Scholar Rock Discusses Apitegromab Ahead of FDA PDUFA Date at Biopharma Summit
Scholar Rock highlights 15 years since its founding and says it is about three weeks from an FDA PDUFA date for apitegromab, a monoclonal antibody myostatin inhibitor. The company describes Phase III results in 188 patients with spinal muscular atrophy, citing statistically meaningful motor function improvement on the Hammersmith Motor Function Scale and frames the approach for muscular atrophies and dystrophies.