Class Action Lawsuit Filed Against Humacyte, Inc. Over SEC Violations

Kirby McInerney LLP has announced that a class action lawsuit is underway in the U.S. District Court for the North Carolina Middle District. This lawsuit represents investors who bought Humacyte, Inc. (“Humacyte” or the “Company”) HUMA securities between May 10, 2024, and October 17, 2024 (“the Class Period”). Interested investors have until January 17, 2025, to apply to the Court as lead plaintiff in this case.

[Click here to learn more about the class action]

On August 9, 2024, after markets closed, Humacyte shared that the FDA required more time to review its Biologic License Application (BLA) for their acellular tissue engineered vessel (ATEV) intended for vascular trauma. The FDA had inspected their manufacturing facilities and clinical sites, engaging in various discussions with Humacyte. Following this announcement, the company’s stock price fell by $1.29, or 16.4%, dropping from $7.91 on August 9, 2024, to close at $6.62 on August 12, 2024.

Later, on October 17, 2024, the FDA identified several regulatory issues at Humacyte’s North Carolina facility. Notably, the agency found inadequate microbial quality assurance and testing practices. The stock price felt the impact, declining by $0.95 per share, or another 16.4%, from $5.81 on October 16, 2024, to end at $4.86 per share on October 17, 2024.

The lawsuit claims that Humacyte misled investors by not revealing serious manufacturing deficiencies at its Durham facility. Investors were not informed about the lack of proper quality assurance and microbial testing revealed by FDA inspections. This lack of transparency allegedly affected FDA’s review timeline for Humacyte’s BLA for the ATEV, leading investors to believe the company adhered to regulatory standards. Consequently, when these issues surfaced, many experienced significant financial losses.

If you purchased or acquired Humacyte securities and have relevant information, or if you’re interested in learning more about this investigation, please reach out to Thomas W. Elrod of Kirby McInerney LLP via email at investigations@kmllp.com, or by completing this CONTACT FORM. There is no cost to discuss your rights regarding these matters.

Kirby McInerney LLP, located in New York, focuses on class actions in securities, antitrust, whistleblower claims, and consumer litigation. Their representation of shareholders in securities cases has led to recoveries totaling billions. More details about their services can be found on Kirby McInerney LLP’s official website.

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