Also known as Lunsumio.
Interim analysis shows a significant progression‑free survival benefit versus rituximab+lenalidomide in second‑line or later relapsed/refractory follicular lymphoma; safety as expected.
Phase III CELESTIMO interim analysis showed a statistically significant, clinically meaningful PFS benefit versus rituximab+lenalidomide; OS immature; safety consistent with known profiles.
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.
sBLA accepted based on phase III SUNMO showing 59% reduction in progression risk; FDA decision expected by 9 Feb 2027.
Core rev ¥321.7B (+11.5%), core OP ¥163.3B (+17.1%), core net ¥118.6B (+19.6%). Launched Elevidys (DMD JP); Lunsumio+Polivy approved for LBCL. R&D: NXT007 switch, Enspryng (MOGAD), Foundayo US approval.
Japan approves Lunsumio + Polivy for relapsed/refractory large B‑cell lymphoma after Phase III SUNMO: ORR 69.7%, PFS 11.5 vs 3.8 months (59% lower progression/death risk); manageable safety.
Pharmaceuticals and diagnostics drive profit and earnings growth. Key approvals and advancements in therapies. Dividend increase proposed. Board changes announced. Positive 2026 outlook.
Lunsumio VELO cuts treatment time to one minute for relapsed follicular lymphoma, offering outpatient care with a manageable safety profile.
Lunsumio SC offers quick administration for relapsed follicular lymphoma, reducing treatment time to one minute with proven efficacy and safety.
