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Yahoo
20-06-2025
- Health
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argenx Announces European Commission Approval of VYVGART Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy
VYVGART® SC, first-and-only IgG Fc-antibody fragment which specifically targets the neonatal Fc receptor (FcRn), now approved for use in Europe for CIDP Approval based on ADHERE clinical trial, the largest study of CIDP patients to date First novel mechanism of action for CIDP treatment in more than 30 years June 20, 2025, 7:00 PM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the European Commission (EC) approved VYVGART® (efgartigimod alfa) 1000mg for subcutaneous (SC) injection as a monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins. VYVGART for SC injection is available as a vial or prefilled syringe and can be administered by a patient, caregiver, or healthcare professional. Treatment is initiated with a weekly dose regimen and may be adjusted to every other week based on clinical evaluation. "The EC's decision has been met with hope and enthusiasm by the European Patient Organisation for Dysimmune and Inflammatory Neuropathies (EPODIN). We see the introduction of a new targeted therapy for CIDP as a major step forward for the patient community," said Jean-Philippe Plançon, President of EPODIN. CIDP is a rare, debilitating, often progressive, immune-mediated neuromuscular disorder of the peripheral nervous system. Patients experience a range of disabling mobility and sensory issues, including trouble standing from a seated position, pain and fatigue, and frequent tripping or falling. People living with CIDP can also become wheelchair bound and unable to work as the disease progresses. Currently, 85% of patients require ongoing treatment and nearly 88% of treated patients experience residual impairment and disability. 'CIDP can severely affect quality of life by causing weakness, loss of balance and mobility, numbness and pain in a patient's arms and legs. For far too long, physicians have had limited options for helping to improve patient outcomes,' said Dr. Luis Querol, M.D., Ph.D., ADHERE Investigator, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. 'The approval of VYVGART SC for the treatment of CIDP marks a turning point in clinical practice, as physicians now have access to a new, effective treatment option that, for the first time, precisely targets a key mechanism of disease and provides meaningful functional improvements to patients.' The EC approval follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) and is based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date. In the study, 66.5% (214/322) of patients treated with VYVGART SC demonstrated evidence of clinical improvement, including in mobility, function and strength. Clinical benefit was seen across all patient subtypes, regardless of prior treatment. ADHERE met its primary endpoint (p<0.0001) demonstrating a 61% reduction (HR: 0.39 95% CI: 0.25; 0.61) in the risk of relapse versus placebo. 99% of trial participants elected to participate in the ADHERE open-label extension. The safety results were consistent with the known safety profile of VYVGART SC in previous clinical studies. 'VYVGART SC is the first therapy with a novel mechanism of action to be approved for this community in more than 30 years,' said Luc Truyen, M.D., Ph.D., Chief Medical Officer of argenx. 'With VYVGART SC, CIDP patients and physicians across Europe will soon have access to an effective novel therapy with a favorable safety profile that has a precise mechanism of action and a convenient self-injection option. This approval further affirms the potential of efgartigimod in IgG-mediated autoimmune diseases.' The EC approval will apply to all 27 European Union Member States, and also to Iceland, Liechtenstein, and Norway. argenx is working closely with local regulatory authorities across the region to ensure that patients who may benefit from VYVGART SC are able to access the novel treatment as soon as possible. This regulatory approval is the second for VYVGART SC in Europe, which first received approval as an add-on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. About ADHERE The ADHERE trial was a multi-center, randomised, double-blind, placebo-controlled trial evaluating efgartigimod alfa SC for the treatment of CIDP. ADHERE enrolled 322 adult patients with CIDP, 130 of whom were based in Europe. The trial consisted of an open-label Stage A followed by a randomized, placebo-controlled Stage B. In order to be eligible for the trial, the diagnosis of CIDP was confirmed by an independent panel of experts. Patients entered a run-in stage, where any ongoing CIDP treatment was stopped and, in order to be eligible for Stage A, had to demonstrate active disease with clinically meaningful worsening on at least one CIDP clinical assessment tool, including INCAT, I-RODS, or mean grip strength. Treatment-naïve