Cemdisiran
Generalized myasthenia gravis · Adults with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis
REGN · Regeneron Pharmaceuticals
Regulatory designations
Full timeline
4 milestonesFDA decision expected
FDA assigned a November 2026 target action date to the cemdisiran NDA submitted under Priority Review; the company has not disclosed a more specific day.
Regeneron — Cemdisiran NDA acceptance and PDUFA timing↗FDA accepted the NDA with Priority Review
FDA accepted the cemdisiran NDA for adults with anti-AChR antibody-positive generalized myasthenia gravis under Priority Review after use of a Priority Review Voucher.
Regeneron — Cemdisiran NDA acceptance↗NIMBLE Phase 3 results were reported
Cemdisiran monotherapy met the primary and key secondary endpoints in NIMBLE. The trial also evaluated cemdisiran plus pozelimab, but the filed U.S. NDA is for cemdisiran monotherapy.
Regeneron — Positive NIMBLE Phase 3 results↗NIMBLE Phase 3 study started
NIMBLE began evaluating cemdisiran monotherapy and the cemdisiran-pozelimab combination in adults with symptomatic generalized myasthenia gravis.
ClinicalTrials.gov — NIMBLE study record (NCT05070858)↗Related News
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