Novo plant hit with FDAs most serious inspection classification, portending possible delays for partners
6.5
来源：
FiercePharma
发布时间：
2025-10-13 15:12
摘要：
Novo Nordisk's Indiana manufacturing facility has been classified by the FDA as having serious compliance issues, which could lead to significant delays in drug approvals for companies like Scholar Rock and Regeneron. Scholar Rock's SMA treatment application is particularly affected, resulting in a 12% drop in its stock price. The situation underscores the investment risks in the biotech sector, especially concerning manufacturing reliability.
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关键证据
FDA tagged the facility with an OAI label, indicating serious compliance issues.
Scholar Rock's share price tumbled by roughly 12% due to the news.
Regeneron announced delays in FDA decisions due to manufacturing issues at the Novo plant.
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AI评分总结
Novo Nordisk's Indiana manufacturing facility has been classified by the FDA as having serious compliance issues, which could lead to significant delays in drug approvals for companies like Scholar Rock and Regeneron. Scholar Rock's SMA treatment application is particularly affected, resulting in a 12% drop in its stock price. The situation underscores the investment risks in the biotech sector, especially concerning manufacturing reliability.