Core Viewpoint - B. Riley has raised the price target for Vanda Pharmaceuticals (VNDA) to $14 from $11, maintaining a Buy rating, following the FDA's approval of Nereus for motion sickness-induced vomiting prevention, indicating a positive outlook for the company as it is seen as an "ongoing turnaround story" [1] Summary by Category Company Performance - The FDA approval of Nereus is expected to unlock over $100 million in peak revenue for Vanda Pharmaceuticals [1] - The approval is also significant for the potential approval of tradipitant, which is related to GLP-1 induced nausea [1] Market Position - Vanda Pharmaceuticals is currently trading at an "excessive discount" as it approaches two more potential approvals within the next 12 months [1]

Several healthcare and biotech names posted notable gains in Thursday's after-hours session, driven by clinical updates, earnings results, and regulatory developments.Sensei Biotherapeutics Inc. (SNSE) soared 62.9% to $17.20 after hours, extending momentum from its 21.4% rise at the close. The company did not release fresh updates on Thursday, but last month reported a narrower third-quarter net loss of $4.6 million compared with $7.3 million a year earlier. Sensei ended September with $25.0 million in cas ...

Core Insights - The U.S. FDA has lifted the partial clinical hold on Vanda Pharmaceuticals' protocol for tradipitant, allowing for an increase in the maximum number of doses administered in clinical studies [1][4] - This decision follows a formal dispute resolution request by Vanda and an expedited re-review by the FDA, which recognized motion sickness as an acute condition [2][3] - The ongoing review of the New Drug Application (NDA) for tradipitant is on track, with a target action date of December 30, 2025, potentially marking the first new treatment for motion sickness in over 40 years [4] Company Overview - Vanda Pharmaceuticals is a global biopharmaceutical company focused on developing innovative therapies to meet high unmet medical needs [5] - Tradipitant, a neurokinin-1 receptor antagonist licensed from Eli Lilly, is in clinical development for various indications, including motion sickness and nausea prevention [6]

Core Insights - Vanda Pharmaceuticals is undergoing a re-review process with the FDA regarding the partial clinical hold on tradipitant for motion sickness, with a new target completion date set for December 5, 2025 [1][6] - The New Drug Application (NDA) for tradipitant, aimed at preventing vomiting induced by motion, is progressing as scheduled, with a target action date of December 30, 2025 [2][6] - Tradipitant is a neurokinin-1 receptor antagonist developed by Vanda, which is in clinical development for multiple indications, including motion sickness [4] Group 1: FDA Review Process - The FDA is conducting an expedited re-review of the partial clinical hold on tradipitant, with the original completion date extended to accommodate recent personnel changes [1] - The NDA review for tradipitant continues on schedule, with the FDA having issued comments on the proposed labeling [2][6] Group 2: Product Development - Tradipitant is being developed for various indications, including motion sickness and nausea prevention related to GLP-1 receptor agonists [4] - Vanda aims to potentially deliver the first new pharmacologic treatment for motion sickness in over 40 years [2]

Core Insights - Vanda Pharmaceuticals' shares increased by 21.6% following positive results from a mid-stage study of tradipitant, aimed at preventing nausea and vomiting caused by Novo Nordisk's Wegovy in overweight and obese adults [1][8] Study Details - The phase II study involved 116 healthy overweight or obese adults with no prior exposure to GLP-1 agonists, administering a 1 mg dose of Wegovy after a one-week pretreatment with either tradipitant 85 mg twice daily or placebo [3][4] - The study successfully met its primary endpoint, with 29.3% of tradipitant-treated patients experiencing vomiting compared to 58.6% on placebo, indicating a 50% relative reduction [4] - The key secondary endpoint was also met, showing a reduction in significant nausea to 22.4% in the tradipitant group versus 48.3% on placebo [5] Market Potential - Vanda Pharmaceuticals emphasized tradipitant's potential to mitigate nausea and vomiting, which are common reasons for early discontinuation of GLP-1 therapies, affecting 30-50% of patients [6] - If validated in larger studies, tradipitant could become a valuable adjunct in the expanding GLP-1 market, which surpassed $50 billion in the first nine months of 2025 [9] Future Plans - Based on the positive phase II results, Vanda plans to initiate a phase III program in the first half of 2026 to advance tradipitant as an adjunct therapy for patients on GLP-1 agonists [11] - The company is also exploring tradipitant for other conditions, including gastroparesis and motion sickness, with a regulatory filing for motion sickness under review by the FDA [12]

Core Insights - Vanda Pharmaceuticals Inc. has released positive topline results from its clinical study evaluating tradipitant for preventing nausea and vomiting induced by Wegovy, a GLP-1 receptor agonist [1][4][6] Study Results - The clinical trial involved 116 healthy overweight or obese adults and successfully met its primary endpoint, showing a 50% relative reduction in vomiting among tradipitant-treated participants (29.3%) compared to those on placebo (58.6%) [2][4] - The study also met a key secondary endpoint, with 22.4% of the tradipitant group experiencing significant nausea and vomiting, compared to 48.3% in the placebo group [5] - Tradipitant exhibited a favorable safety profile, consistent with previous studies, with no new safety signals observed [5] Market Implications - The results suggest that tradipitant could address the high discontinuation rates (30-50%) associated with GLP-1 agonists due to nausea and vomiting, potentially transforming its role in the expanding GLP-1 market, which is projected to exceed $50 billion by 2025 [6][8] - Vanda Pharmaceuticals plans to pursue a Phase 3 program for tradipitant, anticipated to begin in the first half of 2026 [8] Stock Performance - Following the announcement, Vanda Pharmaceuticals' shares increased by 16.24%, reaching $5.11 [9]

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]