Durham, North Carolina-based Humacyte Inc. (HUMA:NASDAQ) announced the submission of a Biologics License Application (BLA) to the FDA seeking approval for its lead product candidate Human Acellular Vessel (HAV)., noted H.C. Wainwright & Co. analyst Vernon Bernardino. Bernardino views this BLA filing as timely and keeping HAV on track for potential approval in late 2024.
The BLA is seeking approval of HAV for use in urgent arterial repair following extremity vascular trauma when synthetic grafts are unsuitable and autologous vein grafts are not feasible.
The company has requested Priority Review, which could accelerate approval to within six months of FDA acceptance versus ten months under Standard Review.
According to the analyst, HAV was granted priority designation in 2018 to expedite review, given its potential to address serious wartime injuries. This requires a semi-annual FDA review and suggests an upside to H.C. Wainwright's modeled 2024 approval.
BLA Backed by Positive Phase 2/3 Data
The BLA is supported by positive data from the Phase 2/3 V005 trial showing HAV had higher patency rates, lower infection rates, and reduced amputations versus synthetic graft benchmarks in vascular trauma patients.
Real-world HAV use in wartime injuries also backs the application.
Analyst Sets US$6 Price Target Based on $205M Peak Sales
H.C. Wainwright maintains a Buy rating on Humacyte with a US$6 price target implying over 120% upside. The valuation is based on modeled peak annual HAV sales of US$205 million in vascular trauma alone by 2031.
Additional pipeline indications like PAD and AV access represent added upside drivers.
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Disclosures for H.C. Wainwright & Co., Humacyte Inc., December 12, 2023
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I, Vernon Bernardino , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.
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