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Biogen to Share New SMA Data at Muscular Dystrophy Association and SMA Europe Conferences
Globenewswire· 2026-03-05 12:30
Core Insights - Biogen is set to present new data on spinal muscular atrophy (SMA) research programs, including high dose nusinersen and salanersen, at two upcoming conferences in March 2026 [1][2] SMA Research Programs - The company is at a critical point in its SMA portfolio, aiming to introduce a high dose regimen of nusinersen and advance salanersen into registrational studies [2] - Long-term data from the DEVOTE and ONWARD studies indicate benefits of high dose nusinersen for SMA patients [6] - Salanersen is entering Phase 3 studies, showcasing its potential for high potency with once-yearly dosing [6] Clinical Studies - DEVOTE is a Phase 2/3 study assessing the efficacy, safety, and tolerability of high dose nusinersen, while ONWARD serves as a long-term extension for previous participants [5] - The high dose regimen of nusinersen, known as SPINRAZA, is approved in Japan, the EU, and Switzerland, with FDA review expected by April 3, 2026 [5] - The SOLAR study is a Phase 3 trial evaluating salanersen's efficacy and safety in participants aged 15-60 years with SMA [7] Regulatory and Commercialization Efforts - Biogen is collaborating with regulatory authorities globally to progress the additional dosing option for SMA patients [5] - The company has licensed global development, manufacturing, and commercialization rights for salanersen from Ionis Pharmaceuticals [8]