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Reported Saturday, argenx Plans To Submit Supplemental BLA For Efgartigimod In IMNM By End Of 2026 After Phase 3 ALKIVIA Shows 14.8-Point Greater TIS Improvement Versus Placebo At Week 52

Benzinga Newsdesk 7 hours ago

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ALKIVIA met its primary and key secondary endpoints in the combined IMNM and DM populationFirst Phase 3 study to demonstrate statistically significant and clinically meaningful benefit in IMNM, an autoimmune myositis

  • ALKIVIA met its primary and key secondary endpoints in the combined IMNM and DM population
  • First Phase 3 study to demonstrate statistically significant and clinically meaningful benefit in IMNM, an autoimmune myositis subtype with no approved therapies
  • Consistent, clinically meaningful treatment effect in DM, demonstrating improvements in muscle strength and skin disease activity

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