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FDA Approves Isembyld (apitegromab-mstn), the First and Only Muscle-Targeted Therapy for Spinal Muscular Atrophy, Marking a New Milestone in SMA Treatment

GlobeNewswire

New York, Sept. 11, 2026 -- The Muscular Dystrophy Association (MDA) marks another milestone for the neuromuscular community with the U.S. Food and Drug Administration (FDA) approval of Isembyld (apitegromab-mstn), a monthly infusion treatment for people living with spinal muscular atrophy (SMA) who are currently receiving a survival motor neuron 2 (SMN2)-targeted treatment. Isembyld (apitegromab-mstn) is the first and only muscle-targeted therapy for SMA, offering new hope for children and adults living with this neuromuscular disease. SMA is a leading genetic cause of death in infants and often requires lifelong support to maintain mobility, breathing, and independence. Today, with more treatments available, people are living longer, more independent lives. Read Scholar Rock’s announcement here.

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