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), 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.
argenx SE announced the full exercise of an option by underwriters for its global offering, resulting in the sale of an additional 468,750 American Depositary Shares (ADSs). This action brings the total gross proceeds from the offering to approximately $1.15 billion (~€954.8 million), with a total of 3,593,750 ordinary shares sold. The closing of this offering is expected on February 5, 2021, subject to customary conditions. The offering is conducted under an automatically effective shelf registration with the SEC.
argenx SE announced a global offering of ordinary shares and American Depository Shares (ADSs), priced to raise approximately $1.0 billion (about €830.3 million). It involves the sale of 1,608,000 ADSs at $320.00 each and 1,517,000 ordinary shares at €265.69 each, with expected closing on February 5, 2021. The offering includes a 30-day option for underwriters to purchase an additional 468,750 shares. The securities are offered under a shelf registration statement filed with the SEC.
argenx SE announced a global offering of $750 million (approx. €618 million) of ordinary shares, represented by American Depository Shares (ADSs). This offering includes a U.S. offering and a European private placement, expected to close simultaneously. Notably, Baillie Gifford has shown interest to purchase up to $415 million (approx. €342 million) in shares. The offering allows underwriters a 30-day option to buy an additional 15% of shares. argenx's ADSs trade on Nasdaq under ARGX, while ordinary shares are listed on Euronext Brussels.
argenx announced the continuation of patient enrollment in the ADHERE trial for efgartigimod in treating chronic inflammatory demyelinating polyneuropathy (CIDP). The independent data monitoring committee confirmed this decision after interim efficacy and safety assessments surpassed predefined thresholds. The aim is to enroll approximately 130 patients to support the drug's potential registration. The company underscores the clinical proof-of-concept for efgartigimod in CIDP, enhancing its portfolio of treatments for autoimmune diseases.