Scholar Rock Shares Jump as Apitegromab BLA Resubmitted to FDA for SMA Treatment
Scholar Rock resubmits its BLA for apitegromab to treat SMA. FDA acceptance expected in 30 days, PDUFA target late September 2026.
Scholar Rock resubmits its BLA for apitegromab to treat SMA. FDA acceptance expected in 30 days, PDUFA target late September 2026.
Roche halts emugrobart development, clearing path for Scholar Rock's apitegromab to dominate SMA muscle therapy market. Cantor sees multi-billion potential.
Scholar Rock (SRRK) shares jump 23% after constructive FDA meeting regarding apitegromab treatment for spinal muscular atrophy, with 2026 approval anticipated.
Bank of America initiates coverage of Scholar Rock with Buy rating and $53 price target, citing apitegromab's breakthrough potential in spinal muscular atrophy treatment with $2B peak sales forecast.
Scholar Rock’s potential new SMA treatment, Apitegromab, received a delay from the FDA due to manufacturing site issues, not the drug's safety or effectiveness.