Scholar Rock Holding Corporation

Scholar Rock Holding Corporation maintains a "Strong Buy" rating following FDA approval of ISEMBYLD [apitegromab] for SMA in patients ≥2 years old. SRRK targets a $2B+ market opportunity in SMA, with expansion potential into younger populations, subcutaneous formulations, and new indications like FSHD. Regulatory catalysts include planned MAA resubmission in Europe and anticipated JNDA filing in Japan by year-end 2026, leveraging a validated manufacturing facility.

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Scholar Rock Holding Corporation (SRRK) Discusses FDA Approval and Clinical Impact of ISEMBYLD in SMA Treatment Transcript

The U.S. Food and Drug Administration on Friday approved ISEMBYLD (apitegromab-mstn) from Scholar Rock (NASDAQ:SRRK) for spinal muscular atrophy (SMA) in adults and pediatric patients aged 2 years and older.