A securities class action has been filed in the USDC — M.D.N.C. against Humacyte, Inc. (HUMA) (“Humacyte” or the “Company”), on behalf of all persons or entities that purchased or otherwise acquired Humacyte securities between May 10, 2024 and October 17, 2024, both dates inclusive (the “Class Period”).
Humacyte and its consolidated subsidiaries engage in the development and manufacture of off-the-shelf, implantable, and bioengineered human tissues. The Company is currently engaged in engineering and manufacturing Acellular Tissue Engineered Vessel (“ATEV”), also known as “Human Acellular Vessel,” which is a lab-grown blood vessel implant that can act as a replacement for an injured or damaged blood vessel.
The claim arises on October 17, 2024, during market hours, when the FDA released a Form 483 concerning Humacyte’s Durham, North Carolina facility, which revealed a number of violations, including “no microbial quality assurance,” “no microbial testing,” and inadequate “quality oversight.”
The complaint alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors:
(1) that the Company’s Durham, North Carolina facility failed to comply with good manufacturing practices, including quality assurance and microbial testing;
(2) that the FDA’s review of the BLA would be delayed while Humacyte remediated these deficiencies; and
(3) that, as a result, there was a substantial risk to FDA approval of ATEV for vascular trauma; and
(4) that, as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis, thereby harming investors.
On this news, the Company’s stock price declined $0.95, or 16.35%, to close at $4.86 per share on October 17, 2024, on unusually heavy volume.
If you purchased Humacyte securities during the class period and would like to receive more information or join the action, please enter your contact information below for a FREE consultation and click “Submit Your Information.”
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