Company Overview - Vanda Pharmaceuticals is a leading global biopharmaceutical company focused on innovating to enhance people's happiness [2] - The company employs an innovation-led strategy with a successful track record in developing and commercializing therapies over decades [2] Product Portfolio - Vanda has a robust commercial portfolio anchored by four FDA-approved brands: Fanapt (atypical antipsychotic), HETLIOZ (for two orphan sleep disorders), PONVORY (for multiple sclerosis), and the recently approved NEREUS (for motion-induced vomiting) [3] - The company maintains a strong debt-free balance sheet, providing substantial capital for R&D and commercial activities [3] Pipeline and Growth Potential - Vanda has a late-stage growth pipeline with numerous high-potential programs targeting significant unmet needs in billion-dollar markets [4] - The company is positioned for imminent regulatory catalysts, including the recently approved NEREUS [4]

Vanda Pharmaceuticals FY Conference Summary Company Overview - Vanda Pharmaceuticals is a global biopharmaceutical company focused on innovative therapies with a strong commercial portfolio anchored by four FDA-approved brands: Fanapt, Hetlioz, Ponvory, and Nereus [2][3] Core Products and Pipeline - **Fanapt**: An atypical antipsychotic approved for bipolar I disorder and schizophrenia. A long-acting injectable formulation is in phase three for schizophrenia, and a program for hypertension has been initiated [4][5] - **Hetlioz**: Approved for non-24-hour sleep-wake disorder and other sleep disturbances. It is at the regulatory stage for insomnia and jet lag disorder [6][7] - **Ponvory**: Approved for relapsing forms of multiple sclerosis, with ongoing phase three programs for psoriasis and ulcerative colitis [6][7] - **Nereus**: Recently approved for motion sickness, with potential applications in GLP-1 induced nausea and vomiting, and gastroparesis [6][7][10] Financial Performance - For Q3 2025, Vanda reported revenue of $56.3 million, with contributions from Fanapt ($31 million), Hetlioz ($18 million), and Ponvory ($7 million). The company expects total revenue for 2025 to be between $210 million and $230 million [21][22] Strategic Focus - The company aims to grow and diversify revenue by expanding existing products and introducing new ones, targeting six commercial products by the end of 2026 [3][4] - Upcoming regulatory catalysts include Bysanti's PDUFA date on February 21, 2026, and the initiation of phase three programs for GLP-1 induced vomiting [7][10] Market Opportunities - **Nereus**: The motion sickness market has approximately 30% of adults in the U.S. experiencing symptoms, translating to a potential patient population of around 12 million. The GLP-1 market, valued at over $50 billion, presents a significant opportunity for Nereus as an adjunct treatment [11][12][35] - **Bysanti**: Expected to extend the psychiatry portfolio, especially with a potential indication for major depressive disorder (MDD), which could open treatment options for an additional 20 million patients [15][31] Commercialization Strategy - Vanda has a robust sales force of around 300 reps, primarily targeting psychiatrists, but plans to expand efforts to include primary care physicians for Bysanti [26][28] - The company anticipates a transition strategy from Fanapt to Bysanti, leveraging existing resources to maintain revenue streams post-Fanapt's expected loss of exclusivity around 2027 [28][29] R&D Milestones - Nereus's approval for motion sickness was a significant milestone, with a commercial launch expected in the second half of 2026. The company is also pursuing additional indications for its products [7][10] - Imsidolimab, targeting generalized pustular psoriasis, is under priority review with a potential launch in summer 2026 [17][37] Conclusion - Vanda Pharmaceuticals is positioned for significant growth with a strong pipeline and strategic focus on expanding its product offerings. The upcoming regulatory milestones and market opportunities in motion sickness and the GLP-1 space are key drivers for future revenue growth [39]

