Scholar Rock drops Novo manufacturing site from SMA drug application
Scholar Rock drops Novo manufacturing site from SMA drug application
Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role. Its lead product, apitegromab, is being developed for spinal muscular atrophy (SMA).
Apitegromab BLA submission decision
SRK-439 Phase 1 initial data
Scholar Rock drops Novo manufacturing site from SMA drug application
Despite earlier claims of improvement at the fill-finish plant, the FDA has classified the facility as Official Action Indicated based on inspection findings.
Scribe's $96M IPO; Scholar Rock awaits site classification for apitegromab.
Chief Executive Officer
Chief Scientific Officer
Chief Financial Officer