This week, the biotech space witnessed significant milestones, including FDA approvals, oncology drug acquisitions, and collaborations. Positive clinical trial results were reported across multiple therapeutic areas, including radiographic and non-radiographic axial spondyloarthritis, microcystic lymphatic malformations, pulmonary arterial hypertension, and obesity. Here's a closer look at the details. FDA Approvals & Rejections Armata Pharma Secures FDA QIDP Designation for AP-SA02 Armata Pharmaceuticals, ...

Argenx SE (NASDAQ:ARGX) on Thursday reported upbeat fourth-quarter results and announced positive topline results from the Phase 3 ADAPT OCULUS study evaluating VYVGART in adults with ocular myasthenia gravis (oMG).Argenx reported fourth-quarter earnings of $8.02 per share, beating the consensus of $6.02. Sales jumped from $761.2 million to $1.32 billion, surpassing the consensus estimate of $1.29 billion.“Argenx delivered another standout year of execution in 2025,” said Tim Van Hauwermeiren, CEO of Argenx ...

In Q&A, Massey referenced prior company estimates that seronegative MG could expand the addressable population by about 11,000 patients and ocular MG by about 7,000 patients, noting the ocular figure represented those believed eligible for VYVGART based on market research rather than the entire ocular MG population.Chief Operating Officer Karen Massey said the company views the ADAPT OCULUS results as a “meaningful opportunity” to broaden VYVGART’s reach in MG alongside progress in seronegative MG. She reit ...

Artisan Partners, an investment management company, released its fourth-quarter 2025 investor letter for “Artisan Mid Cap Fund”.  A copy of the letter can be downloaded here. The Fund seeks to invest in companies that possess franchise characteristics, with strong earnings trajectories, and are trading at a discount to the estimated private market value. US equities ended a record year with robust fourth-quarter gains. The Fund’s Investor Class, ARTMX, delivered -0.44%, the Advisor Class, APDMX, delivered - ...

2026年生命科学行业展望 2026年生命科学行业展望 | 市场情绪因受访者所处区域和细分领域而异 市场情绪因受访者所处区域和细分领域而异 生命科学行业高管认为企业财务前景比较乐观，但需在复杂国际局势中增强韧性 2026年生命科学行业展望 生命科学行业的"无国界属性"或许日益凸显，但行业信心却出现分化。德勤《2026 年生命科学行业展望调研》显示，超过75% 的生物制药与医疗科技行业受访高管对企业 来年的财务前景抱有信心；但仅41% 的受访者对全球经济的健康程度持乐观态度。 未来一年，能够在"把握全球发展趋势"与"增强本地运营韧性"间实现平衡的企业或 将脱颖而出――既需大胆布局人工智能与新兴技术，也需具备灵活应对监管及经济变化 的能力。 为深入了解行业关注重点，德勤美国健康解决方案中心联合德勤全球，于2025 年8-9 月开展了第四次年度生命科学行业展望调研。本次调研覆盖280 位来自美国、欧洲（法 国、德国、瑞士、英国）及亚洲（中国、日本）的生物制药与医疗科技企业高管；同时 结合对多位行业领袖的深度访谈，进一步丰富了调研洞察。（详见《调研方法》部分） 整体而言，多数受访行业领导者认为，2026 年的实质性转 ...

Core Insights - Halozyme Therapeutics (HALO) reported a fourth-quarter 2025 adjusted loss of 24 cents per share, significantly below the Zacks Consensus Estimate of earnings of $2.15, and down from adjusted earnings of $1.26 per share in the same quarter last year [1][6] - The decline in earnings was primarily attributed to a $2.42 per share unfavorable impact from acquired IPR&D expenses related to the Surf Bio acquisition [1] Revenue Performance - Total revenues for the fourth quarter increased by 52% year over year to $451.8 million, surpassing the Zacks Consensus Estimate of $449 million [2] - The growth in revenue was driven by increased product sales and higher royalty payments, with royalty revenues totaling $258 million, up 51% from the previous year [4][6] Product Sales and Royalties - Product sales reached $122.7 million in the fourth quarter, reflecting a 54.5% increase year over year, although it fell short of the model estimate of $123.2 million [7] - Revenues under collaborative agreements were $71.1 million, marking a 47.5% year-over-year increase [7] Financial Metrics - Adjusted EBITDA for the quarter was $21.9 million, a significant decrease from $195.8 million in the same quarter last year [8] - As of December 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $145.4 million, down from $702 million as of September 30, 2025 [8] Full-Year Results and Guidance - For the full year 2025, Halozyme generated revenues of $1.39 billion, a 38% increase year over year, with adjusted earnings of $4.15 per share, down from $4.23 per share in the previous year [9] - The company expects total revenues for 2026 to be between $1.71 billion and $1.81 billion, indicating year-over-year growth of 22% to 30% [10] - Royalty revenues for 2026 are anticipated to be in the range of $1.13 billion to $1.17 billion, reflecting a year-over-year growth of 30% to 35% [10] Future Expectations - Adjusted EBITDA for 2026 is projected to be between $1.125 billion and $1.205 billion, representing a year-over-year increase of 71% to 83% [11] - Adjusted earnings per share for 2026 are expected to be in the range of $7.75 to $8.25, indicating growth of 87% to 99% year over year [11] - Management anticipates a 5% to 10% decrease in royalty revenues for the first quarter of 2026 compared to the fourth quarter of 2025 due to annual contract rate adjustments [12]

