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
arcticnovartis

Ad hoc announcement pursuant to Art. 53 LR

First quarter

/by

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 
arcticnovartis

  • 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
/by

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 
arcticnovartis

  • 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
/by

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 
arcticnovartis

  • 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
/by

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 
arcticnovartis

  • 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
/by

Novartis receives positive CHMP opinion for Itvisma® for spinal muscular atrophy (SMA)

Novartis receives positive CHMP opinion for Itvisma® for spinal muscular atrophy (SMA)
arcticnovartis

  • 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
/by

Novartis receives positive CHMP opinion for Itvisma® for spinal muscular atrophy (SMA)

Novartis receives positive CHMP opinion for Itvisma® for spinal muscular atrophy (SMA)
arcticnovartis

  • 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
/by

Novartis receives positive CHMP opinion for Itvisma® for spinal muscular atrophy (SMA)

Novartis receives positive CHMP opinion for Itvisma® for spinal muscular atrophy (SMA)
arcticnovartis

  • 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
/by

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
arcticnovartis

  • 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
/by

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
arcticnovartis

  • 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
/by