Scholar Rock price target lowered to $44 from $50 at H.C. Wainwright

H.C. Wainwright lowered the firm’s price target on Scholar Rock (SRRK) to $44 from $50 and keeps a Buy rating on the shares after the FDA issued a Complete Response Letter for apitegromab in spinal muscular atrophy. The CRL stemmed “solely” from unresolved compliance observations at the Indiana fill-finish facility now owned by Novo Nordisk (NVO), notes the analyst, who also points out that no deficiencies were cited with apitegromab with no concerns expressed around clinical efficacy, safety, or drug substance manufacturing. The firm, which believes a 6-12 month delay is likely, calls this “disappointing and avoidable,” but adds that such a delay does not alter the drug’s ultimate approvability or market potential.