Welcome to our dedicated page for Argenx Se news (Ticker: ARGX), a resource for investors and traders seeking the latest updates and insights on Argenx Se stock.
argenx SE (ARGX) is a global immunology company listed on Euronext and Nasdaq that focuses on severe autoimmune diseases through antibody-based medicines. Its news flow centers on clinical data, regulatory milestones, commercial performance and strategic updates related to its FcRn-targeting medicine VYVGART and a broader pipeline of experimental antibodies.
Investors and healthcare observers following ARGX news can read about regulatory interactions such as the U.S. Food and Drug Administration’s acceptance for priority review of a supplemental Biologics License Application (sBLA) for VYVGART in acetylcholine receptor antibody seronegative generalized myasthenia gravis (gMG). Company announcements also cover Phase 3 trial readouts, including the ADAPT SERON study in seronegative gMG and other registrational programs across neuromuscular and autoimmune indications.
argenx regularly reports preliminary and quarterly financial results, highlighting global product net sales from the VYVGART franchise and outlining strategic priorities tied to its long-term "Vision 2030". News items describe the expansion of VYVGART and VYVGART Hytrulo across gMG, chronic inflammatory demyelinating polyneuropathy (CIDP) and immune thrombocytopenia (ITP) in certain regions, as well as progress with pipeline candidates such as empasiprubart and ARGX-119.
Corporate news includes leadership transitions, conference presentations at major medical and investor meetings, and updates from the company’s Immunology Innovation Program (IIP). For readers interested in ARGX stock and the evolution of its immunology franchise, this news feed provides a consolidated view of clinical, regulatory, commercial and corporate developments as disclosed in argenx press releases and related filings.
argenx (Euronext & Nasdaq: ARGX) announced management's participation in several upcoming investor conferences. Key events include the Goldman Sachs 42nd Annual Global Healthcare Conference on June 8, JMP Securities Life Sciences Conference on June 16, J.P. Morgan European Healthcare Conference on June 17, and Raymond James Human Health Innovation Conference on June 22, 2021. The company focuses on developing treatments for severe autoimmune diseases and cancer, including efgartigimod and cusatuzumab.
argenx reported strong first-quarter 2021 results with revenue soaring to $158 million, a significant increase from $21 million in Q1 2020. The company announced that the Japanese Marketing Authorization Application for efgartigimod was accepted for review, following similar FDA acceptance in the U.S. with a target decision date of December 17, 2021. The firm is advancing registrational trials across multiple indications and plans to initiate two additional indications this year. Cash and equivalents reached $2.9 billion, bolstered by a public offering that raised $1.15 billion.
On May 11, 2021, argenx SE held its Annual General Meeting of Shareholders where all proposed resolutions were passed. Key decisions included the appointment of Yvonne Greenstreet and re-appointment of Anthony Rosenberg as non-executive directors for four-year terms. The Board was authorized to issue additional shares up to 10% of share capital for 18 months. The 2020 remuneration report and new remuneration policy were approved, and Deloitte Accountants B.V. was appointed as the auditor for 2021. Dr. David Lacey resigned from the Board but will serve in an advisory role.
argenx (Euronext & Nasdaq: ARGX) will host a conference call and audio webcast on May 14, 2021, at 2:30 p.m. CET (8:30 a.m. ET) to discuss its Q1 2021 financial results and present a business update.
Investors can access the call via the Investors section of the argenx website. The company is focused on advancing innovative antibody therapies for severe autoimmune diseases and cancer.
argenx (Euronext & Nasdaq: ARGX), a global immunology company, announced management participation in two upcoming conferences. The Kempen Life Sciences Conference will include investor meetings on May 5, 2021, while a BofA Securities Virtual Healthcare Conference will feature a fireside chat on May 13, 2021, at 8:00 a.m. ET. The company focuses on developing treatments for severe autoimmune diseases and cancer, working with leading researchers through its Immunology Innovation Program.
argenx SE has announced its annual general meeting scheduled for May 11, 2021, at the Hilton Amsterdam Airport. The meeting will include discussions on the 2020 Annual Accounts, the company's remuneration report, and the discharge of directors. Shareholders are encouraged to vote by proxy due to COVID-19. Important agenda items include approval of an updated remuneration policy and the appointment of new board members. The full agenda and relevant documents are available on the argenx website.
The FDA has accepted the Biologics License Application for IV efgartigimod, targeting generalized myasthenia gravis (gMG). This marks a significant milestone for argenx as it prepares for a commercial launch, anticipated in 2021.
Financial results reveal a revenue drop to €36.4 million in 2020, down €33.4 million from 2019. Operating expenses surged, leading to a total operating loss of €417.8 million. Despite losses, cash and equivalents increased to €1.63 billion, primarily due to a successful global offering. Increased spending is expected in 2021 due to expansion initiatives.
argenx announced the FDA's acceptance of its Biologics License Application (BLA) for efgartigimod to treat generalized myasthenia gravis (gMG). If approved, efgartigimod will be the first FcRn antagonist on the market, with a target action date set for December 17, 2021. The pivotal Phase 3 ADAPT trial showed that 67.7% of treated patients met the primary endpoint, significantly outperforming placebo (29.7%). A pre-approval access program has been launched in the U.S. for eligible gMG patients. argenx plans to submit applications to the EMA and Japan's PMDA later in 2021.
argenx (Euronext & Nasdaq: ARGX) will host a conference call on March 4, 2021, at 2:30 p.m. CET to discuss its full year 2020 financial results and provide a business update for Q4. Investors can access the live webcast on the company’s website, along with a replay available for a year. argenx focuses on developing novel antibody-based therapeutics for severe autoimmune diseases and cancer, collaborating with Janssen on key treatments, including efgartigimod and cusatuzumab.
argenx SE announced the closing of its global offering of 3,593,750 ordinary shares, generating gross proceeds of approximately $1.15 billion. This includes the full exercise of underwriters' options for 468,750 ADSs. The shares will commence trading on Euronext Brussels. The offering was led by J.P. Morgan, Morgan Stanley, BofA Securities, and Cowen. This press release serves informational purposes and does not constitute an offer to sell or solicitation.