The news

The FDA has approved a higher-dose nusinersen (Spinraza) regimen for SMA, shortening the time-to-maintenance-dose and potentially increasing CSF exposure in treatment-experienced patients. Source: SMA News Today 2026.

Why it matters

This removes one of the practical barriers to combination trials:

• High-dose Spinraza + apitegromab (SAPPHIRE already positive on standard dose)
• High-dose Spinraza + ARGX-119 (NMJ axis adjunct)
• High-dose Spinraza + omaveloxolone / CDDO-Me (NRF2 redox adjunct)

It also positions salanersen (BIIB115) more sharply as a differentiation play: if nusinersen can be dosed higher, salanersen needs to prove superiority on exposure, dosing interval, and tolerability.

In-platform: /drugs nusinersen entry updated. Linked to the 3-mechanism combo memo.