Also known as Gazyva and Gazyvaro.
Priority Review follows MAJESTY phase III showing 36.9% complete remission at two years vs 5.7% with tacrolimus; FDA decision expected by Nov 2026.
FDA granted priority review for obinutuzumab in pMN after Phase III MAJESTY showed markedly higher complete remission vs tacrolimus; FDA decision expected Nov 2026.
Phase III INShore showed improved sustained remission and steroid reduction versus MMF; no new safety signals, supporting a regulatory application.
ALLEGORY phase III: SRI‑4 response 76.7% vs 53.5% (adj diff 23.1%), doubled remission rates, fewer flares and reduced steroid use. FDA decision expected by Dec 2026.
FDA accepted sBLA for an anti‑CD20 in SLE after Phase III ALLEGORY: SRI‑4 responders 76.7% vs 53.5%, higher remission, fewer flares and steroid reduction; decision due Dec 2026.
Gazyva shows significant improvement in SLE symptoms, achieving a 76.7% response rate and doubling remission rates in a Phase III trial, as published in NEJM.
FDA approves all-oral, fixed-duration regimen for CLL, reducing treatment time. AMPLIFY study shows 35% lower risk of progression or death compared to chemoimmunotherapy.
Phase III study shows Gazyva achieves higher remission rates in membranous nephropathy, with safety consistent and no new signals. Data to be shared with health authorities.
Phase III study shows Gazyva achieves significant remission in primary membranous nephropathy, with safety profile consistent and no new signals. Data to be shared with health authorities.
Pharmaceuticals and diagnostics drive profit and earnings growth. Key approvals and advancements in therapies. Dividend increase proposed. Board changes announced. Positive 2026 outlook.
