Humacyte Shares Rise 8% After Completing Enrollment in Phase 2/3 Trial
31 Juillet 2023 - 7:28PM
Dow Jones News
By Chris Wack
Humacyte shares were up 8% to $3.23 after the company completed
enrollment of its Phase 2/3 vascular trauma trial that is expected
to support a Biologics License Application filing for its Human
Acellular Vessel in vascular trauma repair.
The stock hit its 52-week high of $5.60 on May 8, and is down 7%
in the past 12 months.
The HAV is Humacyte's regenerative medicine product candidate,
designed to provide surgeons with an off-the-shelf bioengineered
human artery that has been observed to repopulate with the
patient's own cells to provide a durable, infection-resistant
replacement for damaged and diseased arteries.
The results from the Phase 2/3 vascular trauma trial are
intended to support a BLA filing with the U.S. Food and Drug
Administration planned for the fourth quarter.
The trial is a single-arm, open-label, pivotal study of patients
suffering from vascular trauma injuries, conducted at Level 1
Trauma Centers in the U.S. and Israel. The company expects to
complete these activities and report top-line results from the
trial before the end of the third quarter.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
July 31, 2023 13:13 ET (17:13 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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