On September 23, Scholar Rock Holding Corp rose 5.09% in regular trading, trading at $50.68/share, with turnover of approximately $68.36 million. The stock continues to trade actively following a series of major catalysts centered on the FDA approval and commercial launch of its flagship drug.

The FDA approved Isembyld (apitegromab-mstn) on September 12 for treatment of spinal muscular atrophy in patients aged two and older, making it the first and only muscle-targeted therapy for SMA. The company immediately initiated U.S. commercial shipments. Management disclosed a wholesale acquisition cost of $11,659 per vial, with estimated annual net treatment costs for a typical U.S. patient approaching $310,000. Truist Securities raised its price target to $76 from $55 while maintaining a Buy rating, and the analyst consensus target stands at $65.60, well above current levels.

The stock had pulled back on September 16 after Barclays downgraded it to Equalweight from Overweight, though it simultaneously raised its target to $58. Truist also flagged potential early commercialization friction from FDA-required post-marketing pregnancy safety studies and 15-day fracture reporting, but noted observed fracture rates appear consistent with historical SMA patient data.

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