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argenx Reports Third Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-10-30 06:00
Core Insights - argenx SE reported $1.13 billion in global product net sales for Q3 2025, marking a significant increase of $554 million year-over-year and $178 million quarter-over-quarter, indicating strong market performance and confidence from patients and prescribers [1][5][18] - The company is on track to submit a supplemental Biologics License Application (sBLA) for seronegative generalized myasthenia gravis (gMG) by the end of 2025 and anticipates reporting results from the ADAPT-OCULUS study in the first half of 2026, aiming for the broadest MG label of any biologic [1][5][28] - argenx is advancing its Vision 2030 strategic priorities, which include treating 50,000 patients globally, securing 10 labeled indications, and progressing five pipeline candidates into Phase 3 development by 2030 [3][28] Financial Performance - Total operating income for Q3 2025 was $1.2 billion, compared to $0.6 billion in Q3 2024, while total operating expenses were $805 million, up from $575 million in the same period [15][18] - The profit for Q3 2025 was $344 million, significantly higher than the $91 million reported in Q3 2024, with basic earnings per share increasing to $12.41 from $0.99 [19][18] - Cash, cash equivalents, and current financial assets totaled $4.3 billion as of September 30, 2025, compared to $3.4 billion at the end of 2024, reflecting a strong liquidity position [20][31] Product Development and Pipeline - VYVGART, the company's leading product, is approved in three indications, including gMG and CIDP, with ongoing efforts to expand its label through registrational studies [4][5] - Five registrational study readouts are expected in 2026, with ongoing studies in various autoimmune diseases, including ocular MG and primary immune thrombocytopenia (ITP) [5][12] - The company is also advancing multiple first-in-class product candidates, including empasiprubart and ARGX-119, targeting severe autoimmune diseases [7][8][9] Strategic Initiatives - argenx is expanding its global reach with VYVGART and aims to leverage its innovation playbook to drive growth in new indications, targeting tens of thousands more patients [2][5] - The company has expanded its partnership with FUJIFILM to include a new manufacturing site in North Carolina, enhancing its global supply chain [5] - The Immunology Innovation Program (IIP) continues to be a focus for sustainable pipeline growth, with four new pipeline candidates nominated [9][28]
argenx Presents New Data at AANEM and MGFA Highlighting the Strength and Broad Benefit of VYVGART for Myasthenia Gravis Patients
Globenewswire· 2025-10-29 15:00
Core Insights - Argenx SE presented new data on the efficacy and safety of VYVGART for generalized myasthenia gravis (gMG) at the 2025 AANEM and MGFA meetings, highlighting its potential to improve patient outcomes across various gMG populations [1][2][3] Efficacy and Safety Data - The pivotal Phase 3 ADAPT SERON trial demonstrated that AChR-Ab seronegative gMG patients treated with VYVGART achieved a statistically significant improvement in MG-ADL total score compared to placebo, with a mean change of 3.35 points at week 4 [6] - Approximately 60% of VYVGART-treated gMG patients achieved minimal symptom expression (MSE), with 88% sustaining MSE for at least 4 weeks [5][6] - Real-world data indicated that over 70% of patients treated with VYVGART significantly reduced glucocorticoid use while maintaining clinical benefits [5][15] Treatment Impact - VYVGART is positioned as a targeted, effective, and safe treatment for gMG patients, regardless of autoantibody status, with ongoing studies contributing to redefining treatment standards [4][7] - The ADAPT Jr study showed that VYVGART improved outcomes in adolescents with gMG, addressing a high unmet need in this population [8] Regulatory Plans - Argenx plans to share the ADAPT SERON trial results with the U.S. FDA to seek an expansion of the VYVGART label to include adult AChR-Ab seronegative gMG patients across all subtypes [7] Long-term Outcomes - Long-term treatment with VYVGART was associated with substantial reductions in oral glucocorticoid use, with 72.5% of patients achieving meaningful tapering and an average daily dose reduction of over 50% after 18 months [15][26]
Citi Remains Bullish on Argenx SE (ARGX)
Yahoo Finance· 2025-10-28 16:24
