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Vanda Pharmaceuticals (NasdaqGM:VNDA) Earnings Call Presentation
2026-01-15 12:00
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 ...
What This Insider Trim at AnaptysBio Means for Investors After a 260% Stock Rally
The Motley Fool· 2026-01-11 23:18
Core Insights - AnaptysBio reported a significant insider sale by Director J. Anthony Ware, who sold 3,900 shares for $193,342.50, representing 28.82% of his direct holdings, during a period of strong share price gains [1][2][10] Company Overview - AnaptysBio is a clinical-stage biotechnology company focused on developing antibody therapies for inflammatory and immune-mediated diseases [8] - The company has a market capitalization of $1.39 billion and reported revenue of $169.47 million for the trailing twelve months (TTM) [4] - The stock price increased by 264.63% over the past year, significantly outperforming the S&P 500's 17% gain [4][11] Transaction Details - The transaction involved a sale of 3,900 shares at a price of $49.58, with a post-transaction value of $481,885.20 based on the market close of $50.04 [2][4] - Post-transaction, Ware retains 9,630 shares and has options to purchase an additional 126,085 shares, along with 6,030 restricted stock units, indicating continued economic alignment with the company [10] Context of the Sale - This sale marks Ware's first open-market transaction at AnaptysBio, contrasting with previous administrative filings, suggesting a strategic decision rather than a shift in outlook [6][10] - The timing of the sale coincided with a high stock price following a substantial one-year return, indicating that the sale was likely a portfolio management decision [6][11] Company Performance - AnaptysBio reported $256.7 million in cash and investments at the end of the third quarter, with collaboration revenue increasing to $76.3 million from $30 million a year earlier [11] - The company's strong balance sheet and revenue visibility support the underlying investment thesis despite insider selling [11]
What Investors Should Know About a $163K AnaptysBio Insider Sale
The Motley Fool· 2026-01-11 16:39
This clinical-stage biotech specializing in antibody therapeutics reported a notable insider sale amid ongoing development and partnerships.Paul F. Lizzul, the chief medical officer of AnaptysBio (ANAB +1.99%), reported the direct sale of 3,650 shares of the company for a total consideration of approximately $163,191.50 on Thursday, as disclosed in a recent SEC Form 4 filing.Transaction summaryMetricValueShares sold (direct)3,650Transaction value$163,191.50Post-transaction shares (direct)42,088Post-transact ...
Anaptys Files Motion to Dismiss Tesaro's Claim of Anticipatory Breach of Contract in Ongoing Litigation Against Tesaro, a GSK subsidiary
Globenewswire· 2026-01-08 23:00
Core Viewpoint - AnaptysBio is engaged in a legal dispute with Tesaro and GSK regarding a Collaboration and Exclusive License Agreement, with a trial scheduled for July 14-17, 2026, to resolve all claims [1]. Group 1: Legal Proceedings - Anaptys filed a partial motion to dismiss Tesaro's anticipatory breach of contract claim in Delaware Chancery Court [1]. - Tesaro initiated a lawsuit against Anaptys on November 20, 2025, claiming Anaptys had repudiated the Collaboration Agreement [2]. - Anaptys responded with its own complaint, asserting that Tesaro materially breached the Collaboration Agreement and that GSK tortiously interfered with it [3]. Group 2: Motion to Dismiss - Anaptys filed a Motion to Dismiss Tesaro's claim on December 30, 2025, arguing that it has not repudiated the Collaboration Agreement and is merely asserting its contract rights [4]. - The motion also invokes Delaware's anti-SLAPP law, which aims to prevent lawsuits that deter good-faith legal rights assertions [4]. - Tesaro and GSK argue that Anaptys' Motion to Dismiss should stay all discovery, which Anaptys opposes as they prepare for the upcoming trial [5]. Group 3: Collaboration Agreement Details - The Collaboration Agreement, established in March 2014, allows Anaptys to receive royalties from Jemperli sales, structured as follows: 8% for net sales below $1 billion, 12% for sales between $1 billion and $1.5 billion, 20% for sales between $1.5 billion and $2.5 billion, and 25% for sales above $2.5 billion [6][7]. - The royalty term extends until at least the expiration of composition of matter coverage, which is set to expire in 2035 in the U.S. and 2036 in the EU [7]. Group 4: Company Overview - AnaptysBio is a clinical-stage biotechnology company focused on innovative immunology therapeutics for autoimmune and inflammatory diseases [8]. - The company's pipeline includes several candidates, such as rosnilimab for rheumatoid arthritis and ANB033 for celiac disease [8]. - Anaptys plans to separate its biopharma operations from its royalty assets by the end of 2026 to better align with investor interests [9].
