# Cemdisiran Regulatory Submissions Accepted for Review by FDA and EMA for the Treatment of Generalized Myasthenia Gravis (gMG)
Canonical URL: https://biopharmsignal.com/news/REGN/cemdisiran-regulatory-submissions-accepted-for-review-by-fda-and-ema-for-the-treatment-of-generalized-myasthenia-gravis-gmg
Ticker: REGN
Company: Regeneron Pharmaceuticals
Source: Regeneron Pharmaceuticals
Published: 2026-06-25 13:46 EST
Original Source URL: https://investor.regeneron.com
## Summary

Cemdisiran could be the first siRNA approved for the treatment of gMG and only therapy to be offered subcutaneously with four times a year dosing FDA accepted NDA under Priority Review with a target action date in November 2026; European Commission decision anticipated in the second half of 2027

## Article Body
Cemdisiran could be the first siRNA approved for the treatment of gMG and only therapy to be offered subcutaneously with four times a year dosing FDA accepted NDA under Priority Review with a target action date in November 2026; European Commission decision anticipated in the second half of 2027
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