patients were able to skip the run-in period with proof of recent worsening. To advance to Stage B, patients needed to demonstrate evidence of clinical improvement (ECI) with efgartigimod alfa SC. ECI was achieved through improvement of the INCAT score, or improvement on I- RODS or mean grip strength if those scales had demonstrated worsening during the run-in period. In Stage B, patients were randomized to either efgartigimod alfa SC or placebo for up to 48 weeks. The primary endpoint was measured once 88 total relapses or events were achieved in Stage B and was based on the hazard ratio for the time to first adjusted INCAT deterioration (i.e. relapse). After Stage B, all patients had the option to roll-over to an open-label extension study to receive efgartigimod alfa SC. About Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)CIDP is a rare and serious autoimmune disease of the peripheral nervous system. There is increasing evidence that IgG antibodies play a key role in the damage to the peripheral nerves. People with CIDP experience fatigue, muscle weakness and a loss of feeling in their arms and legs that can worsen over time or may come and go. These symptoms can significantly impair a person's ability to function in their daily lives. Without treatment, one-third of people living with CIDP will need a wheelchair. About Efgartigimod SCEfgartigimod SC (efgartigimod alfa) is a human IgG1 antibody fragment designed to reduce pathogenic immunoglobulin G (IgG) antibodies by binding to the neonatal Fc receptor (FcRn) and blocking the IgG recycling process. Efgartigimod SC is the first-approved FcRn blocker globally and is marketed as VYVGART® Hytrulo in the United States and China for the treatment of generalized myasthenia gravis (gMG) and CIDP; as VYVDURA in Japan for gMG and CIDP; and as VYVGART for gMG and CIDP in other regions globally. Efgartigimod SC is currently being evaluated in more than 15 severe autoimmune diseases where pathogenic IgGs are believed to be mediators of disease. About argenxargenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercialising the first approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit and follow us on LinkedIn, Instagram, Facebook, and YouTube. Contacts Media:Kate Dion kdion@ Investors: Alexandra Royaroy@ Forward-Looking Statements The contents of this announcement include statements that are, or may be deemed to be, 'forward-looking statements.' These forward-looking statements can be identified by the use of forward-looking terminology, including the terms 'aim,' 'is,' 'can,' 'may,' 'will,' and 'believe' and include statements argenx makes concerning argenx's aim to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines; its belief that the approval of VYVGART SC for the treatment of CIDP may bring meaningful functional improvements to patients; the timing of access to an effective novel therapy for CIDP patients and physicians across Europe; and the potential of efgartigimod in IgG-mediated autoimmune diseases. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx's actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including but not limited to, the results of argenx's clinical trials; expectations regarding the inherent uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development activities and regulatory approval requirements; the acceptance of its products and product candidates by its patients as safe, effective and cost-effective; the impact of governmental laws and regulations, including tariffs, export controls, sanctions and other regulations on its business; its reliance on third-party suppliers, service providers and manufacturers; inflation and deflation and the corresponding fluctuations in interest rates; and regional instability and conflicts. A further list and description of these risks, uncertainties and other risks can be found in argenx's U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx's most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
10-06-2025
- Business
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argenx Presents New Efgartigimod Data at EULAR 2025 Highlighting Positive Phase 2 Proof-of-Concept Results in Myositis and Sjogren's Disease
ALKIVIA data demonstrate significant improvement in muscle strength and physical function in myositis patients treated with efgartigimod RHO data show efgartigimod achieved sustained reduction in autoantibodies and improved functional outcomes in patients with Sjogren's disease; program granted U.S. FDA Fast Track designation argenx committed to new therapeutic areas in rheumatology with ongoing Phase 3 studies in myositis (ALKIVIA) and Sjogren's disease (UNITY) June 11, 2025, 12:01 AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced the presentation of positive results from Phase 2 studies evaluating VYVGART® (IV: efgartigimod alfa-fcab and SC or Hytrulo: efgartigimod alfa and hyaluronidase-qvfc) in Sjogren's disease (SjD) and idiopathic inflammatory myopathies (IIM or myositis) at the European Congress of Rheumatology, EULAR 2025, from June 11 – 14 in Barcelona, Spain. argenx also announced that the U.S. Food and Drug Administration (FDA) has granted efgartigimod Fast Track designation (FTD) for the treatment of primary Sjogren's disease. 