Novartis ianalumab first drug to reduce disease activity and patient burden in Sjögren’s disease Phase III trials

Novartis ianalumab first drug to reduce disease activity and patient burden in Sjögren’s disease Phase III trials
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  • NEPTUNUS-1 and NEPTUNUS-2 achieved primary objective of reduced disease activity and provided clinically meaningful benefit1 
  • Data showed consistent improvements across secondary outcome measures, and a favorable safety profile1 
  • Novartis plans to submit to health authorities globally in early 2026
  • If approved, ianalumab could become first targeted treatment for this heterogeneous, systemic autoimmune disease
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New Novartis data at ASN Kidney Week and AHA Scientific Sessions demonstrate momentum of broad CRM portfolio and pipeline

New Novartis data at ASN Kidney Week and AHA Scientific Sessions demonstrate momentum of broad CRM portfolio and pipeline
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  • Fabhalta and Vanrafia Phase III analyses, Fabhalta real-world treatment pattern data, and zigakibart Phase I/II trial showcase strength of IgA nephropathy (IgAN) portfolio
  • C3 glomerulopathy (C3G) studies add to body of evidence of Fabhalta long-term safety and efficacy profile in native and post-transplant disease recurrence patients
  • V-INCEPTION analyses highlight Leqvio adherence and goal attainment data when initiated early in post-acute coronary syndrome patients
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Novartis opens new radioligand therapy manufacturing facility in California as part of $23B US expansion plan

Novartis opens new radioligand therapy manufacturing facility in California as part of $23B US expansion plan
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  • Carlsbad location is company’s third US-based radioligand therapy (RLT) manufacturing site
  • New site expands manufacturing footprint to meet future demand; ensures continued on-time delivery rate of >99.9% to patients across western US, Alaska and Hawaii
  • First to have delivered at scale, Novartis fortifies leadership in RLT innovation and infrastructure with California facility, additional plans for Florida and Texas
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Novartis Phase III trial for next-generation malaria treatment KLU156 (GanLum) meets primary endpoint, with potential to combat antimalarial resistance

Novartis Phase III trial for next-generation malaria treatment KLU156 (GanLum) meets primary endpoint, with potential to combat antimalarial resistance
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  • Phase III trial for KLU156 (ganaplacide/lumefantrine, or GanLum), meets primary endpoint of non-inferiority to standard of care Coartem® (artemether-lumefantrine)
  • Demonstrates PCR-corrected cure rate of 97.4% based on estimand method, equating to 99.2% under conventional per protocol analysis
  • If approved, GanLum would represent first major innovation in malaria treatment since 1999, with potential to kill drug-resistant parasites and block transmission
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