Amgen Inc. (AMGN) is awaiting a regulatory ruling on a potential third indication for UPLIZNA in generalized myasthenia gravis, with the FDA decision expected on December 14, 2025.Generalized myasthenia gravis (gMG) is a rare, chronic, B-cell-mediated autoimmune disorder that impairs neuromuscular communication and can cause muscle weakness, trouble breathing, difficulty swallowing and impaired speech and vision. Around 85% of individuals with myasthenia gravis have the generalized type, and an estimated 80,000–100,000 people in the U.S. are affected by myasthenia gravis in the U.S.In clinical trials, UPLIZNA provided sustained symptom relief for generalised myasthenia gravis with just two doses per year.There are a number of FDA-approved treatments for myasthenia gravis, like Soliris and Ultomiris, both developed by Alexion Pharmaceuticals, now part of AstraZeneca; Zilbrysq and Rystiggo from UCB; Vyvgart and Vyvgart Hytrulo, developed by Argenx; and Imaavy, developed by Johnson & Johnson, to name a few. Uplizna received FDA approval for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) in June 2020, and for the treatment of immunoglobulin G4-related disease this April.AMGN closed Wednesday’s (November 26, 2025) trading at $344.57, up 1.01%.