Scholar Rock price target lowered to $51 from $52 at Piper Sandler

Piper Sandler analyst Allison Bratzel lowered the firm’s price target on Scholar Rock (SRRK) to $51 from $52 and keeps an Overweight rating on the shares following the issuance of a complete response letter from FDA regarding apitegromab in SMA, announced one day after its PDUFA date, and based solely on CMC observations at a third-party fill-finish facility. Importantly, management noted that no other issues related to approvability were cited in the CRL and that Catalent Indiana continues to work on resolving these CMC issues. The firm connected with management and learned that they plan to convene a Type A meeting with FDA, anticipated around the end of October, to understand the issues more fully and then share plans for a BLA resubmission. This represents a temporary regulatory setback, delaying the anticipated U.S. commercial launch beyond Q4 2025, but does not impact our long-term conviction in apitegromab’s multiblockbuster potential in SMA alone. Piper remains a buyer.