Core Viewpoint - The comparison between Exelixis (EXEL) and argenex SE (ARGX) indicates that EXEL currently presents a better value opportunity for investors based on various financial metrics and rankings [1]. Group 1: Zacks Rank and Earnings Estimates - Exelixis has a Zacks Rank of 2 (Buy), while argenex SE holds a Zacks Rank of 3 (Hold), suggesting that EXEL is likely experiencing a more favorable earnings outlook [3]. - The Zacks Rank system emphasizes companies with positive earnings estimate revisions, which supports the notion that EXEL is in a stronger position compared to ARGX [3]. Group 2: Valuation Metrics - EXEL has a forward P/E ratio of 16.86, significantly lower than ARGX's forward P/E of 44.10, indicating that EXEL may be undervalued relative to its earnings potential [5]. - The PEG ratio for EXEL is 0.80, while ARGX has a PEG ratio of 0.98, further suggesting that EXEL offers better value when considering expected earnings growth [5]. - EXEL's P/B ratio stands at 5.75, compared to ARGX's P/B of 6.24, reinforcing the view that EXEL is more attractively priced based on its book value [6]. Group 3: Overall Value Grades - EXEL has received a Value grade of B, while ARGX has a Value grade of C, indicating that EXEL is perceived as a better investment option by value investors [6].

Core Viewpoint - Pomerantz LLP is investigating claims of potential securities fraud or unlawful business practices involving argenx SE and its officers or directors [1] Group 1: Regulatory Concerns - On June 30, 2025, the FDA issued an alert regarding argenx's Vyvgart Hytrulo product, indicating a potential risk of "severe worsening of chronic inflammatory demyelinating polyradiculoneuropathy" [2] - The FDA is currently evaluating the need for regulatory action based on reports received [2] Group 2: Market Reaction - Following the FDA alert, argenx's American Depositary Share (ADS) price decreased by $8.92, or 1.59%, closing at $551.22 per ADS on June 30, 2025 [2]

Core Viewpoint - Argenx SE's stock is experiencing a decline due to serious safety concerns raised by the FDA regarding its drug Vyvgart Hytrulo, particularly related to chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) [1][2] Group 1: FDA Concerns - The FDA has identified severe risks associated with Vyvgart Hytrulo, specifically the worsening of CIDP, which is characterized by inflammation of nerve roots and peripheral nerves [1] - The FDA is currently evaluating the need for potential regulatory action regarding Vyvgart [2] Group 2: Drug Approval and Usage - The European Commission has recently approved Vyvgart 1000mg for subcutaneous injection as a monotherapy for adult patients with progressive or relapsing active CIDP after prior treatments [2] - In April, the FDA approved a self-injection option for Vyvgart Hytrulo for adult patients with generalized myasthenia gravis (gMG) and CIDP [3] Group 3: Stock Performance and Analyst Ratings - Argenx's stock has an average 1-year price target of $753.23, indicating an expected upside of 43.52% [4][6] - There are no bearish recommendations for Argenx, with 13 analysts providing bullish ratings; the highest price target is $1065.0 from Guggenheim, while the lowest is $680.0 from Baird [5][7] - As of the latest check, Argenx's stock is down 6.56% at $523.37 [7]

