Humacyte, Inc. Investors: Please contact the Portnoy Law Firm to recover your losses. January 17, 2025 Deadline to file Lead Plaintiff Motion
Investors can contact the law firm at no cost to learn more about recovering their losses
LOS ANGELES, Jan. 10, 2025 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Humacyte, Inc. ("Humacyte" or the "Company") (NASDAQ: HUMA) investors of a class action representing investors that bought securities between May 10, 2024 and October 17, 2024, inclusive (the "Class Period"). Humacyte investors have until January 17, 2025 to file a lead plaintiff motion.
Investors are encouraged to contact attorney Lesley F. Portnoy, by phone 310-692-8883 or email: lesley@portnoylaw.com, to discuss their legal rights, or click here to join the case. The Portnoy Law Firm can provide a complimentary case evaluation and discuss investors’ options for pursuing claims to recover their losses.
Case Allegations: Humacyte is involved in developing and manufacturing bioengineered, off-the-shelf human tissues designed for implantation, aiming to treat various diseases and conditions across different parts of the body. The company is currently working on Acellular Tissue Engineered Vessel (ATEV) and, in December 2023, submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its use in urgent arterial repair following vascular trauma, especially when synthetic grafts or autologous veins are not viable options.
The class action lawsuit against Humacyte claims that, during the relevant period, the company made false or misleading statements, and failed to disclose critical information, including:
- Humacyte’s Durham, North Carolina manufacturing facility did not meet good manufacturing practices (GMP), including failing in quality assurance and microbial testing.
- The FDA’s review of the BLA would be delayed due to these issues, which would pose a significant risk to receiving FDA approval for ATEV as a treatment for vascular trauma.
Additionally, the lawsuit claims that on August 9, 2024, Humacyte revealed that the FDA would need more time to complete its review of the BLA for ATEV in vascular trauma. The company also disclosed that the FDA had inspected their manufacturing facilities and clinical sites, engaging in discussions about the BLA filing. Following this announcement, Humacyte’s stock price dropped by more than 16%, according to the complaint.
On October 17, 2024, the lawsuit further claims that the FDA issued a Form 483, which highlighted several violations at Humacyte’s Durham facility, including a lack of microbial quality assurance, no microbial testing, and insufficient quality oversight. This news caused Humacyte’s stock price to fall by an additional 16.35%.
Please visit our website to review more information and submit your transaction information.
The Portnoy Law Firm represents investors in pursuing claims against caused by corporate wrongdoing. The Firm’s founding partner has recovered over $5.5 billion for aggrieved investors. Attorney advertising. Prior results do not guarantee similar outcomes.
Lesley F. Portnoy, Esq.
Admitted CA and NY Bar
lesley@portnoylaw.com
310-692-8883
www.portnoylaw.com
Attorney Advertising
Legal Disclaimer:
EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
