On August 9, 2024, Humacyte, Inc. announced that the U.S. Food and Drug Administration (FDA) required additional time to complete its review of the Biologic License Application (BLA) for its acellular tissue engineered vessel (ATEV) in the vascular trauma indication. The FDA indicated that it had conducted inspections of Humacyte's manufacturing facilities and clinical sites.
The agency also stated it had actively engaged with the company in multiple discussions regarding the BLA filing. This delay extends the review period for a product that was granted Priority Review, impacting the expected timeline for potential market approval.
The need for additional review time introduces uncertainty for Humacyte's lead product candidate, which is designed to be a universally implantable vascular conduit for arterial replacement and repair.
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