Core Insights - argenx SE plans to advance the clinical development of ARGX-119, a first-in-class agonist antibody targeting muscle-specific kinase (MuSK), to a registrational study in patients with congenital myasthenic syndromes (CMS) based on favorable Phase 1b study results [1][4] - The Phase 1b study demonstrated a favorable safety profile and consistent functional improvement across multiple efficacy measures, including the Six-Minute Walk Test (6MWT) and Myasthenia Gravis Activities of Daily Living (MG-ADL) score [4][6] Company Overview - argenx is a global immunology company focused on improving the lives of individuals with severe autoimmune diseases through innovative antibody-based medicines [9] - The company utilizes a collaborative discovery model, the Immunology Innovation Program (IIP), to develop novel therapies, with ARGX-119 being the sixth molecule to show proof-of-concept [3][9] Clinical Study Details - The Phase 1b study was a multicenter, randomized, double-blinded, placebo-controlled trial assessing the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of ARGX-119 in DOK7-CMS patients [5] - The study included a 12-week treatment period and a follow-up period of nearly seven months, with participants randomized in a 4:1 ratio to receive either ARGX-119 or placebo [5] Disease Context - Congenital Myasthenic Syndromes (CMS) are ultra-rare neuromuscular disorders characterized by early onset and muscle weakness, with DOK7 variations accounting for approximately 24% of CMS cases [6] - The prevalence of CMS is estimated at 5 per million, with DOK7-CMS estimated at 1.2 per million, and there are currently no approved treatments available [6]

Core Viewpoint - The European Commission has approved VYVGART® (efgartigimod alfa) for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP), marking a significant advancement in therapy options for this rare autoimmune disease [1][4][5]. Company Overview - argenx SE is a global immunology company focused on developing treatments for severe autoimmune diseases, with VYVGART SC being the first therapy approved for CIDP in over 30 years [5][11]. - The company aims to translate immunology breakthroughs into a portfolio of novel antibody-based medicines and is actively working on multiple severe autoimmune diseases [11]. Product Details - VYVGART SC is administered as a subcutaneous injection and is available in vials or prefilled syringes, allowing for administration by patients, caregivers, or healthcare professionals [1]. - The treatment regimen starts with weekly doses, which can be adjusted based on clinical evaluation [1]. Clinical Trial Insights - The approval is based on the ADHERE clinical trial, the largest study of CIDP patients to date, where 66.5% of patients treated with VYVGART SC showed clinical improvement [4][7]. - The trial demonstrated a 61% reduction in the risk of relapse compared to placebo, with a primary endpoint met (p<0.0001) [4][8]. Patient Impact - CIDP is a debilitating condition affecting mobility and sensory functions, with 85% of patients requiring ongoing treatment and nearly 88% experiencing residual impairment [3][9]. - The introduction of VYVGART SC is seen as a major step forward for the patient community, providing a targeted therapy that addresses a key mechanism of the disease [2][4]. Regulatory Approval - The European Commission's approval applies to all 27 EU Member States, as well as Iceland, Liechtenstein, and Norway, with efforts underway to ensure patient access [5][6].

Core Insights - Exelixis (EXEL) is currently viewed as a more attractive investment compared to argenex SE (ARGX) for value investors due to its stronger earnings outlook and better valuation metrics [3][7]. Valuation Metrics - EXEL has a forward P/E ratio of 17.95, significantly lower than ARGX's forward P/E of 41.38, indicating that EXEL is potentially undervalued [5]. - The PEG ratio for EXEL is 0.85, while ARGX has a PEG ratio of 0.96, suggesting that EXEL offers better value relative to its expected earnings growth [5]. - EXEL's P/B ratio stands at 5.38, compared to ARGX's P/B of 6.39, further supporting the notion that EXEL is more attractively priced [6]. Investment Ratings - EXEL holds a Zacks Rank of 2 (Buy), indicating a positive earnings estimate revision trend, while ARGX has a Zacks Rank of 3 (Hold) [3]. - The Value grade for EXEL is B, whereas ARGX has a Value grade of C, reflecting EXEL's superior valuation metrics [6].

