Humacyte: FDA Extends Time To Review ATEV For Vascular Trauma Indication

(RTTNews) - Shares of Humacyte, Inc. (HUMA) fell more than 10% in after-hours trading Friday after the Food and Drug Administration said it will require more time to review acellular tissue engineered vessel (ATEV) in the vascular trauma indication.

The ATEV trauma program BLA was submitted to FDA in December 2023, and the FDA granted a Priority Review in February 2024 and assigned a PDUFA date of August 10, 2024.

The company specified that FDA did not disclose a new PDUFA date.

"FDA leadership noted that Humacyte's ATEV is a first-in-class product, and that Priority Review had been granted, which allows only a six-month review cycle, as compared to the standard ten-month review cycle for most products", said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte.

"During the course of the BLA review, the FDA has conducted inspections of our manufacturing facilities and clinical sites and has actively engaged with us in multiple discussions regarding our BLA filing, including post-marketing and labeling discussions. Based on these interactions, we are confident in the approvability of the ATEV in treating vascular trauma", she added.

HUMA stock had closed at $7.91, down 1.13 percent on Friday. In after-hours, the shares further declined 10.38% to $7.09.