ARGX - Why Is European Drugmaker Argenx Stock Trading Higher On Monday? | Benzinga
Friday, the FDA approved Argenx SE’s (NASDAQ:ARGX) Vyvgart Hytrulo for use in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
Vyvgart Hytrulo is approved for CIDP as a once-weekly 30-to-90-second subcutaneous injection. It is the first and only neonatal Fc receptor (FcRn) blocker approved for CIDP.
CIDP is an autoimmune disorder in which the body’s immune system attacks the myelin that insulates and protects the body’s nerves. It causes muscle weakness, numbness, and other symptoms.
The FDA approval is based on the ADHERE Study that showed that 69% (221/322) of patients treated with Vyvgart Hytrulo, regardless of prior treatment, demonstrated evidence of clinical improvement, including improvements in mobility, function, and strength.
ADHERE met its primary endpoint demonstrating ...