- The European Commission has approved Argenx SE's ARGX Vyvgart (efgartigimod alfa-fcab) as an add-on to standard therapy for generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody positive.
- gMG is characterized by weakness and rapid fatigue of any of the muscles under voluntary control. It's caused by a breakdown in the regular communication between nerves and muscles.
- Related: Argenx's Vyvgart To 'Achieve Blockbuster Status,' This Analyst Says With 6% Price Target Hike.
- Argenx's plans remain on track to launch Vyvgart in Canada and China through its collaboration with Zai Lab Limited ZLAB and in select additional regions.
- The approval is based on results from the Phase 3 ADAPT trial demonstrating that 68% of the patients were responders on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale following treatment with efgartigimod compared to 30% on placebo.
- Price Action: ARGX shares are up 1.29% at $379.08 on the last check Thursday.
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