argenx SE American Depositary Shares - ARGX STOCK NEWS

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.

On November 17, 2020, argenx (ARGX) launched a docuseries titled A Mystery to Me, focusing on Myasthenia Gravis (MG), a rare autoimmune disease. The series aims to raise awareness of MG by showcasing the lives of three individuals affected by it. The docuseries is produced by Sarofsky Productions and will be available on MG-United.com following its debut. CEO Tim Van Hauwermeiren emphasized the importance of listening to MG patients to better understand their challenges. The MG Foundation highlighted the connection this series could foster within the community, particularly during the COVID-19 pandemic.