The company stated that the FDA did not make any observations specific to the drug or cite any other approvability concerns, including any pertaining to Apitegromab’s efficacy and safety data.
Shares of Scholar Rock (SRRK) rose about 2% on Tuesday morning after falling 12% in the pre-market session after the U.S. Food and Drug Administration refused to approve its Apitegromab drug for the treatment of patients with spinal muscular atrophy (SMA).
The company stated that the FDA raised concerns identified during a routine general site inspection of Catalent Indiana LLC, a third-party fill-finish facility. The agency did not make any observations specific to its drug or cite any other approvability concerns, including any pertaining to Apitegromab’s efficacy and safety data, the company said.
Catalent Indiana was acquired by Danish drugmaker Novo Nordisk (NVO) in December. The facility submitted a response in early August 2025 to address the observations noted by the FDA and has continued to take corrective actions, the company said.
Scholar Rock said it will resubmit its application for Apitegromab once Catalent Indiana’s issues with the FDA are resolved. The company stated that it believes the FDA will be able to act expeditiously on the application once the manufacturing issues have been resolved. “We are continuing to work closely with Catalent Indiana on the FDA’s manufacturing observations so that we can resubmit the apitegromab BLA (application) as soon as possible,” said CEO David L Hallal.
Scholar Rock has also submitted Apitegromab for approval by the European Medicines Agency, and a decision is anticipated near mid-2026, the company said. It expects a European launch for the drug in the second half of 2026, starting with Germany.
Scholar Rock believes Apitegromab may lead to a clinically meaningful improvement in motor function in patients with Spinal Muscular Atrophy (SMA), a rare, severe, genetic neuromuscular disease characterized by motor function decline.
On Stocktwits, retail sentiment around SRRK stock jumped from ‘bullish’ to ‘extremely bullish’ territory over the past 24 hours, while message volume stayed at ‘extremely high’ levels.
Scholar Rock is not the only company whose submissions have been delayed or denied following the FDA’s site inspection at Catalent’s Indiana facility. Last month, Regeneron (REGN) announced that the FDA had extended the date by which it is expected to rule on two of its EYLEA HD Injection regulatory submissions due to issues identified at the facility.
SRRK stock is down 23% this year but up approximately 282% over the past 12 months.
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