The law firm of Kirby McInerney LLP is investigating potential claims against Humacyte, Inc. (“Humacyte” or the “Company”) (NASDAQ: HUMA). The investigation concerns whether Humacyte and/or certain of its officers have violated the federal securities laws and/or engaged in other unlawful business practices.

[Click here to learn more about the investigation]

On August 9, 2024, Humacyte disclosed that the U.S. Food and Drug Administration (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 shares declined by $1.30, or approximately 16.3%, from $7.91 on August 9, 2024, to close at $6.61 per share on August 12, 2024.

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 shares declined by $0.95 per share, or approximately 16.4%, from $5.81 per share on October 16, 2024, to close at $4.86 per share on October 17, 2024.

If you purchased or otherwise acquired Humacyte securities, have information, or would like to learn more about this investigation, 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.

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