Is this U.S.-China selloff a buy? A top Wall Street voice weighs in
Investing.com - H.C. Wainwright lowered its price target on Scholar Rock (NASDAQ:SRRK) to $44 from $50 while maintaining a Buy rating after the company received a Complete Response Letter (CRL) from the FDA for its spinal muscular atrophy drug apitegromab. Currently trading at $33.75 with a market cap of $3.2 billion, the stock remains within analysts’ target range of $43-$54. According to InvestingPro analysis, the stock appears overvalued at current levels.
The CRL, issued on September 23, stemmed solely from unresolved compliance issues at a Catalent Indiana fill-finish facility now owned by Novo Nordisk, with no deficiencies cited regarding the drug itself or concerns about clinical efficacy, safety, or drug substance manufacturing.
H.C. Wainwright noted that label negotiations had been nearly finalized prior to the decision, indicating the drug remains fully approvable once the manufacturing facility issues are resolved.
Scholar Rock plans to request a Type A meeting with the FDA within 30 days to define resubmission requirements, which will focus exclusively on the facility’s remediation plan, potentially resulting in either a two-month Class I review or a six-month Class II review.
Based on historical precedent, H.C. Wainwright anticipates a 6-12 month delay in approval, but maintains that this setback does not alter apitegromab’s ultimate approvability or market potential.
In other recent news, Scholar Rock received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration for its spinal muscular atrophy treatment, apitegromab. The FDA’s decision was based on observations during a routine inspection of Catalent Indiana LLC, a third-party facility, which did not directly concern the drug’s efficacy or safety. This development has led Leerink Partners to lower its price target for Scholar Rock from $51.00 to $48.00, though it maintained an Outperform rating, citing a revised U.S. launch timeline to the second quarter of 2026.
Additionally, Barclays initiated coverage on Scholar Rock with an Overweight rating and set a price target of $45.00. Jefferies also began coverage, giving the company a Buy rating and a $50.00 price target, expressing optimism about apitegromab’s potential approval for a broad patient label. These recent developments highlight ongoing interest and varied expectations from analysts regarding Scholar Rock’s future performance.
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