TheTechno Optimist.

LeqvioNovartis—Leqvio (inclisiran) Q2 2026 revenue reaches $480M, up 59% year-over-year, with peak sales target of $4-5BItvisma (onasemnogene abeparvovec-brve)Novartis—EU approves Itvisma for SMA in children 2+ and adultsDel-zota (delpacibart zotadirsen)Novartis—FDA accepts BLA for del-zota in DMD44 with priority reviewLeqvioNovartis—FDA updates Leqvio label to recognize cardiovascular outcomes benefits

Itvisma (onasemnogene abeparvovec-brve)

by NovartisCH

Treat spinal muscular atrophy with single-dose gene replacement.

DeployStage 4 of 5

FDA approved Nov 2025; EU July 2, 2026.

Updated 2 Jul 2026Checked 11 Oct0 updates this week

Milestones

No announced next step
  1. Phase IIIb STRENGTH trial completed2025Complete.
  2. FDA approval for SMA (patients 2+)Nov 2025Complete.
  3. EU European Commission approval2 Jul 2026Complete.

Most important updates

Primer