Anaptys Files Motion to Dismiss Tesaro’s Claim of Anticipatory Breach of Contract in Ongoing Litigation Against Tesaro, a GSK subsidiary
Globenewswire· 2026-01-08 23:00
Core Viewpoint - AnaptysBio is engaged in a legal dispute with Tesaro and GSK regarding a Collaboration and Exclusive License Agreement, with a trial scheduled for July 14-17, 2026 [1][5]. Group 1: Legal Proceedings - Anaptys filed a partial motion to dismiss Tesaro's anticipatory breach of contract claim in Delaware Chancery Court [1]. - Tesaro initiated a lawsuit against Anaptys on November 20, 2025, claiming Anaptys had repudiated the Collaboration Agreement [2]. - Anaptys responded with its own complaint, asserting that Tesaro materially breached the Collaboration Agreement and that GSK tortiously interfered with it [3]. Group 2: Collaboration Agreement Details - The Collaboration Agreement, established in March 2014, allows Anaptys to receive royalties from sales of Jemperli, with rates of 8% for net sales below $1 billion, 12% for sales between $1 billion and $1.5 billion, 20% for sales between $1.5 billion and $2.5 billion, and 25% for sales above $2.5 billion [6][7]. - The royalty term extends at least until the expiration of composition of matter coverage in 2035 in the U.S. and 2036 in the EU [7]. Group 3: Company Overview - AnaptysBio is a clinical-stage biotechnology company focused on innovative immunology therapeutics for autoimmune and inflammatory diseases [8]. - The company's pipeline includes several candidates, such as rosnilimab for rheumatoid arthritis and ANB033 for celiac disease [8]. - Anaptys plans to separate its biopharma operations from its royalty assets by the end of 2026 to better align with investor interests [9].
Anaptys to Present at the 44th Annual J.P. Morgan Healthcare Conference
Globenewswire· 2026-01-06 21:15
SAN DIEGO, Jan. 06, 2026 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today announced that Daniel Faga, president and chief executive officer of Anaptys, will present at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, Jan 13, 2026 at 4:30pm PT / 7:30pm ET. A live webcast of the presentation will be available on the investor section of the Anaptys website at https://ir.anaptysbio.com/presen ...
VNDA Obtains FDA Nod for Motion Sickness Drug, Stock Gains
ZACKS· 2025-12-31 13:40
Key Takeaways VNDA won FDA approval for tradipitant, branded Nereus, to prevent vomiting caused by motion sickness.Vanda Pharmaceuticals said Nereus is the first new motion sickness drug in more than 40 years.VNDA shares surged 18% after hours following the approval, extending gains into pre-market trading.Vanda Pharmaceuticals, Inc. (VNDA) announced that the FDA has approved its candidate tradipitant for the prevention of vomiting induced by motion.The drug has been approved under the brand name Nereus.Tra ...
