Regeneron’s rare immune disorder therapy meets main goal of late-stage trial

(Reuters) -Regeneron Pharmaceuticals said on Tuesday its experimental therapy for treating patients with a rare immune disorder has met the main goal of a late-stage study.

The therapy, cemdisiran, helped reduce the severity of generalized myasthenia gravis in adults and improve functional activities, when compared to placebo, the drugmaker said.

Generalized myasthenia gravis is caused by an abnormal immune reaction in which the body mistakenly attacks itself, weakening the skeletal muscles, especially those controlling the eyes, mouth, throat and limbs, leading to fatigue, difficulty swallowing and breathing.

The company plans to submit a marketing application for the therapy to the U.S. Food and Drug Administration in the first quarter of 2026.

(Reporting by Siddhi Mahatole in Bengaluru; Editing by Shilpi Majumdar)