'Our innovation model prioritizes strong biologic rationale and efficient clinical program design, which enables us to rapidly advance development in rheumatic diseases,' said Luc Truyen, M.D., Ph.D., Chief Medical Officer, argenx. 'The accumulating body of evidence about the role of IgG autoantibodies reinforces the therapeutic potential of efgartigimod as a new approach for treating several rheumatic diseases – aiming to go beyond symptom management by targeting the underlying disease. The data presented at EULAR highlight efgartigimod's potential as a precision therapy for patients living with myositis and Sjogren's disease, and we are hopeful this novel treatment will offer a new therapeutic option and lead to improved outcomes for patients.' ALKIVIA Data Show Efgartigimod Provides Functional Improvement in Patients with Myositis Consistent and statistically significant treatment effect: In the ongoing, seamless ALKIVIA Phase 2/3 study evaluating three myositis subtypes (IMNM, ASyS, DM), data from Phase 2 show that patients demonstrated significant improvement in muscle strength and physical function when treated with efgartigimod. The study's primary endpoint, mean Total Improvement Score (TIS) at 24 weeks, is a composite of six core measures of disease activity and muscle function. TIS improvement was observed in a majority of efgartigimod-treated patients across all six core measures, and the primary endpoint was met. Efgartigimod patients showed a significantly higher mean TIS of 50.45 compared to 35.65 in the placebo arm (2-sided P=0.0004). In addition, for patients treated with efgartigimod, 79% achieved a moderate improvement (TIS ≥40) and 34% achieved a major improvement (TIS ≥60), compared to 47% and 9.5% respectively of patients receiving placebo. Favorable Time to TIS and Safety Profile: Among the study's secondary endpoints, patients receiving efgartigimod improved significantly faster than patients receiving placebo, leading to a median time to minimal improvement (TIS ≥20) of 30 days and time to moderate improvement (TIS ≥40) of 16 weeks. Comparatively, patients in the placebo arm reached minimal improvement (TIS ≥20) in 72 days, while there was no majority of placebo patients reaching moderate improvement (TIS ≥40) at any point in the 24-week study. Efgartigimod was well-tolerated and the proportion of patients experiencing at least one treatment-emergent adverse event (TEAE) was similar in the efgartigimod and placebo arms. Evaluation of efgartigimod in myositis is ongoing in the Phase 3 portion of the ALKIVIA study. 'Myositis is a debilitating disease that can cause muscle weakness, affect multiple organs, and have a severe impact on patients' quality of life. Physicians struggle to treat it because current options are limited and have significant side effects,' said Hector Chinoy, Ph.D., ALKIVIA study investigator and Professor of Rheumatology and Neuromuscular Disease at The University of Manchester. 'Results from this study, the first of an FcRn inhibitor in myositis, demonstrate the potential of a transformative targeted treatment approach. Efgartigimod was well-tolerated and led to significant improvements compared to placebo, offering new hope for a treatment that targets autoantibodies as one of the potential key drivers of disease.' RHO Data Show Efgartigimod's Clinical Effect Across Endpoints in Sjogren's Disease Improved systemic disease activity and reduction in symptoms: In the Phase 2 proof-of-concept RHO study, efgartigimod showed significant improvement in systemic disease activity and patient symptoms. 45.5% of patients receiving efgartigimod achieved improved outcomes on the CRESS composite primary endpoint at Week 24 – including systemic disease activity, salivary and tear gland function – compared to 11.1% among patients treated with placebo. Improvements among patients treated with efgartigimod were achieved in 4 out of 5 CRESS measures. In addition, disease activity among patients treated with efgartigimod showed a median change in clinESSDAI total score of -7.0 versus -4.0 in the placebo arm. A key secondary endpoint is the cSTAR composite of five disease measures, which showed patients treated with efgartigimod achieved a 54.5% response versus 33.3% in the placebo arm. Potential for disease biology modulation: Biomarker response in RHO study also demonstrated rapid and sustained reduction of IgG with a ~60% reduction from Week 4 onwards. The efgartigimod group showed notable decreases in the disease-associated antibodies anti-Ro52 (-57% vs +13%) and Rheumatoid Factor (-26.6% vs -5.3%), as well as reduction in C1Q immune complexes (-4.5 vs -0.06 mc eq/mL) compared to placebo. Efgartigimod demonstrated a favorable safety profile among patients with Sjogren's disease. The observed safety and tolerability was consistent with other clinical trials, with no new safety signals observed. The Phase 3 UNITY trial is currently ongoing to assess efficacy and safety of efgartigimod in patients with moderate to severe Sjogren's disease. 