RARE Daily

Argenx raises $700 million in gross proceeds in a global offering; Reports Positive Phase 3 MG Results

March 25, 2022

Argenx, a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, raised $700 million in a secondary offering, the largest financing year-to-date for a rare disease drug developer.

Photo: Tim Van Hauwermeiren, CEO of Argenx

The financing came as the company reported positive phase 3 topline results for its experimental therapy efgartigimod to treat the rare, autoimmune condition generalized myasthenia gravis.

The global offering consisted of ordinary shares represented by American Depository Shares in the United States and certain other countries outside of the European Economic Area and a simultaneous private placement of ordinary shares in the European Economic Area and the United Kingdom.

The company expects total gross proceeds of approximately $700 million (approximately €637 million) from the sale of 1,551,044 ADSs at a price of $300.00 per ADS and the sale of 782,290 ordinary shares at a price of €273.10 per ordinary share. The U.S. offering and the European private placement are currently expected to close simultaneously on March 28, 2022, subject to customary closing conditions.

Argenx has also granted the underwriters of the offering a 30-day option to purchase up to 350,000 ordinary shares (which may be represented by ADSs) on the same terms and conditions.

Argenx’s ADSs are currently listed on the Nasdaq Global Select Market under the symbol “ARGX” and Argenx’s ordinary shares are currently listed on Euronext Brussels under the symbol “ARGX.”

Separately, the company said its phase 3 ADAPT-SC study evaluating subcutaneous efgartigimod for generalized myasthenia gravis met its primary endpoint, demonstrating noninferiority to Vyvgart (efgartigimod alfa-fcab) intravenous (IV) formulation as measured by total IgG reduction at day 29. The company won U.S. Food and Drug Administration approval for Vyvgart at the end of 2021. Secondary endpoints show clinical improvement consistent with IV administration.

Generalized myasthenia gravis (gMG) is a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness. Approximately 85 percent of people with MG progress to gMG within 24 months, where muscles throughout the body may be affected. Patients with confirmed anti-acetylcholine receptor (AChR) antibodies account for approximately 85 percent of the total gMG population.

SC efgartigimod is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology. ENHANZE facilitates subcutaneous injection delivery of biologics that are typically administered via infusion, providing additional treatment options to patients based on individual preferences.

The company said it is on track to be submit an application to the FDA by end of 2022 to seek marketing approval.

“Every person living with gMG experiences the disease in their own way, including how they manage symptoms,” said James Howard Jr., professor of Neurology, Medicine and Allied Health, Department of Neurology, The University of North Carolina at Chapel Hill School of Medicine, and principal investigator for the ADAPT-SC trial. “For many years, patients lacked sufficient treatment options, let alone those that were tailored to their unique needs. These data, along with the recent approval of the intravenous formulation, VYVGART, represent exciting advancements in the management of this debilitating, unpredictable disease by offering patients and physicians the option to select treatment based on individual needs and preferences.”

“Our goal is to redefine and deliver targeted treatment options for people living with gMG globally. By listening to the gMG community, we heard the importance of creating optionality and flexibility for patients,” said Tim Van Hauwermeiren, CEO of Argenx. “The ADAPT-SC results mark another important step toward achieving this, and further support our vision of delivering a broad array of treatment options for gMG.”

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