FDA grants Priority Review to Humacyte's HAV BLA; PDUFA date August 10, 2024

Humacyte, Inc.

BLA for Human Acellular Vessel in urgent arterial repair after extremity vascular trauma accepted with Priority Review.
PDUFA action date set for August 10, 2024; six-month review vs. standard ten months.
Supporting data from Phase 2/3 V005 trial and real-world use in Ukraine wartime injuries.
HAV showed higher patency, lower amputation and infection rates versus historic synthetic graft benchmarks.
Priority Review aligns with prior RMAT designation and DoD priority designation under Public Law 115-92.

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