Scholar Rock is trading 11.89% up in pre-market at $62.00 after the FDA approved ISEMBYLD on September 11, 2026, the company’s first approved treatment.

  • It is authorized for adults and children aged two and older with spinal muscular atrophy receiving SMN2-targeted treatment.
  • Commercial shipments are expected to begin shortly, supporting the strong pre-market reaction.
  • Reuters and the company confirmed the approval and its clinical basis.