NEW YORK, NY - 
(NewMediaWire) - October 19, 2024 - Kaplan Fox & Kilsheimer LLP is investigating potential securities violations against Humacyte, Inc. (“Humacyte” or the “Company”) (NASDAQ: HUMA).
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On August 9, 2024, after the market closed, Humacyte issued a press release announcing that “the U.S. Food and Drug Administration (FDA) will require additional time to complete its review of its Biologic License Application (BLA) for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication.” The press release also states “[d]uring the course of the BLA review, the FDA has conducted inspections of our manufacturing facilities and clinical sites and has actively engaged with us in multiple discussions regarding our BLA filing. . . .”
On August 12, 2024, the first trading day following the news, the price of Humacyte shares fell by $1.295 per share, more than 16%, to close at $6.615 per share.
Then, on October 17, 2024, the FDA disclosed in a Form 483 that a number of violations were found at Humacyte’s Durham, North Carolina facility during an inspection performed by the FDA on April 1 through April 5, 2024. The violations cited by the FDA include, among other things, references to “no microbial quality assurance.” “no microbial testing,” and “inadequate” quality oversight at the facility for a number of issues.
On this news, the price of Humacyte shares fell $0.95 per share, more than 16%, to close at $4.86 per share on October 17,2024, the first trading day following the news.
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If you have any questions about this investigation, please contact:
Pamela A. Mayer
KAPLAN FOX & KILSHEIMER LLP
800 Third Avenue, 38th Floor
New York, New York 10022
(646) 315-9003
pmayer@kaplanfox.com
Laurence D. King
KAPLAN FOX & KILSHEIMER LLP
1999 Harrison Street, Suite 1560
Oakland, California 94612
(415) 772-4704
lking@kaplanfox.com
