Human Acellular Vessel™ (HAV™) Biologics License Application Granted Priority Review by U.S. FDA for the Treatment of Vascular Trauma
Humacyte, Inc. (HUMA)
Company Research
Source: GlobeNewswire
– BLA submission supported by results from Phase 2/3 clinical trial and outcomes of real-world use of the HAV under a Humanitarian Aid Program to treat wartime trauma injuries in Ukraine – – The HAV had higher rates of patency, and lower rates of amputation and infection, compared to historic synthetic graft benchmarks – – PDUFA date set for August 10, 2024 – DURHAM, N.C., Feb. 09, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to Humacyte’s Biologics License Application (BLA) seeking approval of the Human Acellular Vessel (HAV) in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible. The Prescription Drug User Fee Act (PDUFA) date, the FDA action
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HUMA
Earnings
- 3/22/24 - Beat
HUMA
Sec Filings
- 3/28/24 - Form S-8
- 3/28/24 - Form 10-K
- 3/22/24 - Form 8-K
- HUMA's page on the SEC website