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Regeneron Says Cemdisiran Monotherapy Meets Primary, Key Secondary Endpoints in Late-Stage Trial in Generalized Myasthenia Gravis Patients
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Regeneron Says Cemdisiran Monotherapy Meets Primary, Key Secondary Endpoints in Late-Stage Trial in Generalized Myasthenia Gravis Patients
Aug 26, 2025 5:20 AM

07:54 AM EDT, 08/26/2025 (MT Newswires) -- Regeneron Pharmaceuticals ( REGN ) said Tuesday that its investigational cemdisiran monotherapy met the primary and key secondary endpoints in a late-stage trial in adults with generalized myasthenia gravis.

The company said Cemdisiran monotherapy showed a 2.3-point placebo-adjusted improvement in MG-ADL total score.

Detailed results from the trial will be presented at an upcoming medical meeting, the company said.

Regeneron said it plans a US regulatory application for cemdisiran in Q1 of next year, pending discussions with the US Food and Drug Administration.

Shares of Regeneron were up 0.5% in recent Tuesday premarket activity.

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