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Kaplan Fox & Kilsheimer LLP is Investigating Humacyte, Inc. (HUMA) for Potential Securities Law Violations

NEW YORK - (NewMediaWire) - October 22, 2024 - Kaplan Fox & Kilsheimer LLP is investigating potential securities violations against Humacyte, Inc. (“Humacyte” or the “Company”) (NASDAQ: HUMA).

CLICK HERE TO RECEIVE MORE INFORMATION ABOUT THIS INVESTIGATION

If you are a Humacyte investor and have suffered losses, you may CLICK HERE to contact us. You may also contact Kaplan Fox by emailing pmayer@kaplanfox.com or by calling (646) 315-9003.

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.

WHY CONTACT KAPLAN FOX - Kaplan Fox is a leading national law firm focusing on complex litigation with offices in New York, Oakland, Los Angeles, Chicago and New Jersey.  With over 50 years of experience in securities litigation, Kaplan Fox offers the professional experience and track record that clients demand.  Through prosecuting cases on the federal and state levels, Kaplan Fox has successfully shaped the law through winning many important decisions on behalf of our clients.  For more information about Kaplan Fox & Kilsheimer LLP, you may visit our website at www.kaplanfox.com.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

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

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