News Related to Cemdisiran

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Regeneron Receives FDA Priority Review for Garetosmab in FOP, EMA Review for Cemdisiran in gMG

Jun 22, 2026

Regeneron announced FDA and EMA review acceptance for cemdisiran in generalized myasthenia gravis and FDA priority review acceptance for garetosmab in fibrodysplasia ossificans progressiva. The garetosmab BLA is supported by Phase 3 OPTIMA trial data showing 94% and 90% reductions in new bone lesions.

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.