The FDA decision on Scholar Rock Holding Corp.'s (SRRK) investigational muscle-targeted treatment Apitegromab is anticipated on September 22, 2025.Apitegromab is being developed to provide a clinically meaningful improvement in motor function for people living with spinal muscular atrophy who are receiving an SMN-targeted treatment (Biogen/Scholar Rock’s Spinraza or Roche’s Evrysdi).Spinal muscular atrophy (SMA) is a rare, genetic neuromuscular disease that afflicts an estimated 30,000 to 35,000 people in the United States and Europe. It is primarily caused by mutations in the SMN1 gene (Survival Motor Neuron 1), leading to a deficiency of the SMN protein - a molecule critical for the survival and proper functioning of motor neurons. The deficiency of the SMN protein leads to loss of motor neurons, atrophy of the voluntary muscles of the limbs and trunk, and progressive muscle weakness. If approved, Apitegromab has the potential to achieve blockbuster sales at its peak, according to analysts. SRRK closed Wednesday’s (Aug.27, 2025) trading at $34.47, up 2.04%.