Core Insights - Argenx SE (NASDAQ:ARGX) is recognized as a highly profitable biotech stock, with analysts maintaining a positive outlook and setting high price targets [1][2] Financial Performance - The company reported impressive Q2 revenues for its medication Vyvgart, achieving a 20% quarter-over-quarter growth, which exceeded expectations [2] - Q3 revenue is projected to surpass $1 billion, driven by the drug's expansion into new geographical regions and the anticipated approval of a prefilled syringe [3] Analyst Ratings - Citi analyst Samantha Semenkow maintained a Buy rating on Argenx SE and set a price target of $1,041 [1] - Bank of America Securities analyst Tazeen Ahmad also reiterated a Buy rating, increasing the price target from $887 to $942 [1][2] Market Segments - Argenx SE operates through four segments: the United States, Japan, EMEA, and China, focusing on treatments for severe autoimmune diseases [3]
Baron Health Care Fund Q3 2025 Top Contributors And Detractors
Seeking Alpha· 2025-10-27 17:27
Core Viewpoint - The article discusses the importance of enabling Javascript and cookies in browsers to ensure proper functionality and access to content [1] Group 1 - The article highlights that users may face access issues if they have an ad-blocker enabled [1] - It suggests disabling ad-blockers and refreshing the page to proceed [1]
Baron Health Care Fund Q3 2025 Shareholder Letter
Seeking Alpha· 2025-10-27 17:01
Performance Overview - Baron Health Care Fund increased 5.39% in Q3 2025, outperforming the Russell 3000 Health Care Index's 5.05% but underperforming the Russell 3000 Index's 8.18% [2][3] - Since inception on April 30, 2018, the Fund has achieved an annualized return of 9.30%, compared to 8.68% for the Benchmark and 14.48% for the Index [2][4] Key Contributors - Strong stock selection in biotechnology, particularly from argenx SE and Insmed Incorporated, contributed significantly to the Fund's performance [5] - Argenx's Vyvgart sales exceeded expectations, while Insmed's Brinsupri received U.S. approval, representing a $5 billion-plus opportunity [5][16] - Investments in health care services, particularly RadNet, Inc. and Heartflow, Inc., also added value, with RadNet's shares rising due to strong quarterly results and guidance [6][7][17] Key Detractors - Poor stock selection in health care equipment, particularly from Masimo Corporation and Boston Scientific Corporation, negatively impacted performance [8][9] - Eli Lilly's stock fell due to disappointing Phase 3 trial results for orforglipron, alongside broader regulatory uncertainties affecting the pharmaceutical sector [12][21] - The Fund's underweight position in Johnson & Johnson, which saw a 22.3% increase, also detracted from relative performance [12] Portfolio Structure - The Fund held 46 stocks, with a significant overweight in biotechnology (31.8%) and health care equipment (24.0%), while being underweight in pharmaceuticals (15.2%) [24][28] - The top 10 holdings represented 47.8% of net assets, with Eli Lilly and argenx being the largest positions [26] Recent Activity - The Fund added 16 new positions and exited five, maintaining a focus on attractive valuations in the health care sector [29] - Notable purchases included AbbVie Inc., UnitedHealth Group, and Roivant Sciences, while positions in argenx and Eli Lilly were reduced to manage risk [30][31][37] Market Outlook - The health care sector is expected to offer attractive investment opportunities driven by demographic trends, chronic disease prevalence, and technological advancements [14][40] - Recent agreements, such as Pfizer's MFN pricing deal, are seen as positive for the pharmaceutical sector, with limited financial impact anticipated [38]
argenx to Report Third Quarter 2025 Financial Results and Business Update on October 30, 2025
Globenewswire· 2025-10-23 05:00
Core Insights - argenx will host a conference call and audio webcast on October 30, 2025, at 1:30 PM CET to discuss its Q3 2025 financial results and provide a business update [1]. Company Overview - argenx is a global immunology company focused on improving the lives of individuals suffering from severe autoimmune diseases [3]. - The company collaborates with leading academic researchers through its Immunology Innovation Program (IIP) to translate immunology breakthroughs into a portfolio of novel antibody-based medicines [3]. - argenx has developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker, evaluating its potential in multiple serious autoimmune diseases while advancing several earlier-stage experimental medicines [3].
