Welcome to our dedicated page for Vanda Pharma news (Ticker: VNDA), a resource for investors and traders seeking the latest updates and insights on Vanda Pharma stock.
About Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Inc. (VNDA) is a specialty biopharmaceutical company dedicated to the development and commercialization of innovative therapies for conditions with high unmet medical needs. Employing state-of-the-art research and development (R&D) techniques, Vanda focuses on addressing complex medical conditions such as sleep-wake disorders, schizophrenia, bipolar disorder, and multiple sclerosis, among others. With a robust clinical pipeline and a deep commitment to scientific excellence, Vanda leverages advanced technologies, including antisense oligonucleotides (ASOs), to create targeted treatments that improve the quality of life for patients around the globe.
Core Business Areas and Therapeutic Focus
At its core, Vanda specializes in translating intricate scientific research into commercially viable therapies. The company has successfully commercialized products such as HETLIOZ, which is used for treating Non-24-Hour Sleep-Wake Disorder and nighttime disturbances in Smith-Magenis Syndrome patients, and Fanapt, which addresses psychiatric conditions including schizophrenia. Vanda further diversifies its portfolio with products like PONVORY, aiming to meet critical market needs in multiple sclerosis and other inflammatory conditions. The company’s dedication to uncovering and addressing overlooked therapeutic areas illustrates its commitment to improving patient outcomes in challenging clinical landscapes.
Research and Development Excellence
Vanda’s strong emphasis on R&D underpins its innovative approach to drug development. The company’s pipeline includes both late-stage and early-stage assets that tackle disorders with few effective treatment options. Its strategic approach involves rigorous clinical trials, state-of-the-art biomarker research, and adaptive study designs that ensure safety and efficacy. By incorporating industry-specific practices and leveraging advanced molecular and genetic technologies, Vanda has established itself as a trusted name in specialty pharmaceuticals.
Global Commercialization and Market Presence
Commercially, Vanda maintains a significant presence in key markets, predominantly in the United States but also extending its footprint across Europe, Canada, and Israel. The company has built an efficient commercial infrastructure designed to support its diverse product portfolio. This infrastructure not only facilitates the launch of novel therapies but also enables the effective management of a complex sales and marketing operation, ensuring that products reach the patients who need them most.
Competitive Landscape and Industry Position
Operating in the competitive field of specialty pharmaceuticals, Vanda differentiates itself through a combination of clinical innovation, strategic product positioning, and a focus on high unmet medical needs. Its product portfolio is backed by scientific research published in peer-reviewed journals and a series of well-controlled clinical studies. Vanda’s commitment to scientific transparency and adherence to regulatory standards reinforces its reputation as an authoritative and trustworthy entity in the biopharmaceutical industry.
Expertise, Experience, and Trustworthiness (E-E-A-T)
Vanda Pharmaceuticals exemplifies the E-E-A-T principles through its extensive history of clinical research, regulatory diligence, and targeted therapeutic development. The company’s ability to integrate scientific discovery with practical commercial strategy is evidenced by its ongoing engagement in critical clinical trials and strategic partnerships. Investors and healthcare professionals alike recognize Vanda for its thoughtful approach to innovation, its proven expertise in navigating complex regulatory environments, and its commitment to advancing therapies that address significant unmet patient needs.
Conclusion
Overall, Vanda Pharmaceuticals Inc. stands as a highly specialized biopharmaceutical company that combines rigorous scientific research with a comprehensive commercialization strategy. Its focus on complex, high-need therapeutic areas, coupled with innovation in drug development and a strong global presence, positions the company as a key player in the specialty pharmaceuticals arena.
Vanda Pharmaceuticals (VNDA) announced its participation at the American Academy of Neurology (AAN) Annual Meeting in San Diego from April 5-9, 2025. The company will present a poster on April 9 showcasing data for VCA-894A, a novel therapeutic customized for a specific genetic mutation in Charcot-Marie-Tooth disease type 2S (CMT2S).
