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Vanda Pharmaceuticals Inc - VNDA STOCK NEWS

Welcome to our dedicated news page for Vanda Pharmaceuticals (Ticker: VNDA), a resource for investors and traders seeking the latest updates and insights on Vanda Pharmaceuticals.

Our selection of high-quality news articles is accompanied by an expert summary from Rhea-AI, detailing the impact and sentiment surrounding the news at the time of release, providing a deeper understanding of how each news could potentially affect Vanda Pharmaceuticals's stock performance. The page also features a concise end-of-day stock performance summary, highlighting the actual market reaction to each news event. The list of tags makes it easy to classify and navigate through different types of news, whether you're interested in earnings reports, stock offerings, stock splits, clinical trials, fda approvals, dividends or buybacks.

Designed with both novice traders and seasoned investors in mind, our page aims to simplify the complex world of stock market news. By combining real-time updates, Rhea-AI's analytical insights, and historical stock performance data, we provide a holistic view of Vanda Pharmaceuticals's position in the market.

Rhea-AI Summary
Vanda Pharmaceuticals' Fanapt® Receives FDA Approval for Bipolar I Disorder Treatment, Expanding Commercial Opportunities
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End-of-Day
29.16%
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Rhea-AI Summary
Vanda Pharmaceuticals Inc. received a Complete Response Letter (CRL) from the FDA regarding its supplemental New Drug Application (sNDA) for HETLIOZ® in treating insomnia. The FDA identified deficiencies, leading to the rejection of the sNDA in its current form.
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-5.56%
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Rhea-AI Summary
Vanda Pharmaceuticals Inc. (VNDA) announced financial and operational results for the fourth quarter and full year ended December 31, 2023. Despite significant challenges, they supported their commercial programs and added PONVORY® to their portfolio alongside Fanapt® and HETLIOZ®. They advanced their clinical development pipeline with three NDA and sNDA submissions for insomnia, bipolar disorder, and gastroparesis, and are committed to advancing their clinical development pipeline and strengthening their commercial presence with innovative products.
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End-of-Day
11.81%
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Vanda Pharmaceuticals Inc. received a notification from the FDA regarding the ongoing review of its supplemental New Drug Application for HETLIOZ. The FDA identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. Vanda believes that the timing of the FDA's communication is part of an ongoing violation of the FDCA. The company is also challenging the FDA's approvals of several generic versions of HETLIOZ, which have been marketed since 2023.
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-4.41%
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Vanda Pharmaceuticals Inc. (VNDA) will release its Q4 and full year 2023 results on February 7, 2024. The company will host a conference call to discuss the financial results and corporate activities. Investors can participate via phone or webcast, with a replay available until February 14, 2024.
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End-of-Day
3.61%
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Vanda Pharmaceuticals Inc. (VNDA) has received FDA approval for the Investigational New Drug (IND) application to evaluate VTR-297 for the treatment of onychomycosis, a common fungal infection of nails. VTR-297 is a small molecule histone deacetylase (HDAC) inhibitor, and the new treatment is a significant milestone in developing potential therapies for this disorder. The current therapies for onychomycosis include topical agents JUBLIA® (efinaconzole), KERYDIN® (tavaborole), and PENLAC® (ciclopirox). This is the first FDA approval for a new onychomycosis treatment since 2014.
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-1.37%
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Vanda Pharmaceuticals Inc. (VNDA) won a motion for summary judgment against the FDA for unlawfully delaying the approval of HETLIOZ® to treat jet lag disorder. The court ordered the FDA to resolve the sNDA or commence a hearing by March 5, 2024.
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-3.95%
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Vanda Pharmaceuticals Inc. (VNDA) has received a notice of allowance for its PONVORY® patent application, covering methods for reducing clinical management events before or during the treatment of multiple sclerosis. Vanda intends to list this patent in the U.S. FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations. PONVORY® is approved by the U.S. FDA and Health Canada to treat adults with relapsing forms of multiple sclerosis.
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-1.06%
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Vanda Pharmaceuticals Inc. (VNDA) announced the publication of a pivotal phase III study on the efficacy of tradipitant in treating gastroparesis in adults. The study, published in the Clinical Gastroenterology and Hepatology Journal, follows a previous study in 2021. The FDA has set a decision date for September 18, 2024, for the New Drug Application for tradipitant.
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3.27%
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Vanda Pharmaceuticals Inc. announced that the FDA has approved the Investigational New Drug application to evaluate VCA-894A for the treatment of Charcot-Marie-Tooth disease, axonal, type 2S. This rare subtype of CMT has no available treatment, and the estimated prevalence of the CMT2S variant is less than 1 in 1,000,000 worldwide. VCA-894A is a novel antisense oligonucleotide that specifically targets a cryptic splice site variant within the IGHMBP2 gene, which plays a pivotal role in the manifestation of CMT2S. The treatment aims to enable personalized medicine and modulate gene expression for rare diseases.
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End-of-Day
-2.11%
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Vanda Pharmaceuticals Inc

Nasdaq:VNDA

VNDA Rankings

VNDA Stock Data

246.26M
52.05M
5.32%
92.21%
5.22%
Pharmaceutical Preparation Manufacturing
Manufacturing
Link
US
Washington

About VNDA

vanda is a specialty pharmaceutical company focused on the development and commercialization of novel therapies to address high unmet medical needs and improve the lives of patients.