tradingkey.logo

Scholar Rock tumbles after FDA action on manufacturing site

ReutersOct 13, 2025 3:15 PM

** Shares of drug developer Scholar Rock SRRK.O fall 21.3% to $31

** SRRK says on Friday Novo Nordisk NOVOb.CO has informed the company the U.S. FDA has classified its Catalent, Indiana manufacturing site as "official action indicated," following an inspection earlier this year

** The classification means the FDA found compliance issues that may require regulatory action

** Scholar Rock has requested a Type A meeting with the FDA to discuss next steps for resubmission of apitegromab

** BMO analysts says the announcement was expected but paints a more difficult path forward for SRRK, adding that "there is a lot that needs to be fixed at Catalent"

** The Catalent, Indiana site was acquired by Novo Nordisk's parent, last year, for $16.5 billion

** More details are expected during its third-quarter business update in November - SRRK

** Including session moves, stock down 28% YTD

Disclaimer: The information provided on this website is for educational and informational purposes only and should not be considered financial or investment advice.

Related Articles

KeyAI