'These data suggest that targeting FcRn and reducing IgGs has a meaningful impact on Sjogren's disease,' said Isabelle Peene M.D., Ph.D., study investigator, Department of Rheumatology, Ghent University Hospital. 'The clinical and biomarker findings add to our growing understanding of IgG autoantibodies in Sjogren's disease and could inform future treatment strategies for this complex, progressive and underserved condition.' More information on the data presented at the EULAR 2025 meeting can be found for presentations are as follows: Title Presenter Presentation Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants with Active Idiopathic Inflammatory Myopathy: Phase 2 Results from the ALKIVIA Study Hector Chinoy Oral Presentation #OP0002Session: Abstract PlenaryWednesday, June 1116:40-16:50 CEST Treatment of Sjögren's disease by blocking FcRn: clinical and translational data from Rho, a phase 2 randomized, placebo controlled, double-blind, proof-of-concept study with efgartigimod Isabelle Peene Oral Presentation #OP0041Session: Clinical AbstractWednesday, June 1116:30-16:40 CEST Efficacy and safety of efgartigimod PH20 subcutaneous by prefilled syringe in adults with Sjögren's disease: A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial with open-label extension (UNITY) Simon Bowman Poster #POS0844Poster View IIIThursday, June 1212:00-13:30 CEST Safety, tolerability, and efficacy of empasiprubart in adults with dermatomyositis (EMPACIFIC): A Phase 2, randomized, double-blind, placebo-controlled, multicenter study Tetyana Storie Poster #POS1049Poster View VIFriday, June 1312:00-13:30 CEST ALKIVIA Study DesignThe ALKIVIA study is a randomized, double-blind, placebo-controlled, multicenter, operationally seamless Phase 2/3 study of efgartigimod SC for the treatment of idiopathic inflammatory myopathies (IIM or myositis) across three subtypes, including immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS), and dermatomyositis (DM). The ALKIVIA study enrolled 240 patients in total and is being conducted in two phases, with an analysis of the Phase 2 portion of the clinical trial after the first 90 patients completed the study, followed by a Phase 3 portion if a signal is observed in the Phase 2 portion. The primary endpoint is the mean total improvement score (TIS) at the end of the treatment period (24 weeks in Phase 2 and 52 weeks in Phase 3) of all treated patients (IMNM, ASyS, DM) compared to placebo. Key secondary endpoints include response rates at the end of treatment, time to response, and duration of response in TIS, as well as change from baseline in individual TIS components. Other secondary endpoints include quality of life and other functional scores. About Idiopathic Inflammatory MyopathiesIdiopathic inflammatory myopathies (myositis) are a rare group of autoimmune diseases that can be muscle specific or affect multiple organs including the skin, joints, lungs, gastrointestinal tract and heart. Myositis can be very severe and disabling and have a material impact on quality of life. Initially, myositis was classified as either DM or polymyositis, but as the underlying pathophysiology of myositis has become better understood, including through the identification of characteristic autoantibodies, new polymyositis subtypes have emerged. Two of these subtypes are IMNM and ASyS. Proximal muscle weakness is a unifying feature of each subtype. IMNM is characterized by skeletal muscle weakness due to muscle cell necrosis. ASyS is characterized by muscle inflammation, inflammatory arthritis, interstitial lung disease, thickening and cracking of the hands ('mechanic's hands') and Raynaud's phenomenon. DM is characterized by muscle inflammation and degeneration and skin abnormalities, including heliotrope rash, Gottron's papules, erythematous, calcinosis and edema. RHO Study DesignThe Phase 2 RHO study was a randomized, double-blinded, placebo-controlled multicenter proof of concept study to evaluate the safety and efficacy of efgartigimod in adults with Sjogren's Disease. In order to enter the study, patients needed to test positive for anti-Ro autoantibodies and maintain residual salivary flow. Thirty four patients were randomized 2:1 to receive either efgartigimod or placebo for up to 24 weeks. Multiple endpoints and biomarkers were evaluated in the signal-finding study, including the primary endpoint of CRESS (Composite of Relevant Endpoints for Sjogren's Syndrome). Within CRESS there are five components spanning: systemic disease activity as measured by the ESSDAI (EULAR Sjogren's Syndrome Activity Index), patient reported outcomes