Humacyte gains after US FDA grants priority review for blood vessel replacement implant

Humacyte

09/02/2024 14:30

** Shares of Humacyte  HUMA.O  rise ~5% to $3.29 premarket 
    ** HUMA says the U.S. Food and Drug Administration (FDA) has
accepted the application seeking approval for its experimental
blood vessel substitute under priority review for patients who
have suffered vascular trauma    
    ** Co's human acellular vessel (HAV) is a bioengineered
human tissue being developed as an implantable vascular
replacement that does not require immune suppression and that
resists infection after implantation -HUMA
    ** FDA will announce a decision on HAV by Aug. 10
    ** HUMA says the marketing application is based on data from
a mid-late stage study and outcomes of real-world use of HAV
under a humanitarian aid program to treat wartime trauma
injuries in Ukraine
    ** Priority review applications have a six-month review time
instead of ten months for a standard review
    ** Up to last close, stock down ~2% in the last 12 months

 (Reporting by Mariam Sunny in Bengaluru)
 ((Mariam.ESunny@thomsonreuters.com;))