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

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: 25 Sep 2025

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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

  • 26 Aug 2025 According to Regeneron Pharmaceuticals media release, detailed results from the NIMBLE trial will be presented at an upcoming medical meeting.
  • 26 Aug 2025 According to Regeneron Pharmaceuticals media release, Primary endpoint has been met. (Change in Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score)
  • 26 Aug 2025 According to Regeneron Pharmaceuticals media release, U.S. regulatory submission for cemdisiran monotherapy is planned for the first quarter of 2026, pending discussions with the FDA.

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