Financial Data and Key Metrics Changes - Total revenue grew 38% to $1.4 billion, with royalty revenue increasing 52% to $868 million for the full year 2025 [9][17][19] - Net income for the full year was $316.9 million, compared to $444.1 million in 2024, while adjusted EBITDA was $657.6 million, up from $632.2 million in 2024 [19][20] - GAAP diluted EPS was $2.50, down from $3.43 in 2024, while non-GAAP diluted EPS was $4.15, compared to $4.23 in 2024 [19][20] Business Line Data and Key Metrics Changes - DARZALEX Subcutaneous generated $483 million in royalty revenue, a 29% year-over-year growth, with total sales reaching $14.4 billion [10][19] - Phesgo's royalty revenue increased 51% year-over-year to $105.6 million, with total sales growing 48% to approximately $3 billion [11][19] - VYVGART and VYVGART Hytrulo saw a 444% year-over-year growth in royalty revenues to $157.2 million, with total sales reaching $4.15 billion [12][19] Market Data and Key Metrics Changes - ENHANZE-enabled products now include 10 global blockbuster opportunities, with significant approvals in multiple markets including the U.S., Japan, and China [8][16] - The subcutaneous formulations of Ocrevus, Opdivo, RYBREVANT, and Tecentriq represent a combined market opportunity of approximately $30 billion by 2028 [13][16] Company Strategy and Development Direction - The company aims to expand its ENHANZE portfolio with six new programs entering phase I in 2026, bringing the total development portfolio to 15 products [24][35] - Hypercon technology is expected to meet the demand for lower volume, auto-injector-ready therapies, with projections of approximately $1 billion in royalty revenue within five years of the first launches [26][27] - The company plans to pursue strategic acquisitions to enhance its drug delivery portfolio while maintaining financial discipline [27][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term trajectory of the company, highlighting multiple revenue drivers and the durability of royalty revenue [23][39] - The company anticipates continued strong growth from existing products and new launches, with a focus on expanding into new therapeutic areas [24][35] Other Important Information - The company completed acquisitions of Elektrofi and Surf Bio, enhancing its drug delivery capabilities with long-duration IP [6][27] - The company expects to maintain a strong balance sheet and reduce net debt to below 1x by the end of 2026 [21][22] Q&A Session Summary Question: Regarding the mechanics of DARZALEX collaboration with J&J - Management expects to enter discussions with J&J to extend the agreement closer to its expiration in 2032, emphasizing the importance of the partnership [42][43] Question: On the ADC strategy and regulatory paths - Management indicated that the regulatory pathway for converting IV to subcutaneous delivery would likely follow traditional PK non-inferiority studies [49][50] Question: Update on Hypercon products and clinical testing - Management confirmed that two Hypercon products are on track for phase I clinical testing in 2026, with completion of clinical scale-up batches underway [63][64] Question: Expectations for new partnerships in auto-injectors - Management anticipates progress with high-volume auto-injectors and expects to see interest from both current and new partners [75][76]

