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argenx: TED Phase 3 Failure, Vyvgart Growth, And Why I'm Still A Hold (NASDAQ:ARGX)
Seeking Alpha· 2025-12-17 20:07
My last analysis of argenx SE ( ARGX ) followed an on-the-market safety event for its lead product, VYVGART HYTRULO (subcutaneous efgartigimod). The issue, however, seemed more related to how CIDP patients are transitioned from IVIG to VYVGART HYTRULO, rather than just the drug itself. AsAnalyst’s Disclosure:I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it exp ...
Argenx SE (NASDAQ:ARGX) Faces Setback in Phase 3 Thyroid Eye Disease Studies
Financial Modeling Prep· 2025-12-16 00:00
Core Insights - Argenx SE has discontinued its Phase 3 UplighTED studies for efgartigimod SC in adults with moderate to severe thyroid eye disease due to futility, as advised by an Independent Data Monitoring Committee [1][2] - The company plans to conduct a comprehensive analysis of the data post-study closure to inform future research in thyroid eye disease [2] - Despite this setback, Argenx remains committed to advancing its portfolio of novel antibody-based medicines and exploring therapies for serious autoimmune conditions [3] Financial Overview - Argenx's stock has experienced fluctuations, with a recent price target set at $1,248 by Stifel Nicolaus, indicating a potential increase of approximately 40.26% from the current price of $849.52 [4] - The stock has seen a decrease of about 3.24% or $28.43 recently, with a trading range between $827.52 and $853.96 during the day [4] - Over the past year, the stock reached a high of $934.62 and a low of $510.06, with a market capitalization of approximately $51.96 billion [5]
Argenx Halts Phase 3 Thyroid Eye Disease Trial, Peers Like Viridian Therapeutics To Benefit
Benzinga· 2025-12-15 15:25
Core Insights - Argenx SE has decided to discontinue the Phase 3 UplighTED studies for efgartigimod in adults with moderate to severe thyroid eye disease (TED) based on an Independent Data Monitoring Committee's recommendation due to futility [1][3] Study Design and Outcomes - The Phase 3 studies aimed to evaluate the efficacy, safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of efgartigimod PH20 SC in adult participants with TED, with the primary endpoint being the percentage of participants who were proptosis responders at week 24 [4] - Key secondary endpoints included changes in proptosis measurement, total Graves' Orbitopathy Quality of Life (GO-QoL) score, and the percentage of participants with resolution of diplopia at week 24 [5] Safety Profile - Efgartigimod demonstrated a favorable safety and tolerability profile, with no new safety signals identified during the trials [2] Market Implications - The discontinuation of the studies raises questions about the biological differences between TED and related conditions, as noted by analysts [6] - Amgen's Tepezza is currently the only FDA-approved drug for TED, while Viridian Therapeutics' veligrotug is expected to receive FDA approval in 2026 [7] - Analyst projections for peak TED sales for Vyvgart are estimated at $550 million, assuming a 60% probability of success, indicating a secondary opportunity compared to larger programs [7] - Following the news, Argenx shares fell by 4.86% to $835.31 [8]
Argenx, ServiceNow And Other Big Stocks Moving Lower In Monday's Pre-Market Session - argenx (NASDAQ:ARGX), Celldex Therapeutics (NASDAQ:CLDX)
Benzinga· 2025-12-15 13:06
U.S. stock futures were higher this morning, with the Dow futures gaining around 200 points on Monday.Shares of argenx SE – ADR (NASDAQ:ARGX) fell sharply in pre-market trading after the company discontinued its Phase 3 UplighTED studies of efgartigimod SC in thyroid eye disease following a futility review.argenx shares dipped 6% to $825.00 in pre-market trading.Here are some other stocks moving lower in pre-market trading.TryHard Holdings Ltd (NASDAQ:THH) shares tumbled 15.2% to $13.16 in pre-market tradin ...
