FDA decision on apitegromab for SMA expected by September 30
核心洞察
Scholar Rock expects an FDA decision on apitegromab for spinal muscular atrophy (搜索) by September 30, after resolving manufacturing issues and moving to an alternate facility.
The company plans global expansion for apitegromab, with regulatory filings planned with the European Medicines Agency (搜索) and Japan's PMDA.
Scholar Rock reported progress across its clinical pipeline and said it has financial backing to support commercialization and future growth.
Scholar Rock Holding Corporation (搜索) expects a US Food and Drug Administration decision on apitegromab for spinal muscular atrophy (搜索) by September 30, according to remarks at the 12th Annual Cantor Fitzgerald Global Healthcare Conference. The company said manufacturing issues tied to the drug have been resolved and production has transitioned to an alternate facility.
Global expansion for apitegromab is underway, with filings planned with the European Medicines Agency (搜索) and Japan's Pharmaceuticals and Medical Devices Agency. Scholar Rock also cited progress across its clinical pipeline and said it has financial backing in place for commercialization and future growth.