as measured by the ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index), tear and salivary gland function and serology. To be a CRESS responder, patients needed to demonstrate a clinically meaningful benefit in at least 3 of the 5 composite items. Additional datapoints were gathered including the clinESSDAI, STAR (Sjogren's Tool for Assessing Response), biomarker data, and the change in lymphocytic infiltrate levels through parotid biopsies. About Sjogren's DiseaseSjogren's Disease (SjD) is a chronic, slowly progressive inflammatory systemic autoimmune disease characterized by immune-mediated destruction of exocrine glands. SjD can be severely debilitating and have a negative impact on patient quality of life, with common symptoms reported as dry eyes and mouth, fatigue, and joint point. In addition, a substantial subset of patients suffer from extraglandular systemic disease. While the presence of anti-Ro and anti-La IgG autoantibodies are considered a hallmark of disease, the underlying cause of SjD is believed to be multi-factorial, triggered by environmental factors, leading to autoimmunity and chronic inflammation. SjD predominantly impacts women with a 9:1 female:male incidence ratio. Given the heterogeneous nature of the disease, the treatment journey can be challenging with long delays and high rates of misdiagnosis. There are no FDA- approved treatments targeting the disease itself, leaving current treatments to focus primarily on individual symptom management. About EfgartigimodEfgartigimod (efgartigimod alfa and hyaluronidase-qvfc) is a human IgG1 antibody fragment designed to reduce pathogenic immunoglobulin G (IgG) antibodies by binding to the neonatal Fc receptor (FcRn) and blocking the IgG recycling process. Efgartigimod is the first-approved FcRn blocker globally and is marketed as VYVGART® and VYVGART® Hytrulo in the United States and China for the treatment of generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP), and as VYVDURA (Japan) or VYVGART SC for gMG in other regions globally. Efgartigimod is currently being evaluated in more than 15 severe autoimmune diseases where pathogenic IgGs are believed to be mediators of disease. About argenxargenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit and follow us on LinkedIn, Instagram, Facebook, and YouTube. For further information, please contact: Media: Colin McBeancmcbean@ Investors: Alexandra Royaroy@ Forward-looking Statements The contents of this announcement include statements that are, or may be deemed to be, 'forward-looking statements.' These forward-looking statements can be identified by the use of forward-looking terminology, including the terms 'aim,' 'are,' 'believe,' 'can,' 'commit,' and 'will' and include statements argenx makes concerning its commitment to improving the lives of people suffering from severe autoimmune diseases and to new therapeutic areas in rheumatology; the discussion of its Phase 2 proof-of-concept results as well as the ongoing Phase 3 studies for efgartigimod in myositis and Sjogren's disease at EULAR 2025, including the planned agenda of such congress; its ability to rapidly advance development in rheumatic diseases; its goal to have efgartigimod not just manage symptoms but target the underlying disease and its potential as a precision therapy for myositis and Sjogren's patients; the potential for efgartigimod to be a transformative targeted treatment approach; and its hope that efgartigimod leads to improved outcomes and offer a new therapeutic options for such patients. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx's actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including but not limited to, the results of argenx's clinical trials; expectations regarding the inherent uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development activities and regulatory approval requirements; the acceptance of its products and product candidates by its patients as safe, effective and cost-effective; the impact of governmental laws and regulations, including tariffs, export controls, sanctions and other regulations on its business; its reliance on third-party suppliers, service providers and manufacturers; inflation and deflation and the corresponding fluctuations in interest rates; and regional instability and conflicts. A further list and description of these risks, uncertainties and other risks can be found in argenx's U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx's most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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09-06-2025
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High Growth Tech Stocks To Watch In Europe June 2025
