Regeneron Gets FDA, EMA Review of Cemdisiran in Generalized Myasthenia Gravis

Dow Jones06-22

By Colin Kellaher

Regeneron Pharmaceuticals said U.S. and European regulators have accepted its applications seeking approval of its cemdisiran drug candidate in the rare and chronic autoimmune disease generalized myasthenia gravis, or gMG.

Regeneron on Monday said the U.S. Food and Drug Administration and the European Medicines Agency will review cemdisiran to for adults with gMG who are anti-acetylcholine receptor antibody-positive.

The Tarrytown, N.Y., biotechnology company said the FDA has granted the application priority review, which shortens the review period, and that it set a target action date in November.

Regeneron, which is developing cemdisiran under a licensing agreement with Alnylam Pharmaceuticals, said it expects a decision from the European Commission in the second half of 2027.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

June 22, 2026 07:33 ET (11:33 GMT)

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