Novartis delivered strong growth in priority brands and launches in Q1; FY 2026 guidance reaffirmed

Novartis delivered strong growth in priority brands and launches in Q1; FY 2026 guidance reaffirmed
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Ad hoc announcement pursuant to Art. 53 LR

First quarter

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Novartis Rhapsido® receives European Commission approval as first oral targeted treatment for chronic spontaneous urticaria 

Novartis Rhapsido® receives European Commission approval as first oral targeted treatment for chronic spontaneous urticaria 
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  • Significant improvements as early as Week 1, favorable safety profile and no liver safety concerns in REMIX 1 & 2 studies of highly selective, oral BTKi1
  • Rhapsido recommended in 2026 International Urticaria Guideline for all patients who remain symptomatic after H1-antihistamine treatment2
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Novartis receives positive CHMP opinion for Itvisma® for spinal muscular atrophy (SMA)

Novartis receives positive CHMP opinion for Itvisma® for spinal muscular atrophy (SMA)
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  • If approved, Itvisma (intrathecal onasemnogene abeparvovec) will be first and only gene replacement therapy for children two years and older, teens and adults with SMA in the European Union
  • Itvisma demonstrated clinically meaningful and statistically significant improvement in motor function in Phase III STEER study
  • One-time dose of Itvisma replaces SMN1 gene, with potential to reduce need for chronic SMA treatment
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Novartis receives positive CHMP opinion for Itvisma® for spinal muscular atrophy (SMA)

Novartis receives positive CHMP opinion for Itvisma® for spinal muscular atrophy (SMA)
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  • If approved, Itvisma (intrathecal onasemnogene abeparvovec) will be first and only gene replacement therapy for children two years and older, teens and adults with SMA in the European Union
  • Itvisma demonstrated clinically meaningful and statistically significant improvement in motor function in Phase III STEER study
  • One-time dose of Itvisma replaces SMN1 gene, with potential to reduce need for chronic SMA treatment
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Novartis malaria treatment Coartem® Baby receives WHO prequalification, paving way for greater access for newborns and young infants

Novartis malaria treatment Coartem® Baby receives WHO prequalification, paving way for greater access for newborns and young infants
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  • Coartem® (artemether-lumefantrine) Baby is the first and only malaria treatment for newborns and young infants, closing long-standing treatment gap
  • WHO prequalification key milestone for donor-funded and public sector purchasing by UN and other procurement agencies
  • Novartis making treatment available on largely not-for-profit basis in areas where malaria is endemic
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Novartis malaria treatment Coartem® Baby receives WHO prequalification, paving way for greater access for newborns and young infants

Novartis malaria treatment Coartem® Baby receives WHO prequalification, paving way for greater access for newborns and young infants
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  • Coartem® (artemether-lumefantrine) Baby is the first and only malaria treatment for newborns and young infants, closing long-standing treatment gap
  • WHO prequalification key milestone for donor-funded and public sector purchasing by UN and other procurement agencies
  • Novartis making treatment available on largely not-for-profit basis in areas where malaria is endemic
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Novartis announces expansion of community health programs to close gaps in heart disease and cancer care, targeting more than 30 countries by 2030

Novartis announces expansion of community health programs to close gaps in heart disease and cancer care, targeting more than 30 countries by 2030
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  • Strengthens three community health models spanning community‑embedded care, earlier intervention and data‑driven population health

  • Scales program footprint from 11 countries to more than 30 by 2030, including across five cities in the U.S.

  • Builds on pilot programs that demonstrated significant increase in control rates for high blood pressure in pilot settings
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Working with communities to close gaps in heart disease and cancer care

Working with communities to close gaps in heart disease and cancer care
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Managing Quality of Life with CML

Managing Quality of Life with CML
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