Belgian-Dutch pharmaceutical company specializing in immunology and antibody therapies for autoimmune diseases and cancer, with a focus on orphan drug development. Dual-headquartered in Ghent, Belgium and Breda, Netherlands; listed on Euronext Brussels (ARGX) and Nasdaq.
Clinical Trials
133
26 active
Approvals
3
Total approvals
Agencies
1
Regulatory bodies
Founded
2008
Active, not recruiting
18
13.5%
Available
1
0.8%
Completed
41
30.8%
Enrolling By Invitation
2
1.5%
Not yet recruiting
6
4.5%
Recruiting
57
42.9%
Terminated
7
5.3%
Withdrawn
1
0.8%
- Sling Therapeutics raised a $123 million Series C led by Forbion to fund a late-stage trial of its oral thyroid eye disease drug linsitinib. - The global Phase 3 'Orbit' study will enroll about 130 adults with moderate-to-severe active TED, dosed at 150 mg or placebo twice daily for 24 weeks. - An earlier late-stage trial showed a statistically significant 52% response rate at 24 weeks with no drug-related hearing loss or tinnitus reported. - If approved, linsitinib would be the first oral therapy for TED, offering an alternative to injected IGF-1R antibodies Tepezza and Lumvoa.
- BenchSci announced a two-year enterprise agreement with argenx to deploy EMET, its agentic research environment for preclinical drug discovery, across argenx's global research organization. - The platform was selected through a competitive evaluation led by argenx's own scientists, marking a significant milestone in BenchSci's expansion across European biopharma. - EMET unifies data, models, software, workflows, and scientific reasoning, reasoning across 38M+ publications and 100+ curated databases to support preclinical, computational, and drug development workflows. - argenx will test whether always-on scientific support can meaningfully accelerate preclinical development and broader computational and drug development workflows.
- PM360 has named Alex Gorsky, former Chairman and CEO of Johnson & Johnson, as its 2026 Lifetime Achievement Award honoree, recognizing his leadership across the company's Pharmaceutical, Medical Device, and Consumer businesses. - Lina Polimeni, Senior Vice President and Chief Marketing Officer—Consumer at Eli Lilly and Company, has been selected as PM360's inaugural Chief Marketing Officer of the Year. - The honorees, along with 31 Brand Champions and over 100 finalists across nine categories, will be celebrated at the 18th Annual Trailblazer Awards Gala on September 29 at Gotham Hall in New York City. - The Trailblazer Awards, established in 2009, recognize innovation and measurable impact in life sciences marketing, with winners selected by the PM360 Editorial Advisory Board.
- Judy and Stewart Colton's $15 million gift will be shared across NYU Langone, Yale University, and Tel Aviv University to advance collaborative autoimmune disease research. - The Colton Consortium enables real-time sharing of ideas, technologies, patient cohorts, and expertise to predict optimal treatments for individual patients. - NYU Langone's Colton Center pursues translational research integrating clinical care, immunology, genetics, microbiome science, and data-driven discovery across multiple immune-mediated diseases. - Prior Colton-funded work has already yielded a successful research partnership with biopharmaceutical company argenx, demonstrating the program's impact on drug development.
- An international research consortium led by VIB and Ghent University has developed a novel genetically engineered mouse model that accurately replicates human Fc gamma receptor biology, addressing critical limitations in antibody drug testing. - The platform solves the problem of species differences in immune responses that have led to costly late-stage clinical failures and unexpected safety issues, including dangerous blood clotting risks that were previously undetectable in standard preclinical models. - The new system enables head-to-head comparisons of antibody variants and provides more reliable early-stage data, potentially reducing development costs and accelerating delivery of effective treatments to patients. - Published in Science Immunology, this breakthrough aligns with FDA expectations for more sophisticated preclinical models and represents a collaboration between VIB-Ghent University, argenx, genOway, and Innate Pharma.
- argenx announced that current COO Karen Massey will transition to CEO while co-founder Tim Van Hauwermeiren moves to Chairman of the Board of Directors. - The leadership changes are subject to shareholder approval at the Annual General Meeting on May 6, 2026, allowing for a comprehensive transition period. - Van Hauwermeiren praised Massey's exceptional impact over three years, including accelerating VYVGART's launch and building the company's commercial engine. - The transition marks the next phase of growth for the global immunology company as it works toward its Vision 2030 objectives.
- Zai Lab announced the successful renewal of VYVGART, NUZYRA, and ZEJULA in China's 2025 National Reimbursement Drug List, ensuring continued patient access to these innovative therapies. - The company now has six products included on the NRDL, significantly reducing disease burden by enabling broad patient access to high-quality medicines for serious conditions. - VYVGART treats generalized myasthenia gravis affecting approximately 170,000 Chinese patients, while NUZYRA addresses bacterial infections with 10 million CABP cases annually. - ZEJULA provides maintenance therapy for ovarian cancer patients, addressing a critical need given over 55,000 new cases and 37,000 deaths annually in China.
- AstraZeneca's gefurulimab achieved a statistically significant 1.6-point improvement in MG-ADL scores compared to placebo in the Phase III PREVAIL study for generalized myasthenia gravis. - The complement 5 inhibitor demonstrated inferior efficacy compared to rival therapies, including UCB's Rystiggo which showed up to 2.6-point MG-ADL improvements and AstraZeneca's own Soliris and Ultomiris. - Gefurulimab showed favorable safety profile with mild-to-moderate adverse events and offers subcutaneous administration, potentially positioning it to compete in the $6.1 billion gMG market as treatment paradigms shift toward self-administered therapies.
- Novartis reported positive Phase III VAYHIT2 trial results showing ianalumab plus eltrombopag prolonged immune thrombocytopenia disease control by 45% compared to placebo. - The combination therapy achieved a median time to treatment failure of 13.0 months, 2.8 times longer than the 4.7 months observed with placebo plus eltrombopag. - Multiple pharmaceutical companies are advancing ITP treatments through clinical trials, with over 30 companies developing 30+ pipeline therapies for this autoimmune bleeding disorder. - Recent clinical trial initiations include studies by Incyte, argenx, and Eli Lilly evaluating novel therapeutic approaches for primary immune thrombocytopenia.
- Argenx has expanded its strategic partnership with Fujifilm Biotechnologies to initiate manufacturing of efgartigimod drug substance at the Holly Springs, North Carolina site beginning in 2028. - The collaboration marks Fujifilm Biotechnologies' first global end-to-end program utilizing its kojoX modular network, providing local-for-local supply across the U.S., U.K., Denmark, and Japan. - Efgartigimod is a monoclonal antibody fragment targeting the neonatal Fc receptor, approved globally for treating generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy. - The partnership will strengthen supply chain resilience and enable manufacturing medicines in the U.S. for American patients while supporting broader global reach.
