By Kailyn Rhone
Shares of Humacyte rose after the U.S. Food and Drug Administration granted priority review to its vascular trauma treatment in development.
The stock was up almost 13% to $3.53 on Friday. Shares are up 21% in the past 12 months.
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.
“The BLA acceptance brings us a major step closer to our goal of providing an innovative regenerative medicine product for patients suffering traumatic vascular injury,” Chief Executive Laura Niklason said. “Many patients with severe injuries are underserved by the current standard of care, and we are proud of the results that have been seen in our clinical trials and real-world humanitarian efforts.”
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.
Write to Kailyn Rhone at [email protected]
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