SRRK FDA decision on apitegromab for SMA expected by September 30
TradingView News says a decision from the FDA on apitegromab for SMA is expected by September 30 after resolving manufacturing issues and moving production to an alternate facility. Global launches are planned.
Apitegromab is nearing FDA approval for SMA, with a decision expected by September 30 after the company resolved manufacturing issues and moved production to an alternate facility. The company also said global expansion is underway, with EMA and PMDA filings planned, while its clinical pipeline continues to progress and financial backing remains strong.