As the European markets experience a boost, with the STOXX Europe 600 Index climbing by 0.90% amid easing inflation and supportive monetary policy from the European Central Bank, investors are increasingly focusing on high-growth sectors such as technology. In this environment, identifying promising tech stocks involves looking for companies that can leverage favorable economic conditions and technological advancements to drive substantial growth. Name Revenue Growth Earnings Growth Growth Rating Intellego Technologies 30.80% 45.66% ★★★★★★ Archos 21.07% 36.58% ★★★★★★ KebNi 21.51% 66.96% ★★★★★★ Pharma Mar 29.61% 44.92% ★★★★★★ Bonesupport Holding 29.14% 56.14% ★★★★★★ argenx 21.50% 26.61% ★★★★★★ Skolon 31.51% 99.52% ★★★★★★ Xbrane Biopharma 24.95% 56.77% ★★★★★★ Diamyd Medical 86.29% 93.04% ★★★★★★ Elliptic Laboratories 36.33% 78.99% ★★★★★★ Click here to see the full list of 226 stocks from our European High Growth Tech and AI Stocks screener. Let's explore several standout options from the results in the screener. Simply Wall St Growth Rating: ★★★★★★ Overview: argenx SE is a commercial-stage biopharma company focused on developing therapies for autoimmune diseases across several countries including the United States, Japan, China, and the Netherlands, with a market cap of €31.52 billion. Operations: argenx focuses on developing therapies for autoimmune diseases, generating revenue primarily from its biotechnology segment, which reported $2.64 billion. The company's operations span multiple countries, including the United States, Japan, China, and the Netherlands. argenx SE has demonstrated remarkable growth with a surge in revenue to $807.37 million, doubling from the previous year's $412.51 million, alongside transitioning from a net loss to a substantial net income of $169.47 million. This financial turnaround is underscored by robust R&D commitments, crucial for sustaining innovation and competitiveness in the biotech landscape. The firm's recent CHMP nod for VYVGART® in CIDP treatment further highlights its strategic focus on expanding therapeutic applications, promising continued relevance and impact within the healthcare sector. Click here to discover the nuances of argenx with our detailed analytical health report. Understand argenx's track record by examining our Past report. Simply Wall St Growth Rating: ★★★★☆☆ Overview: Believe S.A. is a company that offers digital music services to independent labels and local artists across various regions including France, Germany, the rest of Europe, the Americas, Asia, Oceania, and the Pacific with a market cap of approximately €1.72 billion. Operations: The company's revenue primarily comes from Premium Solutions, generating €924.24 million, while Automated Solutions contribute €64.59 million. Believe, a European tech entity, is navigating its path towards profitability with expected earnings growth of 96.9% annually. Despite current unprofitability, its revenue growth outpaces the French market's average at 13.4% per year compared to 5%. This growth trajectory is supported by strategic moves such as the proposed acquisition by TCMI Inc., EQT X, and Denis Ladegaillerie for a €57.9 million stake, enhancing financial stability and market presence. Moreover, Believe's commitment to R&D aligns with industry demands for continuous innovation, ensuring it remains competitive in the dynamic tech landscape. Get an in-depth perspective on Believe's performance by reading our health report here. Examine Believe's past performance report to understand how it has performed in the past. Simply Wall St Growth Rating: ★★★★★☆ Overview: Comet Holding AG, along with its subsidiaries, delivers X-ray and radio frequency (RF) power technology solutions globally across Europe, North America, and Asia, with a market capitalization of CHF1.79 billion. Operations: The company generates revenue through three main segments: X-Ray Systems (CHF115.89 million), Industrial X-Ray Modules (CHF94.57 million), and Plasma Control Technologies (CHF247.39 million). Comet Holding AG, a Swiss tech firm, is making notable strides with an earnings growth of 37.3% annually, significantly outpacing the local market's average of 10.7%. This robust performance is further underscored by its revenue increase of 12.2% per year, which also surpasses the Swiss market growth rate of 4.2%. Notably, Comet's commitment to innovation is evident in its R&D spending, crucial for maintaining technological leadership in a competitive sector. Recent corporate actions include electing Benjamin Loh as Chairman and approving a dividend increase to CHF 1.50 per share, signaling strong governance and shareholder confidence amidst a promising financial trajectory marked by first-quarter sales surging by 37.5% year-over-year to CHF 111.2 million. Take a closer look at Comet Holding's potential here in our health report. Assess Comet Holding's past performance with our detailed historical performance reports. Dive into all 226 of the European High Growth Tech and AI Stocks we have identified here. Shareholder in one or more of these companies? Ensure you're never caught off-guard by adding your portfolio in Simply Wall St for timely alerts on significant stock developments. Join a community of smart investors by using Simply Wall St. It's free and delivers expert-level analysis on worldwide markets. Explore high-performing small cap companies that haven't yet garnered significant analyst attention. Fuel your portfolio with companies showing strong growth potential, backed by optimistic outlooks both from analysts and management. Find companies with promising cash flow potential yet trading below their fair value. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include ENXTBR:ARGX ENXTPA:BLV and SWX:COTN. Have feedback on this article? Concerned about the content? with us directly. 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Yahoo
