Biogen Presents Long-Term High-Dose SPINRAZA Data, Kicks Off Salanersen Phase 3 Trials
Long-term data from Biogen’s DEVOTE/ONWARD studies demonstrate clinical benefits of 50 mg high-dose nusinersen in patients with spinal muscular atrophy and support an FDA decision expected April 3, 2026. Biogen also unveiled Phase 3 trial initiations for salanersen and upcoming presentations at March 8–14 MDA and SMA Europe conferences.
1. DEVOTE/ONWARD Long-Term Data
Biogen reported integrated results from its Phase 2/3 DEVOTE and long-term ONWARD extension showing that a 50 mg high-dose regimen of nusinersen (SPINRAZA) improved motor function and was well-tolerated in spinal muscular atrophy patients. These findings bolster the company’s supplemental application, with an FDA verdict due April 3, 2026, and expand dosing options beyond the 12 mg regimen approved in over 71 countries.
2. Salanersen Phase 3 Initiations
Biogen has launched its STELLAR and SOLAR Phase 3 registrational trials to evaluate salanersen’s efficacy and safety in infants and participants aged 15–60 with spinal muscular atrophy. This program follows promising Phase 1b results, positioning salanersen as a once-yearly high-potency investigational therapy.
3. Upcoming Conference Presentations
New data will be showcased at the 2026 Muscular Dystrophy Association Clinical & Scientific Conference (March 8–11) and the 5th International Scientific Congress on SMA Europe (March 11–14). Biogen’s agenda includes higher-dose nusinersen posters, salanersen trial designs and Phase 1 interim findings, plus neurofilament biomarker analyses.