Why Is Clinical-Stage Biotechnology Platform Company Humacyte Stock Gaining Friday?

Humacyte, Inc. HUMA shares are trading higher on Friday.

The company announced that the U.S. FDA has accepted and granted Priority Review to Humacyte’s Biologics License Application (BLA) seeking approval of the Human Acellular Vessel (HAV).

HAV is used in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated and when autologous vein use is not feasible.

“We are very pleased that the FDA has accepted our BLA and has recognized the potential importance of the HAV technology by granting us Priority Review,” said Laura Niklason, Chief Executive Officer of Humacyte.

The 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. 

The HAV was observed to have higher rates of patency (blood flow), and lower rates of amputation and infection, as compared to historic synthetic graft benchmarks.

The HAV can be produced at commercial scale in Humacyte’s existing manufacturing facilities, which are expected to have the capacity to provide thousands of vessels for treating patients in need.

The Prescription Drug User Fee Act date and the FDA action date for their regulatory decision regarding the BLA is August 10, 2024.

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Price Action: HUMA shares are trading higher by 14.2% to $3.58 on the last check Friday.