SRRK: FDA decision on apitegromab for SMA expected by Sept. 30
SRRK’s apitegromab for SMA is nearing FDA approval, with a decision expected by September 30 after manufacturing issue resolution and a move to an alternate facility.
Apitegromab is approaching an FDA decision for SMA, with the agency expected to rule by September 30 after manufacturing issues were resolved and production moved to an alternate facility. Global launch preparations are under way, while regulatory filings are planned in Europe and Japan. The company also says its clinical pipeline remains active.