Overview

A class action lawsuit has been filed against Humacyte, Inc. (“Humacyte” or the “Company”) (NASDAQ: HUMA) and certain of the Company’s former senior executive officers alleging violations of the federal securities laws. The Humacyte class action lawsuit is brought on behalf of all persons and entities who purchased or otherwise acquired Humacyte securities between May 10, 2024, and October 17, 2024, both dates inclusive (the “Class Period”).  Investors have until January 17, 2025, to seek appointment as lead plaintiff in the Humacyte class action lawsuit.

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 Company has not generated revenue from the sale of any products to date.

In December 2023, the Company filed a Biologics License Application (“BLA”) with the U.S. Food and Drug Administration (“FDA”) to use ATEV in urgent arterial repair following extremity vascular trauma when it is not feasible to use a synthetic graft or autologous vein.  In February 2024, the FDA granted Priority Review with a Prescription Drug User Fee Act date of August 10, 2024.

The Humacyte class action lawsuit alleges that Defendants, throughout the Class Period, made materially false and/or misleading statements, as well as failed to disclose material adverse facts, about the Company’s business and operations.  Specifically, Defendants misrepresented and/or failed to disclose that: (1) the Company’s Durham, North Carolina facility failed to comply with good manufacturing practices, including quality assurance and microbial testing; that the FDA’s review of the BLA would be delayed while Humacyte remediated these deficiencies; (3) as a result, there was a substantial risk to FDA approval of ATEV for vascular trauma; and (4) 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.

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If you purchased or otherwise acquired Humacyte securities between May 10, 2024, and October 17, 2024, both dates inclusive, and you wish to serve as lead plaintiff in this lawsuit, we encourage you to submit your information to DiCello Levitt LLP via the form on this page. 

You can also contact DiCello Levitt partner Brian O’Mara by calling (888) 287-9005 or at [email protected]. 

The deadline to apply to the Court to serve as a lead plaintiff in the Humacyte class action lawsuit is January 17, 2025.