By Kailyn RhoneShares of Humacyte rose after the U.S. Food and Drug Administration granted priority review to its vascular trauma treatment in development. The clinical-stage biotechnology company on Friday said the FDA accepted and expedited its biologics license application seeking approval for its Human Acellular Vessel technology for urgent arterial repair following vascular trauma, when neither synthetic graft nor autologous vein use is feasible. FDA will set its action date for the Hymacyte's BLA for Aug. 10. Priority review pushed the review date forward to a six-month wait time rather than the standard 10 months. HAV, a bioengineered tissue, is under investigation as a universally implantable vascular replacement that does not require immune suppression and that resists infection after implantation.

Source: Wall Street Journal February 10, 2024 08:42 UTC