Key Takeaways VNDA surged after tradipitant cut nausea and vomiting rates in a phase II Wegovy side-effect study.The therapy halved vomiting versus placebo and eased significant nausea with no new safety issues.Vanda plans to initiate a phase III program in 2026 to advance tradipitant as an adjunct therapy.Shares of Vanda Pharmaceuticals (VNDA) rallied 21.6% on Tuesday after the company reported positive top-line results from a mid-stage study evaluating tradipitant for the prevention of nausea and vomiting ...

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) on Monday released topline results from its randomized controlled clinical study (VP-VLY-686-2601) evaluating tradipitant to prevent nausea and vomiting induced by Wegovy.VNDA is surging to new heights today. See the full breakdown hereThe trial studied 116 healthy overweight or obese adults.Novo Nordisk A/S’ (NYSE:NVO) Wegovy (semaglutide) is a GLP-1 receptor agonist for overweight and obese adults.GLP-1 drugs are associated with early discontinuations due to gastro ...

Core Insights - Vanda Pharmaceuticals has announced positive topline results from a clinical study of tradipitant, indicating its potential as a key adjunct in the over $50 billion global GLP-1 agonist market [1][4]. Study Results - The study showed that only 29.3% of participants treated with tradipitant experienced vomiting compared to 58.6% in the placebo group, achieving a 50% relative reduction (p=0.0016) [2][4]. - The secondary endpoint was also met, with 22.4% of the tradipitant group experiencing vomiting and significant nausea, versus 48.3% in the placebo group (p=0.0039) [2][4]. Safety Profile - Tradipitant exhibited a favorable safety profile, consistent with previous studies, with no new safety signals reported [3][4]. Market Implications - The efficacy of tradipitant in reducing nausea and vomiting could significantly improve adherence to GLP-1 agonist treatments, which currently face a 30-50% discontinuation rate due to gastrointestinal side effects [5][6]. - The global GLP-1 agonist market is projected to exceed $50 billion, highlighting the potential financial impact of tradipitant's success [4][5]. Future Development - Vanda plans to initiate a Phase III program for tradipitant in the first half of 2026, aiming for regulatory approval to address the unmet need in managing GLP-1 induced nausea and vomiting [7][9].

Vanda Pharmaceuticals Conference Call Summary Company Overview - Vanda Pharmaceuticals is a leading global biopharmaceutical company focused on innovating to enhance people's happiness [2][3] - The company has three commercialized products: - **Fanapt**: Approved for bipolar disorder and schizophrenia in the U.S. - **Hetlioz**: Approved for non-24-hour sleep-wake disorder and nighttime sleep disturbances in Smith-Magenis Syndrome in both adults and pediatric populations, with approvals in Europe as well [2][3] - **Ponvory**: Approved for multiple sclerosis, acquired from Johnson & Johnson at the end of 2023 [3] Financial Position - As of Q3 2025, Vanda has approximately $294 million in cash and no debt [3] - 2025 revenue guidance is set between $210 million and $230 million, with Q3 2025 revenue reported at $56.3 million [12][13] Product Pipeline and Regulatory Updates - **Fanapt**: - Pursuing FDA approval for **Basanti**, the active metabolite of Fanapt, with a PDUFA target action date of February 21, 2026 [3][10] - Phase three program for major depressive disorder (MDD) expected to yield results in 2026 [4][10] - Long-acting injectable formulation of Fanapt is in phase three trials [11] - **Hetlioz**: - Re-review of the jet lag supplemental new drug application (SNDA) with an FDA decision expected by January 7, 2026 [4][10] - Pursuing additional indications for Hetlioz, including jet lag and maintaining market share against generics [6][7] - **Ponvory**: - Commercial launch is progressing well, with increased patient demand noted [7][8] - Ongoing phase three programs for psoriasis and ulcerative colitis [12] - **Tradipitant**: - Upcoming PDUFA date for motion sickness on December 30, 2025 [9][12] - Phase two study for nausea in patients taking GLP-1 medications is underway, with results expected in Q4 2025 [9][46] - **Imsidolumab**: - Biologics License Application (BLA) for generalized pustular psoriasis (GPP) expected to be submitted by the end of the year [10] Strategic Focus - Vanda aims to grow revenue organically through existing products and through potential business development opportunities [5] - Focus on increasing access and affordability for patients while engaging directly with consumers [5] Market Dynamics and Competitive Landscape - The antipsychotic market is evolving with new entrants like Kobenphy, which presents both opportunities and challenges [25][26] - The treatment landscape remains promotionally sensitive, with a high switch rate among patients seeking effective medications [27][28] Upcoming Milestones and Expectations - The company is optimistic about the upcoming PDUFA dates and the potential for positive results in ongoing trials [20][32] - The MDD trial is seen as a significant opportunity, with a large addressable market [34][35] - The motion sickness and jet lag markets are expected to be driven by consumer demand, with potential insurance coverage as well [38][40] Conclusion - Vanda Pharmaceuticals is well-positioned with a strong financial foundation and a robust pipeline of products and regulatory submissions. The company is focused on maximizing the potential of its existing products while navigating the competitive landscape and addressing unmet medical needs in various therapeutic areas.

