The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the North Carolina Middle District on behalf of those who acquired Humacyte, Inc. (“Humacyte” or the “Company”) (NASDAQ: HUMA) securities during the period of May 10, 2024 to October 17, 2024, inclusive (“the Class Period”). Investors have until January 17, 2025 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

[Click here to learn more about the class action]

On August 9, 2024, after market hours, Humacyte disclosed that the FDA needed additional time to complete its review of its Biologic License Application (BLA) for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication, stating that the FDA had conducted inspections of the Company’s manufacturing facilities and clinical sites and has actively engaged with the Company in multiple discussions regarding its BLA filing. On this news, the price of Humacyte’s shared declined by $1.29, or 16.4%, from $7.91 on August 9, 2024, to close at $6.62 per share on August 12, 2024.

Then, on October 17, 2024, the FDA revealed that it had identified several violations at Humacyte’s North Carolina facility, including no microbial quality assurance and no microbial testing, and that quality oversight is inadequate. On this news, the price of Humacyte’s shares declined by $0.95 per share or 16.4%, from $5.81 on October 16, 2024, to close at $4.86 per share on October 17, 2024.

The lawsuit alleges that Humacyte misled investors by failing to disclose significant manufacturing deficiencies at its Durham, North Carolina facility. The defendants did not inform investors about issues such as inadequate quality assurance and the absence of microbial testing, which were identified by the FDA during inspections. These undisclosed problems led to delays in the FDA's review of Humacyte's BLA for their ATEV intended for vascular trauma treatment. As a result, investors contend that they were misled about the company's compliance with regulatory standards and the approval prospects of its product, leading to financial losses when these issues came to light.

If you purchased or otherwise acquired Humacyte securities, have information, or would like to learn more about this investigation, please contact Thomas W. Elrod of Kirby McInerney LLP by email at investigations@kmllp.com, or by filling out this CONTACT FORM, to discuss your rights or interests with respect to these matters without any cost to you.

Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm’s efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found at Kirby McInerney LLP’s website.

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