Core Viewpoint - Amgen's drug Uplizna has received FDA approval for treating generalized myasthenia gravis (gMG) in adults with specific antibody profiles, marking a significant advancement in the treatment landscape for this rare disease [1][10]. Group 1: Drug Approval and Efficacy - Uplizna is the first CD19-targeted B-cell therapy approved for gMG, providing a twice-yearly dosing option, which is a notable advantage over existing therapies that require more frequent administration [2][10]. - The FDA's approval is based on data from the phase III MINT study, demonstrating strong efficacy in gMG patients [3][10]. - This approval represents the second for Uplizna in 2023 and its third overall in the U.S., following approvals for immunoglobulin G4-related disease and neuromyelitis optica spectrum disorder [4][10]. Group 2: Market Position and Competition - Uplizna enters a competitive market for gMG therapies, competing with argenx's Vyvgart/Vyvgart Hytrulo, J&J's Imaavy, and UCB's Rystiggo [6][10]. - While Uplizna, Vyvgart/Vyvgart Hytrulo, and Rystiggo are approved for adults, Imaavy has a broader age eligibility, being approved for patients aged 12 years and older [8]. Group 3: Financial Performance and Valuation - Amgen's shares have outperformed the industry year to date, indicating strong market performance [9][10]. - The company is currently trading at a price/earnings (P/E) ratio of 14.67, which is below the industry average of 16.59, suggesting a potential undervaluation [12]. - Earnings per share (EPS) estimates for 2025 and 2026 have increased in the past 30 days, reflecting positive market sentiment [13].

Market Overview - International equities showed mixed results in Q3 2025, with the MSCI EAFE Index rising 4.8%, driven by Asian markets and Canada, while Europe Ex U.K. underperformed [3] - The MSCI Emerging Markets Index advanced 10.6%, supported by a 20.7% rally in China, which constitutes 30% of that benchmark [3] - European markets experienced a slowdown in momentum due to inflation remaining above the European Central Bank's target, with a September reading of 2.2% [4] Economic Conditions - Japan's GDP grew modestly in Q2, aided by tourism, while manufacturing activity remained restrained [5] - The People's Bank of China cut key lending rates in July to address weaknesses in the real estate sector and sluggish consumer demand, with Q2 GDP growth at 5.2% year over year [5] Investment Strategy - The MSCI EAFE Value Index outperformed the MSCI EAFE Growth Index by over 500 basis points in Q3, with value stocks leading growth by more than 1,300 basis points year to date [6] - The ClearBridge International Growth Strategy maintained pace with its core MSCI EAFE benchmark, with sector positioning in IT and financials creating headwinds [12] Company Performance - London Stock Exchange faced a decline due to AI concerns impacting its desktop and data business, while Adyen's revenue missed expectations [13] - Banco Santander was acquired for its streamlined operations and cost-cutting measures, expected to improve profitability [14] - HSBC is well-positioned for growth in Asian wealth management, benefiting from inflows of mainland Chinese money [15] - KBC Group's strong capital position allows for capital distributions or acquisitions, with growing assets under management [16] Sector Contributions - Health care sector saw solid contributions, particularly from European biotechs Argenx and UCB, driven by strong sales and positive clinical trial results [20] - The strategy expanded into the Chinese biotechnology sector with the purchase of WuXi AppTec, known for efficient drug development [21] Portfolio Adjustments - The strategy added 10 positions while exiting 13, with significant purchases in financials and health care, including Prysmian, which is poised for growth in the power cables industry [22] - Softbank trades at a discount to its NAV, holding stakes in key technology companies [23] - Celestica is positioned for growth in AI infrastructure, with expected annual revenue growth of over 20% [24] Outlook - The regions of investment are making progress on growth and equity-friendly policies, with forecasts for double-digit EPS growth in the pan-European Stoxx 600 [27] - Emerging markets are outperforming developed markets, with a focus on China’s growth potential in AI and biotechnology [28][32]

Core Insights - Amgen reported positive results from the phase III MINT study for Uplizna, indicating its potential for label expansion in generalized myasthenia gravis (gMG) [1][4] Group 1: Study Results - Uplizna demonstrated durable efficacy in AChR-positive gMG patients over 52 weeks, with a 2.8-point improvement in MG-ADL scores compared to placebo [2] - 72% of AChR+ patients treated with Uplizna showed an improvement of three or more points in MG-ADL scores, versus 45% in the placebo group [2] - In the QMG score, 69% of AChR+ patients on Uplizna improved by three or more points, compared to nearly 42% in the placebo group [3] Group 2: Regulatory and Market Position - Amgen plans to submit a regulatory filing for Uplizna with the FDA by the first half of 2025, currently approved for neuromyelitis optica spectrum disorder [4] - A regulatory filing for Uplizna in immunoglobulin G4-related disease is under review, with a decision expected by April 3, 2025 [4] - Uplizna, part of Amgen's rare disease franchise, was acquired through the $28 billion purchase of Horizon Therapeutics in 2023 [9] Group 3: Competitive Landscape - The 52-week results from the MINT study provide Uplizna an advantage over competitors like argenx's Vyvgart and UCB's Rystiggo, which require weekly dosing, while Uplizna requires dosing every six months [8] - Uplizna has received orphan drug designation from the FDA for the gMG indication [8] Group 4: Stock Performance - Year to date, Amgen's shares have increased by over 20%, outperforming the industry growth of 6% [5]