06-06-2025
- Business
- Yahoo
argenx SE (ARGX): A Bull Case Theory
We came across a bullish thesis on argenx SE (ARGX) by Simvestor08 on r/valueinvesting on Reddit.. In this article, we will summarize the bulls' thesis on ARGX. argenx SE (ARGX)'s share was trading at $573.26 as of 30th May. ARGX's trailing and forward P/E were 34.93 and 59.88 respectively according to Yahoo Finance. A laboratory technician researching a sample of cells in a biotechnology laboratory. Argenx (ARGX), a $35 billion biotech company dual-listed on Nasdaq and Belgium's BEL 20, presents a highly compelling investment case with strong upside potential, backed by a proven management team and a deep pipeline. Despite broader sector pressures, including political noise related to Trump and general weakness across pharma, Argenx remains well-positioned for sustained growth. The company is already profitable and boasts a commercialized multi-blockbuster drug, with several late-stage candidates in its pipeline. Guggenheim recently assigned a $1,065 price target—nearly double the current ~$573 share price—highlighting the potential of Argenx's upcoming Phase 2 and Phase 3 readouts, which are largely derisked with estimated success probabilities ranging from 70% to 90%. Beyond its pipeline strength, Argenx is widely respected for its disciplined and focused leadership, a quality that has been consistently noted across the biotech community. In 2023, Bloomberg reported that Argenx engaged JP Morgan to explore strategic options, including a potential takeover, following the release of positive Phase 3 data for CIDP—an indication with peak sales projected at $4–5 billion. The company's business model is also structurally resilient to political risk; it maintains a tight pricing corridor between the US and Europe and manufactures its US-sold products domestically, minimizing exposure to drug pricing reforms or supply chain disruptions. While the recent downturn in pharma dragged ARGX's valuation lower, the fundamentals remain intact, and with multiple catalysts on the horizon, a doubling of the share price within 12 to 24 months appears feasible for long-term investors. Previously, we have covered ARGX in May 2025 wherein we summarized a bullish thesis by FluentInQuality on Substack. The author highlighted the company's transformation into a platform biotech leveraging FcRn inhibition to systematically expand into chronic autoimmune indications, anchored by its flagship therapy, Vyvgart. The article emphasized that despite strong revenue growth, a deep pipeline, and strategic global expansion, the market had undervalued argenx's long-term potential and M&A appeal. argenx SE (ARGX) is not on our list of the 30 Most Popular Stocks Among Hedge Funds. As per our database, 54 hedge fund portfolios held ARGX at the end of the first quarter which was 47 in the previous quarter. While we acknowledge the potential of ARGX as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, see our free report on the best short-term AI stock. READ NEXT: 8 Best Wide Moat Stocks to Buy Now and 30 Most Important AI Stocks According to BlackRock. Disclosure: None. This article was originally published at Insider Monkey. Sign in to access your portfolio
Yahoo
15-05-2025
- Business
- Yahoo
argenx SE (ARGX): Among the Best Growth Stocks to Buy and Hold for the Long Term
We recently compiled a list of the . In this article, we are going to take a look at where argenx SE (NASDAQ:ARGX) stands against the other growth stocks. The market closed last week mostly lower, however, the S&P 500 has been up more than 7% since April 11, indicating a returning positive sentiment. On May 10, David Lefkowitz, Equity Strategist at UBS Global Wealth Management, joined CNBC to discuss his bull case for the US equities. Lefkowitz acknowledged the volatility that has been around since the tariff announcement; however, he believes that backdrop remains fairly constructive. He elaborated that the market has had some significant buy signals since early April, characterised by the volatility index giving one of the highest readings, investor sentiment being cautious, and investor positioning has been depressed. Historically speaking, whenever these things have happened in the past, the US equities have performed exceptionally well in the preceding 6 to 12 