FX.co ★ Humacyte: FDA Extends Time To Review ATEV For Vascular Trauma Indication

Humacyte, Inc. (HUMA) experienced a significant decline in after-hours trading on Friday, with shares dropping over 10%. This came after the Food and Drug Administration (FDA) announced it needs additional time to assess the acellular tissue-engineered vessel (ATEV) for vascular trauma.

Humacyte had initially submitted a Biologics License Application (BLA) for the ATEV trauma program in December 2023. The FDA granted Priority Review in February 2024, setting a Prescription Drug User Fee Act (PDUFA) target date of August 10, 2024. However, the FDA has not yet provided a new PDUFA date.

"FDA leadership acknowledged that Humacyte's ATEV is a pioneering product and had been given a Priority Review, which entails a six-month review period instead of the standard ten-month period," stated Laura Niklason, M.D., Ph.D., the Chief Executive Officer of Humacyte.

"During the BLA review process, the FDA has conducted thorough inspections of our manufacturing facilities and clinical sites. We have engaged in numerous discussions about our BLA filing, including post-marketing and labeling considerations. Based on these interactions, we are optimistic about the ATEV's potential approval for treating vascular trauma," she added.

On Friday, HUMA shares closed at $7.91, marking a 1.13% decrease. In after-hours trading, the stock further plummeted by 10.38% to $7.09.