Scholar Rock has removed Novo Nordisk’s Catalent manufacturing facility from its FDA submission for apitegromab, a spinal muscular atrophy treatment candidate, following a damaging inspection outcome.
The troubled plant received an “Official Action Indicated” classification from the FDA, signalling serious regulatory violations that require follow-up enforcement action from the agency.
Scholar Rock had originally refiled apitegromab in March 2026, listing two third-party fill-finish facilities, including the Catalent site alongside a separate U.S.-based facility currently producing numerous commercial products.
A further inspection of the Catalent site in April 2026 again resulted in a Form 483, compounding existing concerns about the plant’s compliance standing with federal regulators.
Scholar Rock CEO David Hallal, speaking on the company’s second-quarter earnings call, initially highlighted the firm’s optionality in having two available manufacturing sites to support the regulatory submission.
Novo alerted Scholar Rock on Friday that the April 2026 inspection had received an official OAI designation, prompting the company to withdraw the Catalent location from its submission entirely.
Working under the guidance of the FDA, Scholar Rock confirmed the agency’s evaluation will now proceed solely relying on the alternative U.S.-based site, which holds a strong regulatory track record.
Despite the manufacturing pivot, the Prescription Drug User Fee Act action date for apitegromab remains firmly on track for September 30, offering some reassurance to investors and patients awaiting the treatment.
The alternative facility manufactures multiple commercial products and maintains a solid standing with both the FDA and the European Medicines Agency, strengthening Scholar Rock’s regulatory position going forward.
The OAI designation at the legacy Catalent plant, which Novo inherited following Novo Holdings’ acquisition of the contract development and manufacturing organisation in 2024, has created broader regulatory disruption across the industry.
Incyte’s FDA bid for its PD-1 inhibitor Zynyz in first-line non-small cell lung cancer was recently tripped up by issues connected to the same Indiana facility, representing another significant setback linked to the site.
Incyte confirmed in a statement that the Catalent Indiana site is the primary fill-finish manufacturer for commercial supply of Zynyz, and that it has “not experienced safety or product quality issues” for marketed products.
Regeneron is also working to mitigate risks associated with the troubled Indiana plant, pursuing approvals through multiple CDMOs for a prefilled syringe version of eye disease drug Eylea HD.
Novo Nordisk has remained tight-lipped about whether its own FDA applications have been affected by quality problems at the ex-Catalent facility, leaving questions unanswered about the wider regulatory impact.