Human Acellular Vessel™ (HAV™) Biologics License Application Granted Priority Review by U.S. FDA for the Treatment of Vascular Trauma [Yahoo! Finance]
Humacyte, Inc. (HUMA)
Company Research
Source: Yahoo! Finance
– 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 date for their regulatory decision regarding the BLA, is August 10, 2024. This targeted PDUFA date is based on the Priority Review grant, which is a mechanism reserved by FDA for products
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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