FDA Approves First SMA Drug That Targets Muscle Loss, Not Just Nerves
The FDA approved Scholar Rock’s Isembyld, the first SMA therapy aimed at muscle wasting in patients already on nerve-targeted treatment.
The FDA approved Scholar Rock’s Isembyld, the first SMA therapy aimed at muscle wasting in patients already on nerve-targeted treatment.
Biogen reports $2.74B Q2 revenue, up 3% and beating estimates. Growth products surge 24%, rare-disease drugs rise 11%.
Despite missing the primary endpoint, the drug advances to Phase 3 in 2027 with a favorable safety profile.
RBC keeps Outperform at $242, Truist upgrades to Buy ($235 target).
The deal adds multiple early-stage small-molecule immunology assets to Biogen’s pipeline, with the lead candidate entering Phase 1 in Q3 2026.
Biogen’s new SMA drug Salanersen shows strong early results, helping kids move better. FDA fast-tracks it with Breakthrough status.