Core Viewpoint - Vanda Pharmaceuticals Inc. is under investigation for potential violations of federal securities laws following a significant stock price drop due to FDA's decision on its drug application for HETLIOZ® [1][2]. Group 1: Company News - Vanda Pharmaceuticals announced on January 8, 2026, that the FDA's CDER concluded that the supplemental New Drug Application (sNDA) for HETLIOZ® for treating jet lag disorder cannot be approved in its current form [2]. - The FDA acknowledged positive efficacy from Vanda's clinical trials but determined that the evidence was insufficient for effectiveness in treating jet lag disorder, citing that the trial protocols did not adequately simulate actual jet travel conditions [2]. - Following the FDA's announcement, Vanda's stock price fell over 14% on January 8, 2026 [2]. Group 2: Legal and Investigation - Levi & Korsinsky has commenced an investigation into Vanda Pharmaceuticals regarding potential violations of federal securities laws, inviting investors who suffered losses to explore recovery options [1][3].

2026 CORPORATE PRESENTATION January 2026 PHARMACEUTICALS INC. Various statements in this presentation, including, but not limited to, the guidance provided under "2025 Financial Guidance" and statements regarding Vanda's commercial products, plans, priorities and opportunities, as well as statements about Vanda's strategic focus and its products in development and the related clinical development and regulatory timelines and commercial and therapeutic potential for such products, are "forward-looking statem ...

Core Viewpoint - Vanda Pharmaceuticals Inc. is under investigation for potential securities fraud and unlawful business practices following the FDA's rejection of its supplemental New Drug Application for HETLIOZ® [1][3]. Group 1: FDA Decision - On January 8, 2026, Vanda announced that the FDA concluded the supplemental New Drug Application for HETLIOZ® for jet lag disorder cannot be approved in its current form [3]. - The FDA acknowledged positive efficacy from Vanda's clinical trials but determined that the data did not provide substantial evidence of effectiveness for jet lag disorder due to the inadequacy of the controlled phase advance protocols [3]. - Following the FDA's announcement, Vanda's stock price fell by $1.20 per share, or 14.05%, closing at $7.34 per share on January 8, 2026 [3]. Group 2: Legal Investigation - Pomerantz LLP is investigating claims on behalf of Vanda's investors regarding potential securities fraud or other unlawful business practices by the company and its officers and/or directors [1]. - Investors are encouraged to contact Pomerantz LLP for more information regarding the class action [2][6]. Group 3: Pomerantz LLP Background - Pomerantz LLP is recognized as a leading firm in corporate, securities, and antitrust class litigation, with a history of fighting for victims of securities fraud and corporate misconduct [4]. - The firm has a legacy of recovering multimillion-dollar damages awards for class members over its 85-year history [4].

Core Viewpoint - Vanda Pharmaceuticals (VNDA) has experienced a bearish trend recently, losing 5.8% over the past week, but the formation of a hammer chart pattern suggests a potential trend reversal as buying interest may be increasing [1][2]. Technical Analysis - The hammer chart pattern indicates a possible bottoming out, with selling pressure likely subsiding, which could lead to a bullish trend for the stock [2][5]. - A hammer pattern forms when there is a small difference between opening and closing prices, with a long lower wick, suggesting that bears may be losing control [4][5]. - This pattern can occur across various timeframes and is utilized by both short-term and long-term investors [5]. Fundamental Analysis - There has been a positive trend in earnings estimate revisions for VNDA, with a 2.7% increase in the consensus EPS estimate over the last 30 days, indicating that analysts expect better earnings than previously predicted [7][8]. - VNDA holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [9][10]. - The Zacks Rank serves as a timing indicator, suggesting that VNDA's prospects are improving, further supporting the case for a potential turnaround [10].

