04:35 PM EDT, 08/09/2024 (MT Newswires) -- Humacyte ( HUMA ) shares fell about 16% in recent trading Friday after the company said the US Food and Drug Administration will require additional time to complete the review of its biologics license application for the acellular tissue engineered vessel in the vascular trauma indication.

The FDA assigned a Prescription Drug User Fee Act date of Aug. 10 to complete the review, according to the company.

"We received a call from FDA CBER leadership this afternoon apologizing to us and stating that additional time was required for review." said CEO Laura Niklason. "The FDA leadership expressed an apology for their inability to complete the review by the PDUFA date, and currently we do not yet have a revised action date."

Price: 6.60, Change: -1.31, Percent Change: -16.56