The presentation will highlight how VCA-894A demonstrated significant improvements in neuromuscular function using Hesperos' Human-on-a-Chip® model with patient-derived cells. Key improvements include reduced muscle fatigue and enhanced synaptic transmission between motor neurons and skeletal muscle myotubes.
The FDA has granted VCA-894A an orphan designation, and it is expected to be administered to the specific patient for whom it was developed. The experimental platform represents advancement in precision medicine, potentially enabling development of genetically-tailored treatments for unmet medical needs.
Vanda Pharmaceuticals (NASDAQ: VNDA) has submitted a New Drug Application (NDA) to the FDA for Bysanti™ (milsaperidone), targeting the treatments of acute bipolar I disorder and schizophrenia. The application is backed by multiple clinical studies evaluating the drug's efficacy and safety.
Bysanti™, a novel atypical antipsychotic, works by interacting with various neurotransmitter receptors including alpha-adrenergic, serotonin, and dopamine receptors in the brain. If approved, the drug could reach the US market by 2026, with potential exclusivity extending into the 2040s.
Additionally, Vanda has launched a Phase III clinical trial investigating Bysanti™ as a once-daily adjunctive treatment for major depressive disorder (MDD), with results anticipated in 2026.
Vanda Pharmaceuticals (VNDA) has published research on a novel antisense oligonucleotide (ASO) therapeutic, VCA-894A, developed for treating a patient with Charcot-Marie-Tooth disease Type 2S (CMT2S). The treatment targets a specific variant of the IGHMBP2 gene.
CMT2S is an inherited neuromuscular disorder causing progressive muscle weakness and motor function loss, with a prevalence of less than 1 in 1,000,000 worldwide. VCA-894A has shown significant improvements in neuromuscular function in testing, including reduced muscle fatigue and improved synaptic transmission between motor neurons and skeletal muscle myotubes.
The FDA has granted VCA-894A an orphan designation, and it is expected to be administered to the specific patient for whom it was developed. The experimental platform represents a breakthrough in precision medicine, potentially enabling the development of personalized treatments for rare genetic diseases.
Vanda Pharmaceuticals (VNDA) reported Q4 2024 total revenues of $53.2 million, up 17% year-over-year, with Fanapt® sales reaching $26.6 million (+18% YoY). Full-year 2024 revenues totaled $198.8 million, a 3% increase from 2023. The company posted a Q4 net loss of $4.9 million and a full-year net loss of $18.9 million.
Looking ahead, Vanda projects 2025 revenue between $210-250 million and targets psychiatry portfolio revenue exceeding $750 million by 2030. Key regulatory milestones include MAA submissions for Fanapt® and HETLIOZ® in Q4 2024, upcoming BysantiTM NDA submission in Q1 2025, and imsidolimab BLA submission planned for 2025.
The company's cash position stands at $374.6 million as of December 31, 2024, representing a decrease of $13.6 million from year-end 2023.
Vanda Pharmaceuticals (Nasdaq: VNDA) has announced it will release its fourth quarter and full year 2024 financial results on Thursday, February 13, 2025, after market close. The company will host a conference call at 4:30 PM ET on the same day to discuss the financial results and other corporate activities.
Participants can join the conference call by dialing 1-800-715-9871 (domestic) or 1-646-307-1963 (international) using passcode 2881765. The call will be simultaneously broadcast and archived on Vanda's website. A replay will be available from 8:30 PM ET on February 13 until February 20, 2025, at 11:59 PM ET.
Vanda Pharmaceuticals (VNDA) and AnaptysBio announced an exclusive global license agreement for imsidolimab, an IL-36R antagonist that has completed two Phase 3 trials for Generalized Pustular Psoriasis (GPP). Under the agreement, Vanda will pay $15 million upfront ($10M payment plus $5M for drug supply) and will receive exclusive global rights to develop, manufacture, and commercialize imsidolimab.
