“During 2023, we accomplished major goals across all of our clinical programs. In December 2023, we submitted our Biologics License Application to the Food and Drug Administration seeking approval of the HAV in the vascular trauma indication,” said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte. “The FDA’s acceptance of our filing in February 2024 brings us another major step closer to our goal of providing an innovative regenerative medicine product for patients suffering traumatic vascular injury. We believe the FDA’s decision to grant Priority Review reflects their recognition that many patients with severe injuries are underserved by the current standard of care. We look forward to working with the agency toward their Prescription Drug User Fee Act date of August 10, 2024.”
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