Humacyte, Inc. Class Action Lawsuit
Case Summary
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The Humacyte class action lawsuit seeks to represent purchasers or acquirers of Humacyte, Inc. (NASDAQ: HUMA) securities between May 10, 2024 and October 17, 2024, inclusive (the “Class Period”). Captioned Cutshall v. Humacyte, Inc., No. 24-cv-00954 (M.D.N.C.), the Humacyte class action lawsuit charges Humacyte and certain of Humacyte’s top executives with violations of the Securities Exchange Act of 1934.
If you suffered substantial losses and wish to serve as lead plaintiff of the Humacyte class action lawsuit, please provide your information in the form on this page. You can also contact attorney J.C. Sanchez or Jennifer N. Caringal of Robbins Geller by calling 800/449-4900 or via e-mail at info@rgrdlaw.com. Lead plaintiff motions for the Humacyte class action lawsuit must be filed with the court no later than January 17, 2025.
CASE ALLEGATIONS: Humacyte engages in the development and manufacture of off-the-shelf, implantable, and bioengineered human tissues for the treatment of diseases and conditions across a range of anatomic locations in multiple therapeutic areas. According to the complaint, Humacyte is currently engaged in engineering and manufacturing Acellular Tissue Engineered Vessel (“ATEV”), and in December 2023, Humacyte filed a Biologics License Application (“BLA”) with the U.S. Food and Drug Administration (“FDA”) to use ATEV in urgent arterial repair following extremity vascular trauma and it is not feasible to use a synthetic graft or autologous vein.
The Humacyte class action lawsuit alleges that defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (i) Humacyte’s Durham, North Carolina facility failed to comply with good manufacturing practices, including quality assurance and microbial testing; (ii) the FDA’s review of the BLA would be delayed while Humacyte remediated these deficiencies; and (iii) as a result, there was a substantial risk to FDA approval of ATEV for vascular trauma.
The Humacyte class action lawsuit further alleges that on August 9, 2024, Humacyte announced 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,” and further disclosed 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 price of Humacyte stock fell more than 16%, according to the complaint.
Then, on October 17, 2024, the Humacyte class action lawsuit further alleges that the FDA released 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.” The complaint alleges that on this news, the price of Humacyte stock fell an additional 16.35%.
THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased or acquired Humacyte securities during the Class Period to seek appointment as lead plaintiff in the Humacyte class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the Humacyte class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the Humacyte class action lawsuit. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff of the Humacyte class action lawsuit.
ABOUT ROBBINS GELLER: Robbins Geller Rudman & Dowd LLP is one of the world’s leading law firms representing investors in securities fraud cases. Our Firm has been #1 in the ISS Securities Class Action Services rankings for six out of the last ten years for securing the most monetary relief for investors. We recovered $6.6 billion for investors in securities-related class action cases – over $2.2 billion more than any other law firm in the last four years. With 200 lawyers in 10 offices, Robbins Geller is one of the largest plaintiffs’ firms in the world and the Firm’s attorneys have obtained many of the largest securities class action recoveries in history, including the largest securities class action recovery ever – $7.2 billion – in In re Enron Corp. Sec. Litig.