Shares of Humacyte, a clinical-stage biotechnology company, surged after receiving priority review from the U.S. Food and Drug Administration (FDA) for its vascular trauma treatment. The stock experienced an almost 13% increase, reaching $3.53 on Friday. Over the past year, shares have risen by 21%.

Humacyte’s biologics license application, focusing on its Human Acellular Vessel (HAV) technology, intends to provide urgent arterial repair for cases where synthetic grafts or autologous veins are not feasible. The FDA accepted and expedited the application, moving the review process forward.

Laura Niklason, Chief Executive of Humacyte, expressed excitement regarding the progress: “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. 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.”

The action date for Humacyte’s BLA has been set for August 10, with priority review shortening the wait time to six months instead of the usual 10 months.

HAV, a bioengineered tissue, is being investigated as a universally implantable vascular replacement that eliminates the need for immune suppression and reduces the risk of infection post-implantation.

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