As Novo Nordisk cuts 400 jobs at the troubled site, Scholar Rock has seen enough progress that it included the facility in a resubmission for FDA approval.
There have been signs in recent weeks that Novo Nordisk’s troubled Bloomington, Indiana, production plant is getting back on track, with the company’s clients reporting positive meetings with the FDA and the resumption of routine manufacturing at the site. Yet Novo is reducing headcount at the facility.
A company spokesperson told BioSpace via email that it will lay off about 400 people at the site at the start of May but that Novo continues to invest in the facility. Following the cuts, Novo will employ about 1,400 people at the plant. Amid slowing sales growth at its GLP-1 franchise, the company moved to eliminate about 9,000 positions last year.
Novo’s parent company Novo Holdings acquired the Bloomington plant when sales of the company’s GLP-1 drugs Ozempic and Wegovy were outpacing supply. Because the site was previously owned by Catalent, a contract manufacturing organization, Novo took on customers as part of its acquisition of the plant.
Quality problems at the facility led the FDA to issue complete response letters to Incyte, Regeneron and Scholar Rock, all of which outsource fill/finish activities to the plant. The FDA set out its concerns in a warning letter late last year, flagging quality failings including inadequate investigations of “mammalian hair” contamination.
FDA inspectors assessed the site in June and July and sent the warning letter in October. Speaking at a Barclays event last month, Scholar Rock CEO David Hallal said that Novo “hadn’t really had a constructive communication pathway with the FDA” until his team invited the Danish drugmaker to a meeting with the agency in November.
Hallal said Novo’s “first audience with the FDA was really November of ’25,” despite the inspection that found fault with the facility in July. Progress has been “extremely rapid” since Novo met the FDA, Hallal added. Novo responded to the warning letter in mid-December, and the agency scheduled a meeting for early 2026.
With neither the meeting nor subsequent field visit raising new remediation tasks, Scholar Rock refiled for FDA approval of its spinal muscular atrophy drug candidate apitegromab this week. The filing includes the Bloomington site and a second fill/finish facility that was absent from Scholar Rock’s original approval application. The FDA has yet to reinspect the Bloomington facility.
Hallal said on a call with analysts that filing timing reflects “significant progress” at Bloomington. Scholar Rock made the filing decision in alignment with the FDA. The decision to refile without a reinspection “appears to speak to either the resolution of Catalent issues soon or confidence in commercial readiness supported by the second fill/finish site,” BMO Capital Markets analysts said in a note to investors on Tuesday.
Hallal said including two sites in the filing gives Scholar Rock the flexibility to drop one facility, move forward with an approval and add the second plant to the authorization after apitegromab comes to market.