Argenx(ARGX)深度研究:从亏损到年赚8.3亿美元,FcRn抑制剂如何颠覆自身免疫疾病市场?
贝塔投资智库· 2025-10-17 05:46
Company Overview - Argenx SE is a global biotechnology company founded in 2008, focused on developing innovative immunotherapies for severe autoimmune diseases using its proprietary SIMPLE Antibody™ platform [1] - The core product, VYVGART (efgartigimod alfa), is a novel neonatal Fc receptor (FcRn) blocker approved for treating generalized myasthenia gravis (gMG) in multiple countries, with plans for further indications [1] - Sales of VYVGART grew from $400 million in 2022 to $2.19 billion in 2024, demonstrating strong commercialization capabilities, and the company achieved its first annual profit in 2024 with a net income of $833 million [1] Financial Performance - Argenx's financial performance shows explosive growth, reflecting the successful commercialization of VYVGART [2] - Revenue increased from $401 million in 2022 to $2.252 billion in 2024, representing a compound annual growth rate (CAGR) of 136% [3][18] - The company transitioned from a net loss of $710 million in 2022 to a profit of $833 million in 2024, driven by scale effects, improved operational efficiency, and tax benefits [4] Product Commercialization - VYVGART's net sales in 2024 reached $2.186 billion, with the U.S. accounting for approximately 86.56% of sales [4] - The product is available in various formulations, including intravenous (VYVGART IV) and subcutaneous (VYVGART SC, branded as Hytrulo), enhancing patient convenience [5][7] - VYVGART SC, approved in June 2023, allows for at-home administration, significantly improving patient convenience and expected to contribute over 30% of sales by 2025 [7] Market Expansion and Penetration - Argenx is actively expanding VYVGART into additional indications, with gMG as the core indication approved in over 30 countries [8] - The company is conducting clinical trials for 15 additional autoimmune diseases, with a focus on expanding market penetration [9] - As of 2024, an estimated 15,000 patients globally have received VYVGART treatment, indicating significant growth potential in a market with approximately 60,000-80,000 gMG patients [9] Clinical Efficacy and Patient Acceptance - VYVGART has shown strong clinical efficacy, with 98.1% of patients experiencing significant improvement in MG-ADL scores [13] - Patient satisfaction is high, with over 90% expressing satisfaction with nursing case management services and nearly 80% willing to recommend the treatment [12] Competitive Landscape - Argenx faces competition from major players like AstraZeneca and UCB, but VYVGART maintains a strong market position due to its unique mechanism and clinical advantages [15] - The product's rapid onset of action and good safety profile provide a competitive edge in the autoimmune disease treatment market [16] Investment Highlights - Argenx presents strong investment potential with a current market valuation of approximately $40-45 billion and expected revenue growth rates of 50-70% in the short term [18] - The company has a robust financial position with $3.4 billion in cash and no long-term debt, supporting its growth strategy [18] - The management team has demonstrated strong execution capabilities and a clear strategic vision for future growth [18]
INCY or ARGX: Which Is the Better Value Stock Right Now?
ZACKS· 2025-10-16 16:41
Core Viewpoint - Investors are evaluating Incyte (INCY) and argenex SE (ARGX) for potential undervalued stock opportunities, with INCY currently appearing as the more favorable option based on various valuation metrics and earnings outlook [1][3][7]. Valuation Metrics - Incyte has a forward P/E ratio of 14.34, significantly lower than argenex SE's forward P/E of 51.00, indicating that INCY may be undervalued compared to ARGX [5]. - The PEG ratio for Incyte is 0.57, while argenex SE has a PEG ratio of 0.88, suggesting that INCY offers better value relative to its expected earnings growth [5]. - Incyte's P/B ratio stands at 4.13, compared to argenex SE's P/B of 8.19, further supporting the notion that INCY is more attractively valued [6]. Earnings Outlook - Incyte holds a Zacks Rank of 2 (Buy), indicating a positive earnings outlook, while argenex SE has a Zacks Rank of 3 (Hold), suggesting a less favorable earnings estimate revision trend [3][7]. - The stronger estimate revision activity for Incyte implies that its earnings outlook is improving more significantly than that of argenex SE [7]. Value Grades - Based on the analysis of various valuation metrics, Incyte has been assigned a Value grade of B, while argenex SE has a Value grade of C, indicating that INCY is perceived as a better value investment at this time [6].
