USFDAJun 22, 2026, 07:02 AM
Regeneron's Cemdisiran for gMG Accepted for FDA Priority Review
AI Summary
Regeneron announced that the FDA and EMA have accepted regulatory applications for cemdisiran to treat adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. The FDA granted Priority Review with a target action date in November 2026, utilizing a Priority Review Voucher. A decision from the European Commission is expected in the second half of 2027, with a Japanese filing planned for early 2027.
Key Highlights
- FDA accepted NDA for cemdisiran under Priority Review for gMG.
- Target action date for FDA decision is November 2026.
- European Commission decision anticipated in the second half of 2027.
- Cemdisiran is proposed as a subcutaneous treatment with four times a year dosing.
- Submissions are supported by data from the Phase 3 NIMBLE trial.
- A regulatory filing in Japan is planned for early 2027.
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