Humacyte, Inc.
Company Name | Humacyte, Inc. |
Stock Symbol | HUMA |
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 had 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, Humacyte’s stock price fell $1.29, or 16.4%, to close at $6.62 per share on August 12, 2024, thereby injuring investors.
Then, on October 17, 2024, the FDA revealed that it had identified a number of violations at Humacyte’s North Carolina facility, including “no microbial quality assurance” and “no microbial testing,” and “that quality oversight is inadequate.”
On this news, Humacyte’s stock price fell $0.95, or 16.4%, to close at $4.86 per share on October 17, 2024, thereby injuring investors further.
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