Scholar Rock wins FDA approval for Isembyld

14 September 2026

US biotech Scholar Rock (Nasdaq: SRRK) announced that the US Food and Drug Administration (FDA) has approved Isembyld (apitegromab-mstn) for the treatment of spinal muscular atrophy (SMA) in adults and children two years of age and older who are currently receiving a survival motor neuron 2 (SMN2)-targeted treatment. The company’s shares rose 11.8% to $61.97 in after-hours trading following the announcement late Friday.

SMA is a rare, severe neuromuscular disease that results in irreversible loss of motor neurons and progressive muscle wasting, causing continuous motor function decline throughout life and diminishing the independence of both adults and children.

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