Scholar Rock is trading 8.21% up at $59.96 after the FDA approved ISEMBYLD on September 11, 2026, the company’s first approved treatment for spinal muscular atrophy.

  • Authorized for adults and children aged two and older receiving SMN2-targeted treatment; commercial shipments begin shortly.
  • Investor call scheduled for 8:00 a.m. ET on September 14.
  • The company-specific FDA decision outweighs the weaker broader-market pre-market backdrop.