Robbins LLP is Investigating Allegations that Humacyte, Inc (HUMA) Misled Investors Regarding its Manufacturing Practices

Robbins LLP announces that a shareholder filed a class action on behalf of all persons and entities that purchased or otherwise acquired Humacyte, Inc. (NASDAQ: HUMA) securities between May 10, 2024 and October 17, 2024. Humacyte and its consolidated subsidiaries develop and manufacture off-the-shelf, implantable, and bioengineered human tissues.

The Allegations

According to the complaint, Humacyte 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. On August 9, 2024, Humacyte issued a press release announcing that the 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.” The press release disclosed in part, 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[.]” On this news, the Company’s stock price declined $1.29, or 16.4%, to close at $6.62 per share on August 12, 2024. The complaint further alleges that on October 17, 2024, the FDA released a Form 483 concerning Humacyte’s Durham, North Carolina facility, which revealed violations, including “no microbial quality assurance,” “no microbial testing,” and inadequate “quality oversight.” On this news, the Company’s stock price declined $0.95, or 16.35%, to close at $4.86 per share on October 17, 2024.

Plaintiff alleges that during the class period, defendants failed to disclose to investors: (1) that the Company’s Durham, North Carolina facility failed to comply with good manufacturing practices, including quality assurance and microbial testing; (2) that the FDA’s review of the BLA would be delayed while Humacyte remediated these deficiencies; and (3) that, as a result, there was a substantial risk to FDA approval of ATEV for vascular trauma.

What Now: You may be eligible to participate in the class action against Humacyte, Inc. Shareholders who want to serve as lead plaintiff for the class must submit their application to the court by January 17, 2025. A lead plaintiff is a representative party who acts on behalf of other class members in directing the litigation.  You do not have to participate in the case to be eligible for a recovery. If you choose to take no action, you can remain an absent class member.

All representation is on a contingency fee basis. Shareholders pay no fees or expenses.