Core Insights - argenx SE reported global net product sales of $398 million in the first quarter of 2024, a significant increase from $218 million in the same period of 2023, reflecting strong growth driven by the VYVGART product line [5][10][12] - The company is preparing for regulatory submissions and trials for its products, including a Supplemental Biologics License Application (sBLA) for CIDP with a PDUFA target action date of June 21, 2024, and a filing for a pre-filled syringe expected in the second quarter of 2024 [5][6][12] - argenx is advancing its pipeline with multiple programs, including registrational trials for efgartigimod in various autoimmune diseases, and aims to solidify its leadership in FcRn biology with expectations of approvals in at least 15 indications by 2025 [6][7][8] Financial Performance - Total operating income for Q1 2024 was $413 million, up from $230 million in Q1 2023, driven by product net sales and collaboration revenue [12][13] - Research and development expenses increased to $225 million in Q1 2024 from $166 million in Q1 2023, reflecting ongoing clinical development efforts [13][14] - The net loss for the period was $62 million, compared to a loss of $29 million in the same period last year, with a basic and diluted loss per share of $1.04 [15][16] Product Development and Regulatory Updates - VYVGART is now approved in over 30 countries for generalized myasthenia gravis (gMG) and has received approval in Japan for primary immune thrombocytopenia (ITP) [4][5] - The company is actively pursuing regulatory approvals for VYVGART and VYVGART SC in additional markets, including Switzerland, Australia, and China [5][6] - argenx is also advancing its pipeline with ongoing studies for efgartigimod in various conditions, including Sjogren's disease and thyroid eye disease, with data readouts expected throughout 2024 [7][8][9] Strategic Initiatives - The company continues to invest in its Immunology Innovation Program (IIP) to drive long-term pipeline growth, with four new pipeline candidates expected to be filed by the end of 2025 [8][20] - argenx has appointed Dr. Brian L. Kotzin as a non-executive director to enhance its research and development capabilities [9] - The company anticipates combined R&D and SG&A expenses to be less than $2 billion in 2024, with a net cash utilization of up to $500 million for operating expenses and capital expenditures [16]

May 7, 2024 – 5:30pm ET Amsterdam, the Netherlands – argenx SE ((Euronext &amp, NASDAQ:ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced the results of its Annual General Meeting of shareholders held today. All items on the agenda received a majority of votes in favor except for agenda item 5 (adoption of the remuneration policy). As part of the approved resolutions: The Company's annual report and annual accounts for the fina ...

Vesnaandjic/E+ via Getty Images Argenx Performance and Prospects Amid Market Challenges Argenx's (NASDAQ:ARGX) stock is down 22% since my last evaluation in October. Back then, I noted growing revenue opportunities for the company's lead asset, Vyvgart. argenx, a biotechnology developer based in Amsterdam, is a leader in the anti-FcRn market, which is expected to grow to over $10 billion. Last quarter (Q4), argenx reported $374 million in global net product revenues (Vyvgart and Vyvgart Hytrulo) and $41 ...

May 7, 2024Amsterdam, the Netherlands – argenx ((Euronext &amp, NASDAQ:ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that members of the management team will participate in a fireside chat at the BofA Securities 2024 Health Care Conference on Tuesday, May 14, 2024 at 10:00 AM PT in Las Vegas, NV. A live webcast of the fireside chat may be accessed on the Investors section of the argenx website at argenx.com/investors ...

May 7, 2024Amsterdam, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that members of the management team will participate in a fireside chat at the BofA Securities 2024 Health Care Conference on Tuesday, May 14, 2024 at 10:00 AM PT in Las Vegas, NV. A live webcast of the fireside chat may be accessed on the Investors section of the argenx website at argenx.com/investors. A ...

May 2, 2024Amsterdam, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that it will host a conference call and audio webcast on Thursday, May 9, 2024 at 2:30 PM CET (8:30 AM ET) to discuss its first quarter 2024 financial results and provide a business update. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A ...

May 2, 2024 Amsterdam, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that it will host a conference call and audio webcast on Thursday, May 9, 2024 at 2:30 PM CET (8:30 AM ET) to discuss its first quarter 2024 financial results and provide a business update. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A ...

GSK plc. (GSK) will report first-quarter 2024 results on May 1, before the opening bell. In the last reported quarter, the company reported a negative earnings surprise of 5.26%.Factors to NoteGSK reports financial figures under three segments — Specialty Medicines, Vaccines and General Medicines. Our model estimate for the company’s total revenues is pegged at £7.36 billion ($9.12 billion).In the first quarter, higher sales of newer products like Arexvy, Cabenuva, Juluca, Dovato, Trelegy Ellipta and Shingr ...

ADHERE data show VYVGART® Hytrulo has potential to be first advancement for CIDP patients in 30 years Real-world data demonstrate gMG patients able to significantly reduce steroid use over first six months of initiating VYVGART® treatment April 16, 2024 – 7:00am CET Amsterdam, the Netherlands – argenx SE ((Euronext &amp, NASDAQ:ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that data from its Phase 3 ADHERE trial eval ...

Core Viewpoint - Argenx's shares increased by 11.2% following disappointing results from Chugai Pharmaceutical's late-stage study of Enspryng for generalized myasthenia gravis (gMG), which fell short of expectations despite showing some statistical improvements [1] Group 1: Argenx's Product and Market Position - Argenx markets Vyvgart (efgartigimod), which was approved by the FDA in December 2021 for treating adults with gMG who test positive for the anti-acetylcholine receptor (AChR) antibody [2] - The company recorded $1.19 billion in product sales in 2023, a significant increase from $400.7 million in 2022, indicating strong market performance [3] - Year to date, Argenx's shares have gained 4.3%, outperforming the industry, which has seen a 1.6% decline [3] Group 2: Competitive Landscape and Future Prospects - The failure of Chugai/Roche's Enspryng in the gMG indication is expected to relieve competitive pressure on Argenx and reinforce its market leadership [3] - Argenx is also exploring Vyvgart in various clinical studies for conditions such as thyroid eye disease (TED), lupus nephropathy (LN), and myositis, with a regulatory filing for chronic inflammatory demyelinating polyneuropathy (CIDP) under review by the FDA [3] - Detailed results from the LUMINESCE study are anticipated to be presented at the American Academy of Neurology (AAN) 2024 Annual Meeting on April 15 [1] Group 3: Impact on Other Companies - Immunovant's shares rose by 4.8% following the disappointing results of Enspryng, as it is also developing batoclimab for myasthenia gravis and TED indications [4]