Grandbrothers
Humacyte (NASDAQ:HUMA) stock fell 18% in after-hours trading Friday after the company said the FDA has informed the company that it will need additional time to complete its review of the Biologics License Application for the acellular tissue engineered vessel, or ATEV, for the treatment of vascular trauma.
The company said the agency apologized for the delay and has not yet issued a revised action date. The agency was originally expected to issue a decision on the application by Aug. 10.
Humacyte said that based on its interaction with the FDA, it is confident about the approvability of the product for the vascular trauma indication.
The company added that it plans to hold its Q2 conference call on the morning of Aug. 13.
(Updates stock movement, corrects original action date.)
#Humacyte #stock #falls #FDA #delay #ATEV #NASDAQHUMA