Core Insights - Argenx SE announced positive results from Phase 2 studies of VYVGART® (efgartigimod) for treating Sjogren's disease and idiopathic inflammatory myopathies, presented at EULAR 2025 [1][2][3] - The FDA granted efgartigimod Fast Track designation for primary Sjogren's disease treatment, indicating its potential for expedited development [2] Group 1: Efgartigimod in Myositis - The ALKIVIA Phase 2/3 study showed significant improvement in muscle strength and physical function in myositis patients treated with efgartigimod, with a mean Total Improvement Score (TIS) of 50.45 compared to 35.65 in the placebo group (P=0.0004) [4][5] - 79% of efgartigimod-treated patients achieved moderate improvement (TIS ≥40), while only 47% of placebo patients did [4] - Efgartigimod demonstrated a favorable safety profile, with similar rates of treatment-emergent adverse events between efgartigimod and placebo groups [5][11] Group 2: Efgartigimod in Sjogren's Disease - In the Phase 2 RHO study, 45.5% of efgartigimod-treated patients showed improved outcomes on the CRESS composite primary endpoint at Week 24, compared to 11.1% in the placebo group [9][10] - The median change in clinESSDAI total score was -7.0 for efgartigimod patients versus -4.0 for placebo [9] - Efgartigimod led to a ~60% reduction in IgG levels from Week 4 onwards, indicating its potential for disease biology modulation [10][12] Group 3: Ongoing Studies and Future Directions - The Phase 3 portion of the ALKIVIA study is ongoing to further evaluate efgartigimod's efficacy in myositis [6] - The Phase 3 UNITY trial is assessing efgartigimod's efficacy and safety in moderate to severe Sjogren's disease [11] - Argenx is committed to exploring new therapeutic areas in rheumatology, with ongoing studies in both myositis and Sjogren's disease [8][20]

Company Overview - argenx is a global immunology company focused on improving the lives of individuals suffering from severe autoimmune diseases [3] - The company is known for developing and commercializing the first approved neonatal Fc receptor (FcRn) blocker, with ongoing evaluations of its potential across multiple serious autoimmune diseases [3] Upcoming Event - Karl Gubitz, the Chief Financial Officer of argenx, will participate in a fireside chat at the Goldman Sachs 46th Annual Global Healthcare Conference on June 10, 2025, at 8:40 AM ET in Miami, FL [1] - A live webcast of the presentation will be available on the Investors section of the argenx website, with a replay accessible for approximately 30 days following the event [2]

Core Points - Argenx SE held its Annual General Meeting on May 27, 2025, with 91.1% of the share capital represented [1] - All agenda items received the required majority except for the remuneration policy, which received a 73.0% majority against a required 75% [2] - The company's 2024 remuneration report received a 76.7% majority in favor [4] - The annual report and accounts for the financial year ending December 31, 2024, were approved with a 99.9% majority [4] - Anthony Rosenberg was re-appointed as a non-executive director for a two-year term with a 93.6% majority [4] - The Board of Directors was authorized to issue shares and grant rights to subscribe for shares for up to 10% of the outstanding share capital for 18 months, with a 99.4% majority [4] Company Overview - Argenx is a global immunology company focused on improving the lives of individuals with severe autoimmune diseases [3] - The company collaborates with leading academic researchers through its Immunology Innovation Program to develop novel antibody-based medicines [3] - Argenx has developed the first approved neonatal Fc receptor (FcRn) blocker and is exploring its potential in various serious autoimmune diseases [3]

Core Viewpoint - The comparison between Exelixis (EXEL) and argenex SE (ARGX) indicates that EXEL currently presents a better value opportunity for investors based on various financial metrics and analyst outlooks [1][3]. Valuation Metrics - EXEL has a forward P/E ratio of 16.66, significantly lower than ARGX's forward P/E of 43.23, suggesting that EXEL is more undervalued [5]. - The PEG ratio for EXEL is 0.79, while ARGX has a PEG ratio of 1, indicating that EXEL's expected earnings growth is more favorable relative to its price [5]. - EXEL's P/B ratio stands at 5.54 compared to ARGX's P/B of 6.43, further supporting the notion that EXEL is a more attractive investment based on valuation metrics [6]. Analyst Ratings - EXEL holds a Zacks Rank of 2 (Buy), reflecting a strong earnings estimate revision trend, while ARGX has a Zacks Rank of 3 (Hold), indicating a less favorable outlook [3][6]. - The Value grade for EXEL is B, whereas ARGX has a Value grade of C, reinforcing the conclusion that EXEL is the superior value option at this time [6].