months. Lefkowitz noted that he is not too concerned with the day-to-day news and volatility, as the market will get choppy on trade negotiation deals. Rather, he is more focused on the bigger picture, which indicates that stocks will ultimately end up higher over the next 12 months. While answering a question regarding the recent rebound in the market, Lefkowitz highlighted that when the volatility index comes down, as it has over the past few weeks, history tells us that the market does not make new lows. Although the market will still be chopping a little. However, it is anticipated to stay within the historic average of 5%. Moreover, the equity strategist is also not concerned about the valuations and believes that as soon as the companies start posting earnings growth, the backdrop will help the market reach its next high. While talking about his most convicted sectors, Lefkowitz noted that he likes secular growth stocks. He elaborated that growth as a sector was hit earlier this year due to doubts regarding AI trends and its ability to generate a return on investment. This has resulted in the sector being at the bottom of the market. However, Lefkowitz believes that the demand for AI products and the sophisticated infrastructure will keep growing for at least the next few years, thereby generating sustainable earnings growth. To compile the list of 12 best growth stocks to buy and hold for the long term, we used the Finviz stock screener, Seeking Alpha, and Insider Monkey's Q4 2024 hedge fund database. Using the screener, we aggregated a list of growth stocks that have grown their sales by at least 30% over the past 5 years. Next, we cross-checked the 5-year sales growth for each stock from Seeking Alpha and ranked the stocks in ascending order of the number of hedge fund investors. Why are we interested in the stocks that hedge funds pile into? The reason is simple: our research has shown that we can outperform the market by imitating the top stock picks of the best hedge funds. Our quarterly newsletter's strategy selects 14 small-cap and large-cap stocks every quarter and has returned 373.4% since May 2014, beating its benchmark by 218 percentage points (). A lab setting filled with scientific equipment and researchers in lab coats working together to develop new therapies for autoimmune diseases. argenx SE (NASDAQ:ARGX) is a commercial-stage biotechnology company that focuses on developing antibody therapeutics for autoimmune diseases and cancer. It uses its proprietary discovery platform to leverage unique characteristics of the llama immune system and engineer antibody medicines. Its lead products, VYVGART and VYVGART HYTRULO, are approved in the United States, Europe, and Japan. On May 9, Douglas Tsao, an analyst at H.C. Wainwright, reiterated a Buy rating on the stock with a price target of $720. The analyst noted the company grew net product sales for VYVGART, which exceeded market expectations. The company reported its fiscal first quarter results for 2025 on May 8. Management noted that it generated a total operating income of $807 million, driven primarily by $790 million in product net sales, which represents a 99% increase compared to the same quarter in the previous year. The product sales of argenx SE (NASDAQ:ARGX) were geographically diversified, with the majority of sales coming from the US. The analyst, Tsao, noted that the upcoming launch of Vyvgart's prefilled syringe (PFS), expected to improve patient accessibility and convenience. Management of the company also expects that the self-injection is expected to further expand patient access by enabling easier self-administration and reaching new patient populations. argenx SE (NASDAQ:ARGX) ranks as one of the best growth stocks to buy and hold for the long term. Artisan Small Cap Fund stated the following regarding argenx SE (NASDAQ:ARGX) in its Q4 2024 investor letter: 'We ended our investment campaigns in argenx SE (NASDAQ:ARGX), Tyler Technologies and Interparfums. Shares of Argenx have continued their year-to-date ascent due to multiple positive developments, including FDA approval to promote VYVGART® for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and strong sales execution of VYVGART®'s first approved indication in myasthenia gravis. While we continue to have high conviction, the company has outgrown our small-cap mandate, and we exited our position after a successful multiyear investment campaign.' Overall ARGX ranks 9th on our list of the best growth stocks to buy and hold for the long term. While we acknowledge the potential of ARGX as an investment, our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. There is an AI stock that went up since the beginning of 2025, while popular AI stocks lost around 25%. If you are looking for an AI stock that is more promising than ARGX but that trades at less than 5 times its earnings, check out our report about this . READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey.
