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Regeneron says Phase 3 NIMBLE trial met endpoints for cemdisiran in generalized myasthenia gravis

Apr 21, 2026

Regeneron said the Phase 3 NIMBLE trial of cemdisiran in generalized myasthenia gravis met primary and key secondary endpoints at week 24. The company said a U.S. regulatory application has been submitted and EU filings are planned for 2026.

Amgen's Uplizna Wins FDA and European Approval for Generalized Myasthenia Gravis

Dec 11, 2025

Amgen received FDA and European Commission approval for Uplizna to treat generalized myasthenia gravis in adults who are anti-AChR or anti-MuSK antibody positive, offering twice-yearly maintenance dosing after initial loading doses.