Humacyte, Inc.
Case Overview
28 Days Left to Seek Lead Plaintiff
Lead Plaintiff Deadline: | Lead Plaintiff Deadline: 01/17/2025 |
Status: | Status: Investigating |
Company Name: | Company Name: Humacyte, Inc. |
Court: | Court: Middle District of North Carolina |
Case Number: | Case Number: 1:24cv00954 |
Class Period: | Class Period: 05/10/2024 - 10/17/2024 |
Ticker: | Ticker: HUMA |
Related Attorneys: | Lead Attorneys: Thomas W. Elrod |
Related Practices: | Related Practices: Securities |
On August 9, 2024, after market hours, Humacyte disclosed that the 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 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’s shares declined by $1.29, or approximately 16.4%, from $7.91 on August 9, 2024, to close at $6.62 per share on August 12, 2024.
Then, on October 17, 2024, the FDA revealed that it had identified several violations at Humacyte’s North Carolina facility, including no microbial quality assurance ortesting, and inadequate quality oversight. On this news, the price of Humacyte’s shares declined by $0.95 per share or approximately 16.4%, from $5.81 on October 16, 2024, to close at $4.86 per share on October 17, 2024.
The lawsuit alleges that Humacyte misled investors by failing to disclose significant manufacturing deficiencies at its Durham, North Carolina facility. The defendants did not inform investors about issues such as inadequate quality assurance and the absence of microbial testing, which were identified by the FDA during inspections. These undisclosed problems led to delays in the FDA’s review of Humacyte’s BLA for their ATEV intended for vascular trauma treatment.
Then, on October 17, 2024, the FDA revealed that it had identified several violations at Humacyte’s North Carolina facility, including no microbial quality assurance ortesting, and inadequate quality oversight. On this news, the price of Humacyte’s shares declined by $0.95 per share or approximately 16.4%, from $5.81 on October 16, 2024, to close at $4.86 per share on October 17, 2024.
The lawsuit alleges that Humacyte misled investors by failing to disclose significant manufacturing deficiencies at its Durham, North Carolina facility. The defendants did not inform investors about issues such as inadequate quality assurance and the absence of microbial testing, which were identified by the FDA during inspections. These undisclosed problems led to delays in the FDA’s review of Humacyte’s BLA for their ATEV intended for vascular trauma treatment.