Biogen announced that the European Commission has updated SPINRAZA’s marketing authorization to include a high-dose regimen for 5q spinal muscular atrophy, the form accounting for roughly 95% of cases. Supported by data from the Phase 2/3 DEVOTE study, the regimen features two 50 mg loading doses administered 14 days apart followed by 28 mg maintenance doses every four months. Treatment-naïve infants on this regimen achieved a mean 26.19-point improvement on the CHOP-INTEND motor function scale at six months (p < 0.0001 versus a matched sham control), and previously treated patients transitioning from the 12 mg dose saw a mean 1.8-point gain on the Hammersmith Functional Motor Scale–Expanded over 302 days. Safety findings mirrored the known profile of nusinersen, with no new concerns emerging in the long-term extension.

In the latest SEC filings, Cerity Partners LLC raised its stake in Biogen by 76.7%, acquiring an additional 35,696 shares to reach 82,248 shares valued at approximately $11.5 million. Other institutions, including Banque Pictet & Cie SA and Generali Investments CEE, also increased their holdings, while hedge funds collectively control 87.93% of the outstanding shares. On the research front, 10 analysts maintain Buy ratings, 15 recommend Hold and 1 suggests Sell, yielding a consensus Hold. Wall Street models project full-year 2025 earnings of $14.50 to $15.00 per share, with consensus forecasts pointing to $15.83, reflecting confidence in Biogen’s pipeline advancement and commercial execution.