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Scholar Rock tumbles after FDA action on manufacturing site

RefinitivMeno di 1 minuto di lettura

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

** SRRK says on Friday Novo Nordisk NOVO_B 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

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