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FDA and EMA accept cemdisiran for review to treat generalized myasthenia gravis with decision expected by 2027

Market News
22 Jun 2026
GlobeNewsWire
View Source
Bullish
pluang ai news

Regeneron's cemdisiran, a potential first siRNA therapy for generalized myasthenia gravis (gMG), has been accepted for regulatory review by the FDA and EMA. The FDA is conducting a Priority Review with a decision expected by November 2026, while the European Commission's decision is anticipated in the second half of 2027. Cemdisiran is administered subcutaneously every 12 weeks and targets patients with anti-AChR antibody-positive gMG, offering a novel treatment option with less frequent dosing. This follows positive Phase 3 trial results from the NIMBLE study, addressing a significant unmet need in managing this rare autoimmune disease.

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