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Argenx's Drug Scores European Approval For Muscular Fatigue Disorder

·1 min read
  • The European Commission has approved Argenx SE's (NASDAQ: 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 (NASDAQ: 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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