Humacyte's (HUMA) ATEV BLA Review Period Extended by FDA

Humacyte, Inc. (HUMA) announced a delay in the FDA's review of its Biologic License Application (BLA) for its Acellular Tissue Engineered Vessel (ATEV). The FDA, which had granted a Priority Review to this pioneering vascular trauma treatment, now requires additional time beyond the original Prescription Drug User Fee Act (PDUFA) date of Aug 10, 2024, to complete its evaluation. Despite the delay, Humacyte remains confident about ATEV's potential approval and its transformative role in trauma care. Humacyte ...