Scholar Rock Holding Corp 8K

Scholar Rock received FDA approval and initiated U.S. launch of ISEMBYLD (apitegromab-mstn) for SMA patients aged ≥2 on SMN2-targeted therapy, marking its first commercial product and a major strategic milestone.

Scholar Rock, Inc. announced that the U.S. Food and Drug Administration has approved ISEMBYLD (apitegromab-mstn), the first and only FDA-approved, muscle-targeted myostatin inhibitor therapy for the treatment of spinal muscular atrophy (SMA) in adults and children 2 years of age and older who are currently receiving an SMN2-targeted treatment, and that the U.S. commercial launch is now underway with supporting patient services, distribution infrastructure, and a plan to expand globally, while the company begins to recognize product revenue and considers monetization of its Rare Pediatric Disease Priority Review Voucher within a strong liquidity position.

Filing Facts

CIK

1727196

Ticker

SRRK

Form

8K

Source Type

fda

Accession

0001104659-26-107273

Alert Tier

8