Clinical DevelopmentApitegromab is the first myostatin-targeting therapy to show a statistically significant benefit in motor function in a pivotal trial.
Market PotentialThere is a significant market opportunity for apitegromab in SMA, with risk-adjusted peak sales modeled at $2bn in 2037.
Regulatory Approval ProgressSRRK held their Type A meeting with FDA to discuss the re-submission of their BLA for apitegromab in spinal muscular atrophy, highlighting constructive dialogue with FDA and now anticipating re-submission, approval, and US launch in 2026.