AnaptysBio, Inc.
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Vanda Pharmaceuticals Announces FDA Acceptance of Biologics License Application Filing for Imsidolimab for the Treatment of Generalized Pustular Psoriasis
Prnewswire· 2026-02-25 12:18
are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, the FDA's ability to complete its review of, and reach a decision with respect to, the imsidolimab BLA by December 12, 2026; Vanda's assumptions regarding how imsidolimab achieves its therapeutic effect; Vanda's ability to obtain FDA approval ...
AnaptysBio Teases Q2 Split Into RoyaltyCo and Biopharma Spin, Flags Jemperli and Pipeline Catalysts
Yahoo Finance· 2026-02-11 21:05
Core Viewpoint - AnaptysBio plans to separate its business into two publicly traded entities, focusing on biopharma operations and a royalty portfolio, with a target separation date in Q2 2026, although this may be subject to slight delays [4][7]. Biopharma Operations - The new biopharma entity will include three clinical-stage programs: CD122 (ANB033), ANB101, and rosnilimab, and will be capitalized to reach key readouts in the CD122 program [2][5][12]. - AnaptysBio entered 2026 with approximately $310 million in cash, which could fund the biopharma operations into 2028 if allocated appropriately [5][11]. - CD122 is currently in a phase 1b trial for celiac disease, with data expected in Q4 2026, and plans to initiate a phase 1b trial for eosinophilic esophagitis imminently, with results anticipated in 2027 [13][14]. Royalty Portfolio - The royalty-focused entity will be anchored by royalties on GSK's Jemperli, which is projected to have a revenue run rate of approximately $1.5 billion, potentially reaching $1.8 billion this year if growth trends continue [6][7]. - The royalty rate for Jemperli is structured at 8% up to $1 billion in revenues, escalating to 25% at $2.5 billion [9]. - The royalty entity will also include potential economics from Vanda's imsidolimab, which is seeking accelerated approval for generalized pustular psoriasis [10]. Market Dynamics - Faga noted that GSK's Jemperli has gained market share in frontline endometrial cancer due to positive overall survival data, with European approvals lagging behind the U.S. [8]. - GSK has historically guided for peak sales of Jemperli to exceed £2 billion (approximately $2.7 billion), with potential for additional indications and combinations to contribute to revenue [8]. Strategic Considerations - The separation is framed as a dividend of the biopharma operations to existing shareholders, allowing them to retain proportional ownership in both entities post-separation [3][4]. - AnaptysBio is also addressing ongoing litigation related to Jemperli, which is described as a specific contractual matter that does not impact the separation process [10].
Biotech Leader Eyes Spinoff Amid Massive Sales Surge
Investors· 2026-02-03 18:55
Core Viewpoint - AnaptysBio (ANAB) is experiencing a significant sales surge and has cleared a trendline entry, making it a notable stock for investors to watch [1] Group 1: Company Performance - AnaptysBio stock has shown a turnaround in the third quarter, positioning it as a selection for IBD 50 Stocks To Watch [1] - The stock is currently forming a cup base with a buy point set at 52.47 [1] Group 2: Legal Developments - AnaptysBio is involved in a legal battle with pharmaceutical giant GSK, with both companies filing competing lawsuits over licensing issues [1] Group 3: Stock Ratings and Technical Analysis - AnaptysBio has achieved a Relative Strength (RS) Rating upgrade, indicating improved price strength [1] - The stock has met the benchmark of an 80-plus RS Rating, showcasing its rising relative price strength [1] - AnaptysBio has been recognized for showing improving market leadership with an RS Rating of 83 [1]
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].
