Regeneron says FDA accepts cemdisiran gMG filing for priority review

Regeneron’s FDA application for cemdisiran in anti-AChR antibody-positive generalized myasthenia gravis was accepted under Priority Review. * FDA target action date set for November 2026, supported by a Priority Review Voucher. * EMA also validated the filing; a European Commission decision is expected in the second half of 2027. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Regeneron Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202606220700PRIMZONEFULLFEED9750141) on June 22, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)

Regeneron announced that the FDA has accepted its filing for cemdisiran to treat anti-AChR antibody-positive generalized myasthenia gravis (gMG) under Priority Review. The target action date is set for November 2026, supported by a Priority Review Voucher. Additionally, the EMA validated the filing, with a European Commission decision expected in the second half of 2027.

Regeneron’s FDA application for cemdisiran in anti-AChR antibody-positive generalized myasthenia gravis was accepted under Priority Review. * FDA target action date set for November 2026, supported by a Priority Review Voucher. * EMA also validated the filing; a European Commission decision is expected in the second half of 2027. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Regeneron Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202606220700PRIMZONEFULLFEED9750141) on June 22, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)