Scholar Rock Holding CorpRemoving Catalent site and keeping PDUFA date reduces regulatory risk for apitegromab BLA.
Scholar Rock Holding Corporation is removing the Catalent Indiana fill-finish facility, now part of Novo Nordisk, from its apitegromab Biologics License Application after the FDA classified an April 2026 site inspection as Official Action Indicated. The company pivoted exclusively to its second fill-finish facility, submitted the data package ahead of schedule, and confirmed robust commercial supply, keeping the apitegromab BLA on track for its September 30, 2026 PDUFA date. Scholar Rock reported a narrower-than-expected Q2 2026 net loss of $0.84 per share, or $109.9 million, and exited the quarter with $492 million in cash. BMO Capital raised its price target to $76 from $70, citing confidence ahead of the apitegromab decision. Novo Nordisk, the parent of the Catalent site, reported an 11% increase in adjusted operating profit to DKK 33.38 billion, but its reported operating profit dropped 16% to DKK 27.06 billion due to non-cash impairment charges of DKK 6.3 billion and unfavorable comparisons to prior-year US 340B rebate provision reversals, leading Citi to lower its price target to DKK 310 from DKK 330 and call the quarter messy.
Scholar Rock Holding CorpRemoving Catalent site and keeping PDUFA date reduces regulatory risk for apitegromab BLA.
Novo Nordisk A/SReported operating profit dropped 16% due to impairments and unfavorable comparisons, leading to price target cut.
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