Core Insights - Ascendis Pharma A/S is a biopharmaceutical company focused on developing therapies for rare diseases using its proprietary TransCon technology for long-acting prodrugs [1] - The company faces challenges in capital efficiency, as indicated by its negative return on invested capital (ROIC) [1] Financial Metrics - Ascendis Pharma's ROIC is -18.95%, significantly lower than its weighted average cost of capital (WACC) of 5.88%, indicating insufficient returns to cover capital costs [2] - In contrast, argenx SE has a ROIC of 7.68% and a WACC of 4.55%, resulting in a ROIC to WACC ratio of 1.69, demonstrating effective capital utilization [3] - Apellis Pharmaceuticals, Inc. also shows efficient capital use with a ROIC of 8.81% and a WACC of 5.31%, leading to a ROIC to WACC ratio of 1.66 [4] - Blueprint Medicines Corporation shares a similar challenge with Ascendis, having a negative ROIC of -13.09% against a WACC of 8.26%, highlighting inefficiencies in capital utilization [5]

Dianthus Therapeutics Conference Call Summary Company Overview - **Company**: Dianthus Therapeutics (NasdaqCM:DNTH) - **Date**: February 12, 2026 - **Key Executives**: Marino Garcia (CEO), Ryan Savitz (CFO) Key Industry and Company Insights 1. Transformational Year - 2025 was a pivotal year for Dianthus, marked by the first patient data in myasthenia gravis (MG), which exceeded expectations [2][60] 2. Product Pipeline - **DNTH212**: In-licensed from Leads Biolabs, a bifunctional fusion protein targeting BDCA2 to reduce type I interferon and BAFF/APRIL, showing potential as a best-in-class product [2][3] - **Clasiprubart**: An active C1s inhibitor with promising phase 2 data for MG, with two major catalysts expected in 2026 [3][4] 3. Upcoming Catalysts - **CIDP Phase 3 Study**: Interim responder analysis for the first 40 patients is anticipated in Q2 2026, accelerated from H2 2026 due to strong recruitment [4][16] - **MMN Phase 2 Results**: Expected in the second half of 2026 [4] 4. Competitive Landscape - **Riliprubart**: A competitor from Sanofi, currently in phase 3 studies for CIDP. Dianthus aims to demonstrate at least equal efficacy with a more convenient dosing regimen [10][12] - **Empaciperbart**: Another competitor in MMN, with Dianthus expecting similar efficacy but with advantages in administration and safety [31][39] 5. Efficacy Expectations - For CIDP, Dianthus aims for a responder rate of 40%-50% in the interim analysis, comparable to riliprubart's phase 2 data [12][17] - The company is focusing on a dosing regimen that is more efficient, potentially reducing the number of injections required [12][15] 6. Market Potential - The U.S. market for MG is estimated at $5 billion, with potential growth to $20-$25 billion as biologics penetrate further [60] - Dianthus anticipates capturing 5%-10% of the MG market, translating to $2-$4 billion in sales [60][62] 7. Financial Health - Dianthus ended the year with $514 million in cash, sufficient to fund operations through 2028 and support upcoming milestones [64] 8. Safety and Regulatory Considerations - Concerns about drug-induced lupus (DIL) were addressed, emphasizing the reliability of data from clinical trials versus anecdotal reports [54][56] - The company is confident in the safety profile of its products, with no reported cases of DIL in clinical programs [56] 9. Commercial Strategy - Dianthus plans to leverage the convenience of its auto-injector and the absence of a box warning to differentiate its products in the market [41][44] 10. Recruitment and Trial Design - The company is focusing on efficient recruitment strategies and trial designs that allow for quicker results and better patient outcomes [16][20] Conclusion Dianthus Therapeutics is positioned for significant growth with a strong pipeline and strategic focus on efficacy, safety, and market penetration. The upcoming data releases and competitive advantages in product administration are critical to its success in the evolving biotech landscape.

Core Viewpoint - Harmony Biosciences Holdings, Inc. (HRMY) is currently viewed as a more attractive investment compared to argenex SE (ARGX) due to its stronger earnings outlook and better valuation metrics [1][3][7] Valuation Metrics - HRMY has a forward P/E ratio of 9.48, significantly lower than ARGX's forward P/E of 29.52, indicating that HRMY may be undervalued [5] - The PEG ratio for HRMY is 0.35, while ARGX has a PEG ratio of 0.72, suggesting that HRMY offers better value relative to its expected earnings growth [5] - HRMY's P/B ratio stands at 2.61, compared to ARGX's P/B of 8.36, further highlighting HRMY's superior valuation [6] Investment Ratings - HRMY holds a Zacks Rank of 1 (Strong Buy), while ARGX has a Zacks Rank of 3 (Hold), indicating a more favorable investment outlook for HRMY [3][7] - Based on the valuation metrics and earnings outlook, HRMY is considered the superior value option at this time [7]