Should You Be Confident in Argenx SE’ (ARGX) Long-Term Profit Cycle?
Yahoo Finance· 2025-10-15 12:15
Core Insights - Artisan Partners' "Artisan Mid Cap Fund" reported strong performance in Q3 2025, with the Investor Class fund returning 8.80%, Advisor Class fund also at 8.80%, and Institutional Class fund at 8.83%, significantly outperforming the Russell Midcap Growth Index's return of 2.78% [1] - The fund's outperformance was primarily driven by holdings in the health care sector, particularly highlighting Argenx SE (NASDAQ:ARGX) as a top contributor [1][3] Fund Performance - Global equity markets showed strength in Q3 2025, ending the period with double-digit year-to-date gains [1] - The Artisan Mid Cap Fund's returns for the different classes were as follows: Investor Class (ARTMX) 8.80%, Advisor Class (APDMX) 8.80%, and Institutional Class (APHMX) 8.83% [1] Company Spotlight: Argenx SE - Argenx SE (NASDAQ:ARGX) is a commercial-stage biopharma company with a one-month return of 10.70% and a 52-week gain of 50.38%, closing at $812.95 per share with a market capitalization of $149.06 billion on October 14, 2025 [2] - Argenx's VYVGART®, a first-in-class autoimmune therapy, has shown strong growth, supported by a new subcutaneous formulation for self-administration, and is being studied for multiple autoimmune disorders [3] Hedge Fund Interest - Argenx SE (NASDAQ:ARGX) was held by 53 hedge fund portfolios at the end of Q2 2025, a slight decrease from 54 in the previous quarter, indicating a stable interest among hedge funds [4]
argenx to Highlight Key Data and Breadth of Immunology Innovation at 2025 AANEM Annual Meeting and MGFA Scientific Session
Globenewswire· 2025-10-15 05:00
Core Insights - argenx SE is set to present pivotal data for its therapies VYVGART and empasiprubart at the upcoming AANEM Annual Meeting and MGFA Scientific Session, highlighting its commitment to addressing severe autoimmune diseases [1][2] Group 1: VYVGART Developments - VYVGART is being expanded into new patient populations, with data showcasing its potential to treat a broad set of myasthenia gravis patients, including those who are anti-acetylcholine receptor antibody negative [6][7] - The Phase 3 ADAPT SERON study results indicate clinically meaningful improvements in disease activity across all subtypes of generalized myasthenia gravis [7] - Real-world evidence and long-term data reinforce VYVGART's sustained impact on patient outcomes, with over 40 abstracts presented across various neuromuscular diseases [6][7] Group 2: Empasiprubart Progress - Empasiprubart is being evaluated in multiple studies, including Phase 3 trials EMVIGORATE and EMNERGIZE for chronic inflammatory demyelinating polyneuropathy (CIDP), demonstrating argenx's commitment to innovative therapies [7][31] - The Phase 2 ARDA study highlights the clinical efficacy and safety of empasiprubart in multifocal motor neuropathy (MMN), with a Phase 3 study design (EMPASSION) planned to compare its efficacy against intravenous immunoglobulin [7][31] Group 3: Conference Presentations - The AANEM and MGFA sessions will feature oral and poster presentations detailing the clinical development programs for VYVGART and empasiprubart, emphasizing their potential benefits for patients with autoimmune and neuromuscular diseases [6][9] - Key presentations will include results from the ADAPT Jr study investigating VYVGART in juvenile generalized myasthenia gravis and real-world data on glucocorticoid use reduction following efgartigimod initiation [8][9]