Shares of drug developer Scholar Rock SRRK.O rise 6.2% to $46.16 premarket
SRRK, in its earnings release, says it plans to resubmit application to market its experimental drug, apitegromab, to treat muscle disorder known as spinal muscular atrophy (SMA)
Company says the move follows meeting with U.S. FDA and Catalent's Indiana facility, after which the regulator determined that no further action was required
Apitegromab was previously declined approval in U.S. after drug regulator found issues arising from routine inspection of Catalent's Indiana fill-finish facility, which is owned by Novo Nordisk NOVOb.CO
SRRK is banking on apitegromab to drive its growth and profitability
The drug is also being tested for muscle preservation in obesity
As of last close, SRRK stock was down 1.3% YTD