3 Biotech Stocks With Major 2026 Catalysts
ZACKS· 2025-12-29 15:15
Industry Overview - The biotech sector experienced a significant recovery in 2025, with the Nasdaq Biotechnology Index increasing by 33.8% [2] - Initial concerns regarding potential high tariffs negatively impacted the industry, but investor sentiment rebounded sharply, leading to a notable recovery [2] Drug Approvals and M&A Activity - The rally in the biotech sector was fueled by a consistent stream of new drug approvals, positive pipeline and regulatory updates, and an increase in mergers and acquisitions (M&A) activity [3] - The FDA approved over 44 drugs in 2025, indicating renewed momentum in the industry, which is expected to continue into 2026 due to investor optimism surrounding key drug approvals and innovation [4] Key Biotech Stocks - Three biotech stocks are highlighted for their potential high-impact catalysts in 2026: Denali Therapeutics (DNLI), Nuvalent, Inc. (NUVL), and Vanda Pharmaceuticals (VNDA) [5] - All three companies showed strong performance in the latter half of 2025, a trend likely to persist into 2026 due to favorable regulatory developments and promising pipeline updates [5] Denali Therapeutics - Denali has a robust pipeline targeting neurodegenerative diseases, including DNL310 (tividenofuspalfa), an enzyme replacement therapy for Hunter syndrome designed to cross the blood-brain barrier [7] - The FDA has extended the review timeline for Denali's BLA for tividenofuspalfa to April 5, 2026, following the submission of updated clinical information [11] - Denali's pipeline also includes candidates for Sanfilippo syndrome, Parkinson's disease, and ulcerative colitis [13] Nuvalent, Inc. - Nuvalent focuses on developing targeted cancer therapies, with its lead candidate zidesamtinib aimed at ROS1-positive non-small cell lung cancer (NSCLC) [14][15] - The FDA has accepted Nuvalent's NDA for zidesamtinib, with a target action date of September 18, 2026 [16] - The company also reported positive data for its second lead candidate, neladalkib, in advanced ALK-positive NSCLC [17] Vanda Pharmaceuticals - Vanda is dedicated to developing therapies for unmet medical needs, with its candidate imsidolimab targeting generalized pustular psoriasis (GPP) [18][19] - The company has requested priority review for imsidolimab, which could lead to FDA approval as early as mid-2026 [20] - Vanda has multiple regulatory catalysts ahead, including reviews for Bysanti and tradipitant, with target action dates in early 2026 [22]
Vanda Announces Submission of Biologics License Application to the FDA for Imsidolimab for the Treatment of Generalized Pustular Psoriasis
Prnewswire· 2025-12-15 12:00
Core Viewpoint - Vanda Pharmaceuticals has submitted a Biologics License Application (BLA) to the FDA for imsidolimab, a novel treatment for generalized pustular psoriasis (GPP), addressing a significant unmet medical need in this rare condition [1][3]. Group 1: Drug Development and Clinical Trials - The BLA submission is supported by positive results from the Phase 3 GEMINI-1 and GEMINI-2 studies, where a single intravenous dose of imsidolimab resulted in rapid disease clearance, with 53% of patients achieving clear or almost clear skin at Week 4 compared to 13% on placebo [2][4]. - In the GEMINI-2 study, patients receiving monthly subcutaneous maintenance doses of imsidolimab maintained clear or almost clear skin with no flares, while the placebo group had a 63% flare rate [5]. Group 2: Market Potential and Company Strategy - GPP is characterized by sudden flares and represents a significant unmet medical need, with prevalence estimates ranging from approximately 2 to 124 cases per million worldwide [2]. - Vanda has requested priority review for the BLA, which could lead to a six-month review cycle and potential FDA approval by mid-2026, leveraging its commercial infrastructure to address GPP [3][8]. Group 3: Company Background and Product Information - Vanda Pharmaceuticals focuses on developing innovative therapies for high unmet medical needs, with imsidolimab being a fully humanized IgG4 monoclonal antibody targeting IL-36 receptor signaling [8][10]. - The company holds an exclusive global license for imsidolimab from AnaptysBio, with regulatory and patent exclusivity expected to extend into the late 2030s [8].
Anaptys Announces Participation in December Investor Conferences
Globenewswire· 2025-11-25 21:15
Group 1 - AnaptysBio, Inc. is a clinical-stage biotechnology company focused on innovative immunology therapeutics for autoimmune and inflammatory diseases [2] - The company's pipeline includes rosnilimab, ANB033, and ANB101, with various stages of clinical trials [2] - Anaptys plans to separate its biopharma operations from its royalty assets by year-end 2026 to better align with investor interests [3] Group 2 - Upcoming investor conferences include the Piper Sandler 37th Annual Healthcare Conference and the Evercore 8th Annual Healthcare Conference [1] - Live webcasts of the events will be available on the Anaptys investor website, with replays accessible for at least 30 days [1] - The company is engaging in fireside chats and one-on-one investor meetings on specific dates in December 2025 [4]