FDA Approves First SMA Drug That Targets Muscle Loss, Not Just Nerves
The FDA approved Scholar Rock’s Isembyld, the first SMA therapy aimed at muscle wasting in patients already on nerve-targeted treatment.
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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.
Roche Abandons Emugrobart – Clears Path for Scholar Rock’s Apitegromab to Dominate SMA
Roche halts emugrobart development, clearing path for Scholar Rock's apitegromab to dominate SMA muscle therapy market. Cantor sees multi-billion potential.
Scholar Rock Soars 23% on Positive FDA Meeting for SMA Treatment
Scholar Rock (SRRK) shares jump 23% after constructive FDA meeting regarding apitegromab treatment for spinal muscular atrophy, with 2026 approval anticipated.
BofA Initiates Scholar Rock with Buy Rating: $53 Target on Promising SMA Therapy
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 Apitegromab Application Declined by FDA Due to Manufacturer Issues
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.