BUZZ-Scholar Rock falls on FDA review; analysts flag optimistic expectations

-1.46%

SCHOLAR ROCK HOLDING CORP

SRRK

45.98

-1.46%

** Shares of drug developer Scholar Rock SRRK.O down 2.5% at $41.12

** SRRK says U.S. FDA has scheduled meeting with third-party manufacturing facility, Catalent Indiana, part of Novo Nordisk NOVOb.CO, in early 2026 to discuss progress of remediation efforts

** Expects resubmission of marketing application of apitegromab for muscle weakness and U.S. launch following FDA's potential approval in 2026

** In September, agency declined to approve apitegromab citing issues at the facility

** "Catalent site could take time to be resolved" - Truist analyst Srikripa Devarakonda

** Adds: "This is in-line with our model baseline assumptions of H1 2026 or mid-2026 submission of BLA and 2027 launch"

** SRRK expects to submit a supplemental application for apitegromab to treat facioscapulohumeral muscular dystrophy with second site later in 2026

** Stock fell 7.3% in 2025

(Reporting by Siddhi Mahatole)

((siddhi.mahatole@thomsonreuters.com))

More This page is machine-translated. Sahm tries to improve but does not guarantee the accuracy and reliability of the translation, and will not be liable for any loss or damage caused by any inaccuracy or omission of the translation. *Disclaimer: The above content only represents the author's personal position and opinion and does not represent any position of Sahm Capital Financial Company and Sahm cannot confirm the authenticity, accuracy, and originality of the above content. Investors should consider the risks of investment products in light of their circumstances before making any investment decisions. When necessary, please consult a professional investment advisor. Sahm does not provide any investment advice, nor does it make any commitments and guarantees.