Financial Data and Key Metrics Changes - Total net product sales for Q3 2025 reached $56.3 million, an 18% increase year over year, driven by a 31% increase in Fanapt sales and a 35% growth in prescriptions [5][22] - For the first nine months of 2025, total revenues were $158.9 million, a 9% increase compared to $145.6 million for the same period in 2024 [17] - The net loss for the first nine months of 2025 was $79.3 million, compared to a net loss of $14 million for the same period in 2024 [19] Business Line Data and Key Metrics Changes - Fanapt net product sales for Q3 2025 were $31.2 million, a 31% increase compared to $23.9 million in Q3 2024 [22][23] - Helios net product sales were $18 million for Q3 2025, a 1% increase compared to $17.9 million in Q3 2024 [25] - PONVORY net product sales were $7 million for Q3 2025, a 20% increase compared to $5.9 million in Q3 2024 [27] Market Data and Key Metrics Changes - Fanapt total prescriptions increased by 35% compared to Q3 2024 and 11% compared to Q2 2025 [24] - Helios continues to retain the majority of market share despite generic competition for over two and a half years [18] - PONVORY has shown an increase in underlying patient demand for the second consecutive quarter [36] Company Strategy and Development Direction - The company is investing strategically in its commercial infrastructure to support long-term market leadership and future commercial launches [6][10] - The company aims to achieve total revenues from Fanapt, Helios, and PONVORY of between $210 million and $230 million for 2025 [37] - The company expects to have six products commercially available in 2026, including tradipitant and Visanti [36] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the collaborative framework with the FDA and the potential for tradipitant approval by December 30, 2025 [44] - The company anticipates continued growth in Fanapt revenue, driven by the expanded sales force and increased market presence [37][61] - Management noted that Helios revenue can be variable from quarter to quarter, depending on customer purchasing patterns [60] Other Important Information - The company recorded a significant increase in operating expenses, primarily driven by higher SG&A and R&D expenses related to commercial launches [20][32] - Cash and cash equivalents as of September 30, 2025, were $293.8 million, a decrease of $80.9 million compared to December 31, 2024 [21] Q&A Session Summary Question: Comments on FDA interactions and potential approval timelines for tradipitant - Management is optimistic about the tradipitant review and expects a decision by December 30, 2025, with no efficacy issues raised so far [44][45] Question: Future growth expectations for PONVORY - Management indicated that underlying patient demand for PONVORY has increased, and they expect this trend to continue as the sales force is fully staffed [50][51] Question: Guidance change and its implications - The guidance reflects strong Fanapt revenue growth, but Helios revenue may vary based on customer purchasing patterns [60][61] Question: Engagement with the FDA regarding Visanti - Management reported positive interactions with the FDA regarding Visanti, with no issues raised on efficacy and safety [63] Question: Marketing strategy for upcoming product launches - The company is developing a consumer-centric marketing strategy for tradipitant and Helios, focusing on brand awareness and concierge services [69]

Core Insights - Vanda Pharmaceuticals reported strong commercial execution in Q3 2025, with total net product sales reaching $56.3 million, an 18% increase year-over-year, driven by a 31% increase in Fanapt sales and a 35% growth in prescriptions [2][7] - The company is advancing its pipeline with multiple near-term regulatory milestones, including the NDA for tradipitant and Bysanti, both under FDA review, and the anticipated submission of the imsidolimab BLA [2][6] Financial Highlights - In Q3 2025, Vanda reported a net loss of $22.6 million, compared to a net loss of $5.3 million in Q3 2024, with diluted net loss per share at $0.38 [4][7] - For the first nine months of 2025, the net loss was $79.3 million, compared to $14.0 million in the same period of 2024, with diluted net loss per share at $1.35 [5][7] Operational Highlights – Commercial - Fanapt net product sales increased by 31% to $31.2 million in Q3 2025 compared to Q3 2024, while HETLIOZ sales were stable at $18.0 million, a 1% increase [7][6] - The direct-to-consumer campaign launched in Q1 2025 has significantly improved brand awareness for Fanapt and PONVORY [7] Operational Highlights – Regulatory & Clinical Development - The NDA for tradipitant for motion sickness is under FDA review with a PDUFA target action date of December 30, 2025, and the Bysanti NDA for bipolar I disorder and schizophrenia has a PDUFA target action date of February 21, 2026 [6][7] - A clinical study of tradipitant in preventing vomiting induced by Wegovy is complete, with results expected in Q4 2025 [7]

Core Viewpoint - Vanda Pharmaceuticals has established a collaborative framework with the FDA to resolve disputes regarding its drugs HETLIOZ and tradipitant, which includes expedited reviews and temporary pauses in ongoing litigation [1][3]. Summary by Relevant Sections Agreement with FDA - Vanda Pharmaceuticals has agreed on a collaborative framework with the FDA to address disputes related to HETLIOZ (tasimelteon) and tradipitant [1]. - The FDA will conduct an expedited re-review of the partial clinical hold on tradipitant for motion sickness by November 26, 2025, and continue its review of the New Drug Application (NDA) with a target action date of December 30, 2025 [3]. Drug Applications and Reviews - The FDA will also expedite the re-review of Vanda's supplemental NDA for HETLIOZ for jet lag disorder by January 7, 2026, focusing on sleep-related aspects [3]. - Vanda and the FDA will seek a temporary pause in ongoing administrative proceedings related to tradipitant for gastroparesis until January 7, 2026 [3]. Legal Actions - Vanda will dismiss its lawsuits challenging the FDA's practices regarding drug application timelines and the partial clinical hold on tradipitant [3].