The drug has successfully completed GEMINI-1 and GEMINI-2 global Phase 3 trials for GPP, a rare skin disorder affecting between 1.76 and 124 patients per million people worldwide. Vanda plans to prepare BLA and MAA applications for US and EU markets in 2025. AnaptysBio is eligible for up to $35 million in future regulatory and sales milestones, plus a 10% royalty on net sales.
Vanda Pharmaceuticals (VNDA) has accepted the FDA's opportunity for a hearing regarding its New Drug Application (NDA) for tradipitant in gastroparesis treatment. The company submitted the NDA in September 2023, which was rejected via a Complete Response Letter in September 2024. The FDA cited insufficient evidence of efficacy despite positive results from Study 1 showing significant improvement in nausea severity.
The clinical program included two placebo-controlled studies and one open-label study. Study 1 (152 patients) demonstrated statistically significant improvement in nausea at week 4, while Study 2 (201 patients) showed numerical but not statistically significant improvements versus placebo. Over 1,000 people have been treated with tradipitant, with some receiving treatment for more than a year through an expanded access program.
Vanda disagrees with the FDA's assessment and argues that the evidence meets the statutory standard of 'substantial evidence' required for approval. No new drug has been approved for gastroparesis in over 40 years.
Vanda Pharmaceuticals (NASDAQ: VNDA) has issued a letter to FDA Commissioner Robert M. Califf addressing concerns over the agency's rejection of its New Drug Application (NDA) for tradipitant, a treatment for gastroparesis symptoms. The letter follows a Complete Response Letter (CRL) received on September 18, 2024, which denied approval for the drug.
The company criticizes the FDA's review process, highlighting several issues including: the lack of response from Dr. Nikolov to their concerns about the CRL, the denial of their request for an Advisory Committee meeting, and what they describe as a 'disturbing pattern of conduct' at the FDA. The letter points out a significant decline in Advisory Committee meetings, from 55% of drug applications in 2010 to 6% in 2021.
Vanda argues that the FDA's current policies and practices need realignment with scientific evidence and law, particularly questioning the Commissioner's stance on only overruling civil servants' decisions in cases of 'corruption' or 'temporary insanity.'
Vanda Pharmaceuticals (VNDA) has received FDA Orphan Drug Designation for VGT-1849A, a selective antisense oligonucleotide-based JAK2 inhibitor designed to treat polycythemia vera (PV). PV is a rare blood cancer affecting approximately 1 in 2000 Americans, characterized by excessive red blood cell production.
VGT-1849A specifically targets JAK2, potentially offering advantages over current treatments like Jakafi®, Inrebic®, Ojjaara®, and Vonjo® which lack selective targeting. This specificity could reduce infection risks and toxic effects associated with broader JAK inhibition. The treatment represents Vanda's second precision medicine therapeutic, following VCA-894A for Charcot-Marie-Tooth disease.
Vanda Pharmaceuticals (VNDA) has announced its participation in two major investor conferences in November 2024. The company will deliver a corporate presentation at the Stifel 2024 Healthcare Conference on November 19 at 9:45 a.m. ET, followed by a fireside chat at the Jefferies 2024 London Healthcare Conference on November 21 at 11:30 a.m. GMT. Both events will be accessible live through Vanda's corporate website, with archived recordings available for approximately 30 days afterward.
FAQ
What is the current stock price of Vanda Pharma (VNDA)?
What is the market cap of Vanda Pharma (VNDA)?
What is the primary focus of Vanda Pharmaceuticals?
What therapeutic areas does Vanda address?
How does Vanda generate revenue?
What distinguishes Vanda's approach in drug development?
What role does clinical research play in Vanda’s business model?
How does Vanda maintain its competitive edge?
In which markets does Vanda operate?
How does Vanda demonstrate its expertise and trustworthiness?
