Scholar Rock tumbles after FDA action on manufacturing site

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