Humacyte, Inc. (NasdaqGS: HUMA)

Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (“KSF”), announces that KSF has commenced an investigation into Humacyte, Inc. (NasdaqGS: HUMA) (“Humacyte” or the “Company”).

On August 9, 2024, the company announced that the 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,” disclosing that “[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[.]” Then, on October 17, 2024, the FDA issued 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.”

Thereafter, the Company and certain of its executives were sued in a securities class action lawsuit, charging them with failing to disclose material information during the Class Period in violation of federal securities laws, which remains ongoing.

KSF’s investigation is focusing on whether Humacyte’s officers and/or directors breached their fiduciary duties to its shareholders or otherwise violated state or federal laws.

If you have information that would assist KSF in its investigation, or have been a long-term holder of Humacyte shares and would like to discuss your legal rights, you may, without obligation or cost to you, call toll-free at 1-833-938-0905 or email KSF Managing Partner Lewis Kahn (lewis.kahn@ksfcounsel.com), or fill out the form on this page.