Biogen to Present New SMA Data at Key Conferences
Event summary
- Biogen will present new data on high-dose nusinersen and salanersen at the 2026 MDA Clinical & Scientific Conference and SMA Europe Congress.
- Long-term data from DEVOTE/ONWARD studies show benefits of high-dose nusinersen in SMA patients.
- Phase 1b data on salanersen illustrate potential for high potency with once-yearly dosing.
- FDA decision on high-dose nusinersen expected by April 3, 2026.
The big picture
Biogen's presentation of new SMA data comes at a critical juncture for its neuromuscular portfolio. The company is positioning itself to expand the use of high-dose nusinersen while advancing salanersen, a potential high-potency treatment with once-yearly dosing. The strategic focus on SMA reflects Biogen's commitment to addressing unmet needs in the neuromuscular space, though it faces regulatory and competitive challenges.
What we're watching
- Regulatory Approval
- Whether the FDA will approve the high-dose regimen of nusinersen by the April 3, 2026 deadline.
- Clinical Efficacy
- How the long-term data from DEVOTE/ONWARD studies will impact the adoption of high-dose nusinersen.
- Market Competition
- The pace at which Biogen can advance salanersen into registrational studies amid existing SMA treatments.
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