company") (NASDAQ: VNDA). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Vanda Pharmaceutical Inc. - VNDA

Vanda's (VNDA) supplemental new drug application seeking approval for Hetlioz to treat insomnia gets a complete response letter from the FDA.

Vanda (VNDA) Falls on FDA's CRL to Hetlioz sNDA for Insomnia

WASHINGTON , March 6, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that on March 4, 2024, it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) as part of its ongoing review of Vanda's supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) in the treatment of insomnia characterized by difficulties with sleep initiation. In July 2023, the FDA had assigned a Prescription Drug User Fee Act target date of March 4, 2024 for the completion of its review of the sNDA.

Vanda Pharmaceuticals Announces FDA Update for supplemental NDA for HETLIOZ® in the Treatment of Insomnia

Vanda Pharmaceuticals is trading materially below its holdings of cash and marketable securities (worth almost $7/share). Multiple FDA approvals, if forthcoming, in 2024 could prove to be material catalysts, perhaps highlighting that the company has operational assets beyond its cash. The market's current valuation of VNDA appears too pessimistic and a range of $5-10/share may be more reasonable, even assuming imperfect capital allocation.

Vanda Pharmaceuticals' Portfolio Likely Has Upside From 2024 Approvals, Underpinned By Cash

Vanda (VNDA) shares have started gaining and might continue moving higher in the near term, as indicated by solid earnings estimate revisions.

Earnings Estimates Moving Higher for Vanda (VNDA): Time to Buy?

Vanda Pharmaceuticals Inc. (VNDA) Q4 2023 Earnings Call Transcript

Full year 2023 revenues were $192.6 million PONVORY® acquisition completed in Q4 2023 and transition ongoing 3 FDA PDUFA target action dates in 2024 Ended 2023 with approximately $388 million in cash and cash equivalents WASHINGTON , Feb. 7, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the fourth quarter and full year ended December 31, 2023. "Despite significant external commercial and regulatory challenges, last year was a landmark year for Vanda, as we supported our commercial programs and, through a transformational deal, we added PONVORY® to our portfolio alongside Fanapt® and HETLIOZ®," said Mihael H.

Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results

Conference Call and Webcast to Follow WASHINGTON , Jan. 31, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the fourth quarter and full year 2023 on Wednesday, February 7, 2024, after the market closes.   Vanda will host a conference call at 4:30 PM ET on Wednesday, February 7, 2024, during which management will discuss the fourth quarter and full year 2023 financial results and other corporate activities.

Vanda Pharmaceuticals to Announce Fourth Quarter and Full Year 2023 Financial Results on February 7, 2024

WASHINGTON , Jan. 31, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to evaluate VTR-297 for the treatment of onychomycosis. Onychomycosis, or tinea unguium, is a fungal infection of the nail.

Vanda Pharmaceuticals Receives FDA Approval to Proceed with Investigational New Drug VTR-297 a Topical Antifungal Candidate for the Treatment of Onychomycosis

WASHINGTON , Jan. 30, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the United States District Court for the District of Columbia granted Vanda's motion for summary judgment on its claim against the United States Food and Drug Administration (FDA) for unlawfully delaying a hearing on the approvability of Vanda's supplemental new drug application (sNDA) for HETLIOZ® to treat jet lag disorder (Vanda Pharmaceuticals Inc. v. FDA, case no.

Court Orders FDA to Resolve Vanda Pharmaceuticals' Jet Lag Hearing Request by March 5, 2024

WASHINGTON , Jan. 25, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Patent and Trademark Office has issued a notice of allowance for its PONVORY® (ponesimod) patent application, number 17/962,968, covering methods for reducing clinical management events before or during the treatment of multiple sclerosis and methods for reinitiating treatment after missed doses. When issued, this patent is anticipated to expire on October 10, 2042.

Vanda Pharmaceuticals Announces a U.S. Patent Allowance for PONVORY® (ponesimod) in the U.S.

