Scholar Rock has shed Novo Nordisk’s troubled Catalent facility as a contract manufacturer in its FDA refiling for apitegromab, a candidate for spinal muscular atrophy.
The Cambridge, Massachusetts-based biotech announced the move Friday, while assuring investors of the FDA’s target decision date of Sept. 30.
The decision comes a year after problems at the legacy Catalent fill-finish facility in Bloomington, Indiana, triggered a complete response letter for Scholar Rock’s original application for apitegromab.
The FDA slapped the facility with a Form 483 in July 2025, then escalated it to a warning letter in November.
Since the original snub, Scholar Rock has refiled apitegromab in March 2026, listing two third-party fill-finish facilities, including the Catalent site and another U.S.-based facility “producing numerous commercial products,” according to its announcement Friday. However, another inspection of the Catalent site in April 2026 again led to a Form 483.
When Scholar Rock CEO David Hallal hopped on the company’s second-quarter earnings call on Thursday, the FDA had not issued an official classification of the April 2026 inspection. At the time, Hallal touted his firm’s optionality with two available facilities, whichever is found to be the most rapid.
That changed on Friday, when Novo alerted Scholar Rock that the agency has issued an “Official Action Indicated” (OAI) designation, which indicates serious violations that require follow-up enforcement.
“We view this as part of an ongoing process and remain focused on the work already underway to address the agency's observations, as the quality of the medicines we make remains a top priority,” a Novo spokesperson said of the OAI in a statement to Fierce Pharma.
“Over the past year, Novo Nordisk has invested significant resources in improving operations and enhancing quality systems at the facility,” the spokespon added. “Site Bloomington remains an important part of Novo Nordisk's operations, and we will continue working collaboratively and transparently with the FDA as we move forward.”
Still, Scholar Rock is shifting all its apitegromab application to the second facility.
“[T]he FDA review of the facility is advancing, robust supply for commercialization is ready and awaiting packaging and labeling at a third-party site, and importantly, the facility has demonstrated a strong track record of compliance, including recent successful FDA and EMA inspections,” Hallal said of the second plant in an Aug. 7 statement.
Outside the U.S., Scholar Rock’s application for apitegromab includes only the Catalent site, as the European Medicines Agency is holding its ruling in anticipation of the FDA’s inspection classification. The company is in discussions with European regulators to potentially use the second fill-finish facility, Hallal said on Thursday’s call.
Before Scholar Rock, Regeneron had to switch manufacturing away from the Catalent facility to overcome an FDA complete response letter for the prefilled syringe version of its high-dose Eylea. Regeneron has another recent FDA rejection tied to manufacturing issues at the Catalent facility—for its CD20xCD3 bispecific antibody odronextamab.
The OAI may disrupt regulatory plans for other companies. Issues at the legacy Catalent plant, which Novo inherited as part of Novo Holdings’ acquisition of the CDMO in 2024, recently tripped up Incyte’s FDA bid for its PD-1 inhibitor Zynyz in first-line non-small cell lung cancer.
“Catalent Indiana is the primary third-party fill-finish manufacturer for Zynyz,” Incyte said in a statement to Fierce Pharma. “We have not experienced safety or product quality issues related to Zynyz.”