Argenx, ServiceNow And Other Big Stocks Moving Lower In Monday's Pre-Market Session
Benzinga· 2025-12-15 13:06
Group 1 - U.S. stock futures are higher, with Dow futures gaining around 200 points [1] - Argenx SE shares fell 6% to $825.00 in pre-market trading after discontinuing Phase 3 studies of efgartigimod SC in thyroid eye disease [1] Group 2 - TryHard Holdings Ltd shares tumbled 15.2% to $13.16 in pre-market trading after a previous jump of 58% [2] - Site Centers Corp declined 13.4% to $6.33 in pre-market trading [2] - Exicure Inc dipped 8.7% to $5.80 in pre-market trading after gaining 5% on Friday [2] - Celldex Therapeutics Inc declined 8.4% to $25.19 in pre-market trading [2] - CapsoVision Inc fell 6.4% to $12.03 in pre-market trading after a decline of around 11% on Friday [2] - Zillow Group Inc fell 5.6% to $70.50 in pre-market trading [2] - BeOne Medicines AG declined 4.9% to $303.50 in pre-market trading [2] - ServiceNow Inc fell 4.7% to $824.50 in pre-market trading after a downgrade to Underweight by KeyBanc [2] - WaterBridge Infrastructure LLC fell 4.4% to $20.05 in pre-market trading [2] - Pharming Group N V declined 4.2% to $17.23 in pre-market trading [2]
美股前瞻 | 三大股指期货齐涨 非农与CPI本周齐袭
Sou Hu Cai Jing· 2025-12-15 12:49
Market Movements - US stock index futures are all up, with Dow futures rising by 0.47%, S&P 500 futures up by 0.50%, and Nasdaq futures also increasing by 0.50% [1] - European indices are also showing positive movements, with Germany's DAX up by 0.44%, UK's FTSE 100 up by 0.94%, France's CAC40 up by 1.13%, and the Euro Stoxx 50 up by 0.74% [1] Commodity Prices - WTI crude oil has decreased by 0.42%, trading at $57.00 per barrel, while Brent crude oil has fallen by 0.41%, priced at $60.87 per barrel [2] Economic News - The market is focused on the potential candidates to succeed Jerome Powell as the next Federal Reserve Chair, with President Trump suggesting Kevin Hassett or Kevin Warsh [3] - Key economic data, including the November employment report and CPI data, are set to be released this week, following a recent 25 basis point rate cut by the Fed [3][4] - The bond market is engaged in intense discussions regarding the Fed's future rate cuts, with expectations of two rate cuts next year despite persistent inflation [4] Company News - iRobot has filed for Chapter 11 bankruptcy protection, indicating that existing common stockholders will not receive any equity in the restructured company [6][7] - STMicroelectronics is expected to deliver over 5 billion Starlink chips in the next two years, reflecting the growing demand in the commercial space sector [7] - Sanofi's multiple sclerosis drug tolebrutinib faces delays in FDA approval and has failed in a late-stage trial, potentially threatening its projected $1.7 billion annual sales peak [8] - Argenx has terminated its trial for a thyroid eye disease drug based on recommendations from an independent data monitoring committee, impacting its treatment goals [8] - Rocket Lab has successfully executed its first dedicated launch mission for JAXA, marking a significant milestone for the company in the commercial space sector [9]
明星药物遭重挫!Argenx(ARGX.US)终止甲状腺眼病药物试验,股价创七个月最大跌幅
智通财经网· 2025-12-15 11:39
智通财经APP获悉,比利时生物技术公司Argenx SE(ARGX.US)表示将终止治疗影响眼睛的自免疫疾病 实验药物的后期试验后,其股价创下七个月来最大跌幅。Argenx表示,基于独立数据监测委员会的建 议,正在中重度甲状腺眼病成人患者中进行评估的药物Efgartigimod(品牌名Vyvgart)将停止试验。该公 司股价在布鲁塞尔股市一度下跌9.7%,为5月8日以来最大跌幅。截至发稿,该股美股盘前跌5.31%。 此次试验终止,冲击了该公司到2030年让5万名患者接受治疗的目标。Argenx预计明年将公布针对多种 自免疫疾病的其他四项后期临床试验项目的结果,其中三项涉及Vyvgart。 其他分析师表示,Argenx的长期前景依然看好。 Van Lanschot Kempen的分析师塞巴斯蒂安·范德斯科特在一份报告中写道:"虽然甲状腺眼病本可以为我 们目前110亿美元的销售峰值预测增加8亿美元,但这仅占我们对Vyvgart估值的一小部分。我们将把情 绪性超跌视为买入欧洲必持生物科技股之一的机会。" 分析师迈克尔·沙阿在报告中指出,甲状腺眼病试验的终止"出人意料,这直接意味着一个规模约10万人 的美国潜在患者市 ...