WASHINGTON , Jan. 25, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the publication of an article titled "The Efficacy of Tradipitant in Patients with Diabetic and Idiopathic Gastroparesis in Phase III Randomized Placebo-Controlled Clinical Trial" in the Clinical Gastroenterology and Hepatology Journal1 which follows a previously published study of tradipitant in the treatment of gastroparesis in 2021.2 The findings of this pivotal phase III study are included in the New Drug Application for tradipitant in the treatment of gastroparesis in adults submitted to the U.S. Food and Drug Administration (FDA) The FDA has set a Prescription Drug User Fee Act target action date of September 18, 2024 for its decision. References Carlin, J.

Vanda Pharmaceuticals announces the publication of an article on "The Efficacy of Tradipitant in Patients with Diabetic and Idiopathic Gastroparesis in Phase III Randomized Placebo-Controlled Clinical Trial" in the Clinical Gastroenterology and Hepatology

WASHINGTON , Jan. 23, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to evaluate VCA-894A for the treatment of a patient with Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), caused by cryptic splice site variants within the IGHMBP2 gene. CMT2S is a rare subtype of Charcot-Marie-Tooth disease (CMT), an inherited peripheral neuropathy for which there is no available treatment.

Vanda Pharmaceuticals Receives FDA Approval to Proceed with Investigational New Drug VCA-894A, a Novel Antisense Oligonucleotide Candidate for the Treatment of Charcot-Marie-Tooth Disease, Type 2S

WASHINGTON , Jan. 19, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the United States Court of Federal Claims in Washington, D.C. denied in part the government's motion to dismiss Vanda's claim against the United States for the Food and Drug Administration's (FDA) uncompensated taking of Vanda's trade secrets and confidential information (Vanda Pharmaceuticals Inc. v.

Federal Court Allows Vanda Pharmaceuticals' Lawsuit to Proceed Against the U.S. Food and Drug Administration

WASHINGTON , Jan. 17, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the publication of an article titled "Efficacy and Safety of Iloperidone in Bipolar Mania: A Double-Blind, Placebo-Controlled Study" in the Journal of Clinical Psychiatry.1 The findings of this pivotal study have been submitted to the U.S. Food and Drug Administration (FDA) as part of Vanda's supplemental New Drug Application for Fanapt® in the treatment of bipolar I disorder in adults. The FDA has set a Prescription Drug User Fee Act target action date of April 2, 2024 for its decision.

Vanda Pharmaceuticals announces the publication of Efficacy and Safety of Iloperidone in Bipolar Mania: A Double-Blind, Placebo-Controlled Study in the Journal of Clinical Psychiatry

WASHINGTON , Jan. 12, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) submitted a comment letter (here) on January 5, 2024, regarding the FDA's recently announced policy—by way of a draft guidance document—that substantially restricts drug manufacturers' ability to communicate truthful, non-misleading information about FDA-approved drugs. Communication of novel scientific findings and emerging therapies is crucial to inform healthcare providers about new treatment options that did not exist at the time of their medical training.

Vanda Pharmaceuticals Comments on FDA's Recently Announced Guidance on Communication with Health Care Professionals Regarding FDA-Approved Drugs

WASHINGTON , Jan. 4, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the J.P. Morgan Healthcare Conference in San Francisco, California on Tuesday, January 9, 2024.

Vanda Pharmaceuticals Announces Participation in the J.P. Morgan Healthcare Conference

A PDUFA date of September 18th, 2024 has been set by the FDA to review whether or not the tradipitant should be approved for gastroparesis. The global gastroparesis treatment market is projected to reach $7.19 billion by 2029. An sNDA for the review of HETLIOZ for the treatment of insomnia characterized by difficulties with sleep initiation has a PDUFA date of March 4th, 2024.

Vanda Pharmaceuticals: FDA Approvals On Deck In 2024 Makes This A Must Watch

WASHINGTON , Dec. 7, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has acquired U.S. and Canadian rights to PONVORY® (ponesimod) from Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson Company.

Vanda Pharmaceuticals Acquires U.S. and Canadian Rights to PONVORY® (ponesimod), a Selective S1P1R Modulator Approved for Patients with Relapsing Multiple Sclerosis

The FDA accepts Vanda's (VNDA) new drug application ("NDA") for tradipitant for treating the symptoms of gastroparesis. The company's shares rise in after-hours trading.

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