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Vanda Pharmaceuticals Inc. - VNDA STOCK NEWS

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

Vanda Pharmaceuticals Inc., traded under the symbol VNDA on Nasdaq, is a specialty biopharmaceutical company dedicated to the development and commercialization of innovative therapies. Vanda's primary focus is on addressing high unmet medical needs to improve the lives of patients. The company's commercial portfolio includes HETLIOZ for Non-24-Hour Sleep-Wake Disorder and nighttime sleep disturbances in Smith-Magenis Syndrome, and Fanapt for schizophrenia. Recently added to its portfolio is PONVORY, a treatment for multiple sclerosis.

Other promising products in Vanda's pipeline include VHX-896, ASO Molecules, VQW-765, Tradipitant (in clinical studies for gastroparesis and motion sickness), and VTR-297. Vanda's robust R&D efforts are highlighted by substantial advancements, such as the initiation of clinical programs in conditions like depression, psoriasis, ulcerative colitis, and pediatric insomnia.

In recent financial news, Vanda reported a net loss of $4.1 million for Q1 2024, a shift from a net income of $3.3 million in Q1 2023. Despite this, the company maintains a strong cash position and expects significant growth from upcoming milestones, including the launch of Fanapt in acute bipolar I disorder and PONVORY in multiple sclerosis.

Recently, Vanda made headlines with the FDA approval of tradipitant for preventing vomiting induced by motion sickness, and the commencement of a comprehensive marketing program for PONVORY following its acquisition from a Johnson & Johnson company. Additional corporate activities involve evaluating unsolicited acquisition proposals, indicating a strategic interest in Vanda’s innovative portfolio.

For more detailed information, investors can visit www.vandapharma.com and follow Vanda on social media platforms.

News

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

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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Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results

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

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

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

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

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

Rhea-AI Summary
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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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 Journal

Rhea-AI Summary
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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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

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

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Vanda Pharmaceuticals Inc. (VNDA) has received a partial denial from the United States Court of Federal Claims for the FDA's uncompensated taking of Vanda's trade secrets and confidential information. The claim filed in May 2023 seeks compensation for the FDA's improper communication and disclosure of trade secrets to certain generic drug manufacturers. The Court's decision on January 18, 2024, allows Vanda's takings claim to move forward, with the company now intending to engage in discovery to support its claims.
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FAQ

What is the current stock price of Vanda Pharmaceuticals (VNDA)?

The current stock price of Vanda Pharmaceuticals (VNDA) is $5.09 as of November 22, 2024.

What is the market cap of Vanda Pharmaceuticals (VNDA)?

The market cap of Vanda Pharmaceuticals (VNDA) is approximately 290.4M.

What does Vanda Pharmaceuticals Inc. specialize in?

Vanda Pharmaceuticals Inc. specializes in developing and commercializing novel therapies for high unmet medical needs.

Which products are currently in Vanda's commercial portfolio?

Vanda's commercial portfolio includes HETLIOZ, Fanapt, and PONVORY.

What is HETLIOZ used for?

HETLIOZ is used to treat Non-24-Hour Sleep-Wake Disorder and nighttime sleep disturbances in Smith-Magenis Syndrome.

What is the latest financial update from Vanda?

Vanda reported a net loss of $4.1 million for Q1 2024, shifting from a net income of $3.3 million in Q1 2023.

What significant milestones does Vanda expect in the near future?

Upcoming milestones include the launch of Fanapt in acute bipolar I disorder and PONVORY in multiple sclerosis.

What recent product approval has Vanda received?

Vanda received FDA approval for tradipitant for preventing vomiting induced by motion sickness.

What is PONVORY, and what does it treat?

PONVORY is a treatment for multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

What recent corporate actions has Vanda undertaken?

Vanda is evaluating unsolicited acquisition proposals and has initiated comprehensive marketing for PONVORY.

How can investors access Vanda’s financial results conference call?

Investors can participate by dialing 1-800-715-9871 (domestic) or 1-646-307-1963 (international) with passcode 2594340, or visit Vanda's website.

Where can I find more information about Vanda Pharmaceuticals?

More information can be found on Vanda's official website, www.vandapharma.com, and their social media platforms.

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Vanda Pharmaceuticals Inc.

Nasdaq:VNDA

VNDA Rankings

#3581 Ranked by Market Cap
N/A Ranked by Dividends

VNDA Stock Data

290.37M
56.47M
3.16%
78.38%
6.41%
Biotechnology
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