Scholar Rock wins FDA approval, launches ISEMBYLD in U.S.

Scholar Rock (SRRK) says the FDA approved ISEMBYLD for SMA patients on SMN2 therapy and that it has launched U.S. supply. The company plans EU and Japan filings, expects U.S. pricing at about $11,659 per vial (~$310k/year), and is planning PRV sale. Markets highlight an analyst price-target upgrade following the approval, with Scholar Rock citing about $492M cash plus potential $150M debt.