Core Viewpoint - Vanda and Exante Data Inc have completed a definitive merger agreement, enhancing Vanda's capabilities in high-frequency positioning data and macro insights [1] Company Overview - Vanda is recognized as a global leader in high-frequency positioning data and tactical macro insights [1] - Exante Data Inc is an innovative provider of data analytics and global macro strategy [1] Merger Details - The merger involves Vanda acquiring all outstanding capital stock of Exante Data Inc [1] - Following the merger, Jens Nordvig will take on a leadership role within Vanda [1]

Core Insights - U.S. stock futures are lower, with Dow futures dropping over 100 points on Thursday [1] - Immuneering Corp's shares fell 20.7% to $6.61 in pre-market trading following the announcement of updated survival and safety data from its Phase 2a trial for pancreatic cancer [1] Company Movements - Elme Communities shares decreased 82.8% to $2.98 in pre-market trading [3] - Erasca Inc shares fell 14% to $4.45 after a previous rise of 42% on Wednesday [3] - Phathom Pharmaceuticals Inc shares dropped 13.7% to $15.60 after announcing a $130 million public offering [3] - United Microelectronics Corp shares declined 6.3% to $8.37 after a 10% increase on Wednesday due to reported sales growth [3] - Canadian Solar Inc shares decreased 6.1% to $20.68 following a proposed $200 million public offering [3] - Trevi Therapeutics Inc shares fell 6.1% to $11.00 in pre-market trading [3] - Revolution Medicines Inc shares dipped 6% to $96.57 after reports that AbbVie is not in discussions with the company [3] - Sibanye Stillwater Ltd shares decreased 5.7% to $15.01 in pre-market trading [3] - Vanda Pharmaceuticals Inc shares fell 5% to $8.11 despite FDA approval of its product to prevent motion-induced vomiting [3] - Logitech International SA shares declined 4.8% to $94.91 ahead of its third quarter fiscal year 2026 financial results release [3]

FDA Approvals & Rejections - ARS Pharma's neffy, a needle-free epinephrine nasal spray for emergency treatment of Type I allergic reactions, received approval in China, with commercial availability expected in spring 2026. The product generated $31.3 million in U.S. revenue in Q3 2025 [3][4]. - Vanda Pharmaceuticals' NEREUS, an oral NK-1 receptor antagonist for preventing motion-induced vomiting, received FDA approval, marking the first new treatment for motion sickness in over 40 years. The drug demonstrated a meaningful reduction in vomiting in clinical trials [5][6]. Clinical Trials - Breakthroughs & Setbacks - InflaRx's analyses from a halted Phase 3 trial of Vilobelimab in pyoderma gangrenosum indicated potential efficacy signals with longer treatment duration, prompting plans to discuss alternative endpoints with the FDA [15][17]. - SELLAS reported that survival in its Phase 3 REGAL trial for Galinpepimut-S (GPS) in acute myeloid leukaemia is extending longer than anticipated, potentially increasing the likelihood of a positive outcome [18][19]. - Ultragenyx announced that its Phase 3 studies for Setrusumab in Osteogenesis Imperfecta failed to meet primary endpoints, leading to a decline in investor confidence [20][21]. - Genmab decided to discontinue clinical development of Acasunlimab to focus on higher-priority programs, with no impact expected on its full-year 2025 financial guidance [22][23]. Corporate Actions - FONAR Corporation agreed to be taken private by a CEO-led acquisition group for $19.00 per share, valuing the transaction at a significant premium. The deal is expected to close in Q3 2026, subject to shareholder approval [12][13][14].

Market Sentiment - The CNN Money Fear and Greed index showed a decline in overall market sentiment, remaining in the "Neutral" zone with a current reading of 45.8, down from 48.4 [1][4] - U.S. stocks settled lower, with the Dow Jones index falling more than 300 points, closing at 48,063.29, while the S&P 500 and Nasdaq Composite also recorded declines [1][3] Stock Performance - The S&P 500 increased by 16.39% for the year, marking its third consecutive double-digit annual surge, while the Nasdaq Composite gained 20.36% and the Dow added 12.97% in 2025 [2] - Vanda Pharmaceuticals Inc. saw its shares jump over 25% after receiving FDA approval for NEREUS, aimed at preventing motion-induced vomiting [2] - FuelCell Energy Inc. experienced an 8% decline in its shares following the filing for an amended common stock offering [2] Economic Data - U.S. initial jobless claims decreased by 16,000 to 199,000 for the week ending December 27, which was better than market estimates of 220,000 [3] - All sectors on the S&P 500 closed negatively, with real estate, industrials, and materials stocks experiencing the largest losses [3]