Humacyte: FDA Grants Priority Review To BLA Seeking Approval Of Human Acellular Vessel

(RTTNews) - Humacyte, Inc. (HUMA) announced the FDA has accepted and granted Priority Review to Biologics License Application seeking approval of the Human Acellular Vessel in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible. The PDUFA date, the FDA action date for their regulatory decision regarding the BLA, is August 10, 2024.

The company noted that its BLA submission is supported by positive results from the V005 Phase 2/3 clinical trial, as well as real-world evidence from the treatment of wartime injuries in Ukraine under a Humanitarian Aid Program supported by the FDA.

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