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June 5, 2026

Biogen’s salanersen gains FDA breakthrough therapy designation for SMA

Biogen has received the breakthrough therapy designation from the US Food and Drug Administration (FDA) for salanersen (BIIB115), an investigational treatment for spinal muscular atrophy (SMA).

SMA is a rare, genetic neuromuscular disease leading to progressive muscle weakness due to the loss of motor neurons. Credit: Panchenko Vladimir / Shutterstock.com.