argenx
NEWS
In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA’s decisions in 2024.
The company’s FcRn inhibitor Vyvgart grew 17% quarter-over-quarter, reigniting confidence it will hit its ambitious goals despite a string of clinical setbacks in recent months.
The Roivant spinout is shifting its attention away from batoclimab to anti-FcRn candidate IMVT-1402, which will target autoimmune disorders, while allowing argenx’s Myasthenia Gravis drug Vyvgart to maintain its lead position for now.
Argenx’s subcutaneous Fc receptor blocker efgartigimod was unable to induce a significantly higher rate of complete remission than placebo in the skin autoimmune disease. The company’s stock plummeted in response to the news.
The Dutch biotech’s stock dropped about 10% Tuesday morning after the company reported that its injectable Vyvgart Hytrulo missed the primary and secondary endpoints in an immune thrombocytopenia study.
The Federal Trade Commission released new draft guidelines for assessing mergers, while an Alzheimer’s conference yielded promising data and J&J kicked off Q2 earnings season with a sound beat.
The Netherlands-based immunology company said Wednesday it brought in $1.1 billion by selling more than two million shares in the U.S. and Europe.
Argenx’s Vyvgart will now be available in the U.S. as a more convenient subcutaneous formulation 18 months after its first approval.
The FDA has four target action dates this week, including ones for Argenx’s subcutaneous efgartigimod in generalized myasthenia gravis and Sarepta’s gene therapy for Duchenne muscular dystrophy.
IN THE PRESS