This week, the biotech space witnessed significant milestones, including FDA approvals, oncology drug acquisitions, and collaborations. Positive clinical trial results were reported across multiple therapeutic areas, including radiographic and non-radiographic axial spondyloarthritis, microcystic lymphatic malformations, pulmonary arterial hypertension, and obesity. Here's a closer look at the details. FDA Approvals & Rejections Armata Pharma Secures FDA QIDP Designation for AP-SA02 Armata Pharmaceuticals, ...

Argenx SE (NASDAQ:ARGX) on Thursday reported upbeat fourth-quarter results and announced positive topline results from the Phase 3 ADAPT OCULUS study evaluating VYVGART in adults with ocular myasthenia gravis (oMG).Argenx reported fourth-quarter earnings of $8.02 per share, beating the consensus of $6.02. Sales jumped from $761.2 million to $1.32 billion, surpassing the consensus estimate of $1.29 billion.“Argenx delivered another standout year of execution in 2025,” said Tim Van Hauwermeiren, CEO of Argenx ...

Argenx SE (NASDAQ:ARGX) on Thursday reported upbeat fourth-quarter results and announced positive topline results from the Phase 3 ADAPT OCULUS study evaluating VYVGART in adults with ocular myasthenia gravis (oMG).Argenx reported fourth-quarter earnings of $8.02 per share, beating the consensus of $6.02. Sales jumped from $761.2 million to $1.32 billion, surpassing the consensus estimate of $1.29 billion.“Argenx delivered another standout year of execution in 2025,” said Tim Van Hauwermeiren, CEO of Argenx ...

In Q&A, Massey referenced prior company estimates that seronegative MG could expand the addressable population by about 11,000 patients and ocular MG by about 7,000 patients, noting the ocular figure represented those believed eligible for VYVGART based on market research rather than the entire ocular MG population.Chief Operating Officer Karen Massey said the company views the ADAPT OCULUS results as a “meaningful opportunity” to broaden VYVGART’s reach in MG alongside progress in seronegative MG. She reit ...

argenx (NasdaqGS:ARGX) Q4 2025 Earnings call February 26, 2026 08:30 AM ET Company ParticipantsAkash Tewari - Global Head of Biopharmaceutical ResearchAlex Thompson - Managing DirectorBeth DelGiacco - VP of Corporate AffairsDanielle Brill - Managing DirectorDouglas Tsao - Managing DirectorJames Gordon - Director and Head of European PharmaJustin Smith - DirectorKaren Massey - COOKarl Gubitz - CFOLuc Truyen - Chief Medical OfficerMatt Phipps - Partner and Group Head of BiotechnologyRajan Sharma - Executive D ...

argenx (NasdaqGS:ARGX) Q4 2025 Earnings call February 26, 2026 08:30 AM ET Company ParticipantsAkash Tewari - Global Head of Biopharmaceutical ResearchAlex Thompson - Managing DirectorBeth DelGiacco - VP of Corporate AffairsDanielle Brill - Managing DirectorDouglas Tsao - Managing DirectorJames Gordon - Director and Head of European PharmaJustin Smith - DirectorKaren Massey - COOKarl Gubitz - CFOLuc Truyen - Chief Medical OfficerMatt Phipps - Partner and Group Head of BiotechnologyRajan Sharma - Executive D ...

Argenx SE (NASDAQ:ARGX) on Thursday announced positive topline results from the Phase 3 ADAPT OCULUS study evaluating VYVGART in adults with ocular myasthenia gravis (oMG).It is an autoimmune disorder where antibodies disrupt nerve-muscle communication, causing variable, fatiguing weakness of eye muscles and eyelids (ptosis) and double vision (diplopia).The study met its primary endpoint, demonstrating statistically significant improvement in patient-reported outcomes.Argenx Says Vyvgart Improves Double Vis ...

Certain statements contained in this presentation, other than present and historical facts and conditions independently verifiable at the date hereof, may constitute forward-looking statements. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "advance," "broaden," "build," "deliver," and "expand," and include statements argenx makes regarding its new era of innovation in immunology; its advancement of its Vision 2030, including (1) 5 new molec ...

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Financial Performance - Company reported $1.3 billion in global product net sales for the fourth quarter and $4.2 billion for the full year 2025, representing a 90% year-over-year growth [1][19] - Operating income reached $1.1 billion in 2025, marking the first year of operating profitability [1] - Profit for the year was $1.3 billion, compared to $833 million in 2024, with basic profit per share increasing to $21.08 from $13.92 [20][19] Product Development and Pipeline - VYVGART, the company's leading product, is approved for three indications, including generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) [6][24] - Positive results from the Phase 3 ADAPT OCULUS study support the planned submission for expanding VYVGART's label into ocular myasthenia gravis (oMG) [3][6] - The company aims to treat 50,000 patients globally and secure 10 labeled indications across approved medicines by 2030 [5] Strategic Initiatives - Company is focused on expanding its FcRn portfolio and advancing multiple label expansions, including ongoing registrational studies in rheumatology [4][6] - The expected launch of the VYVGART SC autoinjector in 2027 and the progression of two next-generation FcRn candidates in 2026 are part of the growth strategy [12][26] - The company plans to have four Phase 3 molecules and a total of 10 molecules in clinical development by the end of 2026 [9][26] Market Impact - VYVGART has reached 19,000 patients globally, reinforcing the company's leadership in the myasthenia gravis market [4] - The company is advancing its pipeline with new first-in-class candidates from its Immunology Innovation Program, supporting long-term growth [4][9]