SRRK Scholar Rock provides update on timing of committee for medicinal products for human use (chmp) opinion for apitegromab marketing autho
SRRK Scholar Rock provides update on timing of committee for medicinal products for human use (chmp) opinion for apitegromab marketing authorisation application (maa) for spinal muscular atrophy (sma) Scholar Rock holding Corp - apitegromab chmp opinion expected after Catalent Indiana classification or second facility inclusion - Chmp opinion expected later in 2026 if FDA reclassifies Catalent Indiana - Apitegromab BLA under FDA review with Sept 30, 2026 pdufa date
SRRK Scholar Rock provides update on timing of committee for medicinal products for human use (chmp) opinion for apitegromab marketing authorisation application (maa) for spinal muscular atrophy (sma) Scholar Rock holding Corp - apitegromab chmp opinion expected after Catalent Indiana classification or second facility inclusion - Chmp opinion expected later in 2026 if FDA reclassifies Catalent Indiana - Apitegromab BLA under FDA review with Sept 30, 2026 pdufa date