Stock Market Today: Dow Futures, S&P 500 Advance Ahead Of Key Economic Data: iRobot, Argenx, MindWalk In Focus - iRobot (NASDAQ:IRBT)
Benzinga· 2025-12-15 09:41
Market Overview - U.S. stock futures are up early Monday morning, following a mixed week with a rotation from expensive tech stocks to value stocks, despite a third consecutive interest rate cut [1] - The 10-year Treasury bond yielded 4.17%, while the two-year bond was at 3.51%, with a 73.4% likelihood of the Federal Reserve keeping interest rates unchanged in the upcoming meeting [3] Stocks in Focus - iRobot Corp. is down 81.98% pre-market after filing for bankruptcy due to tariffs impacting margins [5] - MindWalk Holdings is expected to report a loss of $0.01 per share on $4 million in revenue, with the stock up 10.73% pre-market [5] - Katapult Holdings is down 9.12% pre-market following an all-stock merger announcement, with poor momentum scores [5] Economic Data and Events - The Empire State Manufacturing Survey results are anticipated, along with speeches from Federal Reserve officials [2][12] - Upcoming economic data includes the home builder confidence index and various economic indicators throughout the week [12] Commodity and Crypto Markets - Crude oil futures are trading higher by 0.31% at approximately $57.42 per barrel, while gold is up 1.10% at around $4,346.35 per ounce [10] - Bitcoin is trading 1.90% higher at $89,848.10 per coin [10]
Stock Market Today: Dow Futures, S&P 500 Advance Ahead Of Key Economic Data: iRobot, Argenx, MindWalk In Focus
Benzinga· 2025-12-15 09:41
Market Overview - U.S. stock futures are up early Monday morning, following a mixed week with a rotation from expensive tech stocks to value stocks, despite a third consecutive interest rate cut [1] - The 10-year Treasury bond yielded 4.17%, while the two-year bond was at 3.51% [3] - The CME Group's FedWatch tool indicates a 73.4% likelihood of the Federal Reserve keeping interest rates unchanged at its next meeting on January 28, 2026 [3] Stocks in Focus - iRobot Corp. is down 81.98% pre-market after filing for bankruptcy due to tariffs impacting margins [5] - MindWalk Holdings is expected to report a loss of $0.01 per share on $4 million in revenue, with the stock up 10.73% pre-market [5] - Katapult Holdings is down 9.12% pre-market following news of an all-stock merger with Aaron's and CCF [5] - Argenx SE is down 6.72% pre-market after discontinuing its Phase 2 studies for thyroid eye disease [4] Economic Data and Events - The Empire State Manufacturing Survey results are anticipated, along with speeches from Federal Reserve officials [2][12] - Upcoming economic data includes the home builder confidence index from the National Association of Home Builders [12] Commodity and Crypto Markets - Crude oil futures are trading higher by 0.31% at approximately $57.42 per barrel [10] - Gold Spot is up 1.10%, hovering around $4,346.35 per ounce [10] - Bitcoin is trading 1.90% higher at $89,848.10 per coin [10]