Browsing Tag
Apitegromab
2 posts
Scholar Rock keeps apitegromab FDA decision alive as Europe filing is reset
Scholar Rock has removed Catalent Indiana from the U.S. apitegromab application while keeping its September 30 FDA decision date intact, but the manufacturing issue has forced a European filing withdrawal and resubmission.
Why Scholar Rock believes apitegromab could still become a major SMA therapy despite FDA delays
Scholar Rock targets a 2026 BLA resubmission and potential launch for apitegromab in spinal muscular atrophy. Discover what it means for the SMA market.