After-Hours Gainers: ALXO, GMED, ACRV, And Biotech Peers Rally On Trial Data And Earnings Updates
RTTNews· 2026-01-08 03:14
Group 1: Biotechnology and Healthcare Companies Performance - Several biotechnology and healthcare companies experienced notable gains in after-hours trading due to clinical updates, financial results, and upcoming industry presentations [1] Group 2: ALX Oncology Holdings Inc. - ALX Oncology Holdings Inc. (ALXO) surged 10.17% to $1.30 after announcing positive data from a Phase 2 trial of its lead candidate, evorpacept, in combination with rituximab and lenalidomide for patients with indolent B-cell non-Hodgkin lymphoma [2] - The findings are scheduled to be presented on December 7, 2025, at the American Society of Hematology (ASH) Annual Meeting in Orlando, Florida [2] Group 3: Globus Medical, Inc. - Globus Medical, Inc. (GMED) climbed 9.34% to $99.00 following preliminary unaudited sales results, reporting fourth-quarter 2025 sales of approximately $823.2 million, a 25.2% increase year-over-year [3] - Full-year 2025 sales are expected to reach $2.936 billion, representing a 16.5% increase from the prior year [3] - The company set its 2026 revenue guidance between $3.18 billion and $3.22 billion, with projected non-GAAP earnings per share in the range of $4.30 to $4.40 [3] Group 4: Acrivon Therapeutics, Inc. - Acrivon Therapeutics, Inc. (ACRV) rose 6.44% to $3.14 after announcing plans to release clinical data updates for ACR-368 and ACR-2316 on January 8, 2026 [4] Group 5: Other Companies - AnaptysBio, Inc. (ANAB) advanced 1.75% to $46.00 after confirming that CEO Daniel Faga will present at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026 [5] - Omeros Corp. (OMER) added 4.47% to $14.72 without any new corporate updates [6] - EUDA Health Holdings Limited (EUDA) increased 3.73% to $2.50 after amending its warrant agreement with Streeterville Capital, LLC [6] - TherapeuticsMD, Inc. (TXMD) rose 5.34% to $2.15 in after-hours trading, with no new announcements reported [6] - Pyxis Oncology, Inc. (PYXS) gained 4.93% to $1.49 without any fresh news [7]
This Biotech Stock Has More Than Tripled in 2025, but Red Flags Are Waving
Yahoo Finance· 2025-12-19 17:05
Core Viewpoint - AnaptysBio (ANAB) is a biotechnology company focused on therapeutic antibodies for inflammation and immuno-oncology, currently valued at $1.32 billion [1]. Group 1: Stock Performance - AnaptysBio has surged 227% over the past year, reaching a 5-year high of $49.52 on December 19 [6][4]. - The stock gained 32.5% since the Trend Seeker issued a "Buy" signal on November 18 [2]. - The stock has a Weighted Alpha of +194.83 and a Relative Strength Index (RSI) of 75.79, indicating strong technical momentum [7]. Group 2: Market Sentiment - AnaptysBio has a 100% "Buy" opinion from Barchart, reflecting strong analyst and investor sentiment [6][7]. - Despite the positive sentiment, Wall Street anticipates a decline in earnings and revenue next year [6]. - More than 30% of the float is sold short, suggesting caution among investors [6]. Group 3: Financial Projections - Revenue is expected to grow by 124.23% this year but is projected to decrease by 37.71% next year [7]. - Earnings are estimated to increase by 71.91% this year but are expected to decline by 181.57% next year [7].
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].
J.P. Morgan Maintains a Sell Rating on GSK plc (GSK)
Yahoo Finance· 2025-12-10 16:28
Group 1: Company Overview - GSK plc, formerly known as GlaxoSmithKline, is a global biopharma company based in the United Kingdom, developing and distributing a range of vaccines, medications, and consumer health items [6] - The company has over 20 vaccines in its portfolio and develops cancer treatments for multiple myeloma, ovarian cancer, and endometrial cancer, among others [6] Group 2: Recent Developments - On November 20, GSK's subsidiary, TESARO, Inc., initiated litigation against AnaptysBio, Inc. in the Delaware Chancery Court, claiming a material breach of the existing license agreement regarding Jemperli [2][4] - TESARO asserts its right to terminate the current license agreement due to the alleged breach, which would allow for a 50% reduction in royalties and milestone payments owed to AnaptysBio and secure a perpetual and irrevocable license to dostarlimab [3] Group 3: Product Performance - Jemperli is approved in over 35 countries for specific endometrial cancers, which is the most common gynecologic cancer in the United States [5] - GSK and TESARO have reported significant growth for Jemperli, supported by label expansions in endometrial cancer in both the EU and the US, with ongoing clinical programs evaluating its potential use in other cancers such as colon, rectal, and head and neck [5]
美股减肥药概念股涨跌各异
Ge Long Hui A P P· 2025-11-24 15:00
Group 1 - ANAB stock increased by 4.7% in early trading [1] - Hims & Hers saw a rise of 4.3% [1] - Biogen (BIIB) shares rose by 2.7% [1] Group 2 - Eli Lilly experienced a slight decline [1] - Abbott's stock fell by over 0.6% [1] - Novo Nordisk ADR dropped by over 9% [1]
道指开盘涨0.4%,标普500涨0.4%,纳指涨0.5%
Xin Lang Cai Jing· 2025-11-21 14:36
Group 1 - Google A shares increased by 2.3% following the release of its new AI image generation model, Nano Banana Pro [1] - Elastic's shares fell by 12.6% as its Q2 financial report indicated a slowdown in cloud business growth [1] - AnaptysBio's shares dropped by 11.1% due to a lawsuit filed against it by Tesaro, a subsidiary of GlaxoSmithKline [1] Group 2 - Bilibili's shares rose by 1.2% as institutional investors continued to express positive outlooks following its earnings report [1]