Cemdisiran (C5 siRNA), NIMBLE
Generalised myasthenia gravis
Sponsor: Regeneron
- 288Enrollment target
- 75Trial sites
- 5Countries
- November 2026Est. completion
- NCT05070858Registry record
About this trial
Quarterly subcutaneous siRNA targeting complement C5. The asset that advanced is cemdisiran as monotherapy, not the pozelimab combination this row previously tracked.
Primary endpoints
- MG-ADL score improvement
- Complete stable remission rate
Latest update
Regeneron's second-quarter filing confirms the New Drug Application for cemdisiran in generalised myasthenia gravis remains under FDA review with a decision guided for November 2026, following Phase 3 NIMBLE data presented at the American Academy of Neurology meeting in April 2026. A European decision is guided for the second half of 2027. The asset that advanced is cemdisiran monotherapy, not the pozelimab combination this row previously tracked.
SourceTrial information is compiled from public sources and may be out of date. It is not medical advice and is not an offer of enrolment; check the registry entry or speak to a physician before acting on it.