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Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy and Cemdisiran Monotherapy in Patients with Symptomatic Generalized Myasthenia Gravis

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Trial Profile

Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy and Cemdisiran Monotherapy in Patients with Symptomatic Generalized Myasthenia Gravis

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 10 Jul 2026

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At a glance

  • Drugs Cemdisiran (Primary) ; Pozelimab (Primary)
  • Indications Myasthenia gravis
  • Focus Registrational; Therapeutic Use
  • Acronyms NIMBLE
  • Sponsors Regeneron Pharmaceuticals

Most Recent Events

  • 22 Jun 2026 According to Regeneron Pharmaceuticals media release, a decision from the European Commission is anticipated in the second half of 2027. A regulatory filing in Japan is also planned for early 2027.
  • 22 Jun 2026 According to Regeneron Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted the regulatory applications for cemdisiran to treat adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. The FDA will review the New Drug Application (NDA) under Priority Review with a target action date in November 2026, following use of a Priority Review Voucher.
  • 21 Apr 2026 Results published in the Media Release

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