Biogen will present new spinal muscular atrophy (SMA) data at the 2026 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference (March 8‑11) and the 5th International Scientific Congress on SMA (SMA Europe 2026; March 11‑14). The company will showcase results from the DEVOTE Phase 2/3 trial of high‑dose nusinersen, the ONWARD Phase 3 long‑term extension for DEVOTE participants, and the design of salanersen’s Phase 3 studies.
High‑dose nusinersen, approved in the EU, Japan, and Switzerland, is under U.S. FDA review with a decision expected on April 3 2026. The DEVOTE study demonstrated a faster reduction in neurofilament biomarkers and improved motor function, supporting the high‑dose regimen’s potential clinical benefit.
Salanersen, licensed from Ionis Pharmaceuticals, is an investigational antisense oligonucleotide designed for once‑yearly dosing and greater potency. Biogen is advancing it into Phase 3, aiming to broaden its SMA portfolio beyond the current low‑dose SPINRAZA regimen.
The presentation follows Biogen’s strong Q4 2025 results, with non‑GAAP diluted EPS of $1.99 and full‑year 2025 EPS of $15.28, underscoring the company’s financial strength to fund R&D.
Biogen’s strategy to expand its SMA pipeline positions it against competitors Roche’s Evrysdi and Novartis’ Zolgensma. The upcoming FDA decision and conference data are expected to reinforce Biogen’s leadership and support future regulatory submissions.
"We are at an important juncture for our SMA portfolio as we look to bring the high dose regimen of nusinersen to the community and advance salanersen into registrational studies," said Stephanie Fradette, Head of the Neuromuscular Development Unit at Biogen.
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