The FDA approved Scholar Rock’s myostatin inhibitor apitegromab, marketed as Isembyld, for spinal muscular atrophy. The decision clears the therapy for use alongside existing targeted treatments in adults and children at least 2 years old who are receiving survival motor neuron 2-targeted therapy. The approval arrives after manufacturing-related delays that previously held up the program and required additional FDA clearance steps. With the clearance, Scholar Rock enters a competitive landscape for SMA where disease-modifying options already exist but differ in functional outcomes. Executives signaled commercial scale expectations during launch preparation, while the approval’s conditional positioning alongside other therapies suggests Isembyld is being evaluated for additive motor-function benefit rather than replacing current standards.