Financial Data and Key Metrics Changes - For the full year 2025, the company projects total revenues between $210 million and $250 million, with a midpoint of $230 million [23] - In the second quarter of 2025, the company reported revenue of $52.6 million, with net product sales from Fanapt at $29.3 million, Hetlioz at $16.2 million, and Ponvory at $7.1 million [23] - For the six months ended June 30, 2025, total revenue was approximately $103 million, with Fanapt being the lead revenue generator at approximately $53 million [23] - Operating expenses for the same period were approximately $182 million, resulting in a net loss of approximately $57 million [23] - The company ended the second quarter with approximately $325 million in cash and no debt [4][24] Business Line Data and Key Metrics Changes - Fanapt has seen significant prescription growth, reaching approximately 2,300 TRXs per week in mid-August 2025, compared to 1,300 to 1,400 TRXs per week around the same time last year [5] - New-to-brand prescriptions for Fanapt increased to about 240 NBRXs per week recently, up from about 40 NBRXs per week at the same time last year [5] - Hetlioz continues to face revenue erosion due to generic competition but maintains the majority of its patient population [6][7] - Ponvory, acquired from Johnson & Johnson, has shown higher patient demand in the second quarter of 2025 compared to the first quarter post-acquisition [9] Market Data and Key Metrics Changes - The company is focused on expanding its commercial footprint in the U.S. for Fanapt, increasing its sales representatives from approximately 150 to about 300 [4] - The company is pursuing FDA approval for Bysanti, with a PDUFA date set for February 21, 2026, and is also working on a clinical program for major depressive disorder [5][11] Company Strategy and Development Direction - The company aims to increase revenue both organically through existing products and through business development opportunities, as evidenced by the acquisition of Ponvory and in-licensing of imsidolumab [9][10] - The strategic focus includes advancing the pipeline with upcoming regulatory milestones that could increase the number of commercialized products from three to potentially six by the end of next year [10] - The company is committed to enhancing patient access and affordability for its medications while engaging directly with consumers [10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming regulatory milestones and the potential for increased commercial presence [10] - The company remains focused on retaining market share for Hetlioz despite generic competition and is pursuing additional indications for the product [11] - Management highlighted the significant unmet medical need for gastroparesis and the potential market opportunity for tradipitant if approved [17] Other Important Information - The company has a robust pipeline with several products at various stages of development, including tradipitant for gastroparesis and motion sickness, with PDUFA dates approaching [12][16] - The company is also pursuing additional treatments for Ponvory in ulcerative colitis and psoriasis [12] Q&A Session Summary Question: What is the expected revenue for 2025? - The company projects total revenues between $210 million and $250 million for 2025, with a midpoint of $230 million [23] Question: How is the commercial launch of Ponvory progressing? - The company noted that patient demand for Ponvory in the second quarter was higher than in the first quarter post-acquisition, indicating positive momentum [9] Question: What are the plans for Hetlioz in light of generic competition? - Management stated that they are focused on retaining market share and pursuing additional indications for Hetlioz, particularly in the Smith-Magenis syndrome market [11]

Core Viewpoint - Vanda Pharmaceuticals Inc. is facing delays from the FDA regarding the hearing on the approvability of tradipitant for gastroparesis, with the FDA attributing the delay to recent staff reductions, which Vanda disputes as a valid excuse [1][2][3]. Group 1: FDA Delays and Accountability - The FDA has indicated that a reduction in force on April 1 is partially responsible for delaying the recommendation on Vanda's hearing request by at least six months [2]. - Commissioner Dr. Martin Makary has stated that the cuts did not affect scientists or reviewers, raising questions about the validity of the FDA's claims regarding the delay [2][3]. - Vanda argues that the FDA has a history of denying hearing requests for new drug approvability over the past decade, suggesting systemic issues within the agency [3][4]. Group 2: Calls for Change - Vanda urges Commissioner Makary to intervene and restore legal adherence at the FDA, asserting that the culture of delay is not due to targeted reductions in force [5]. - The company emphasizes the need for "radical transparency and common sense" in the FDA's operations, as stated by both Commissioner Makary and Secretary Kennedy [5]. - Vanda's leadership calls for the FDA and DOJ to stop obstructing innovation and to focus on improving decision-making processes [6]. Group 3: Company Overview - Vanda Pharmaceuticals Inc. is a global biopharmaceutical company dedicated to developing innovative therapies to meet significant medical needs and enhance patient lives [7].