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HUMA.US
id: 1397

Humacyte (HUMA) FDA Approval Delays Case

M.D. North Carolina
Court
1:24-cv-00954
Case number
05/10/2024
Class period Start
10/17/2024
Class period End
01/18/2025
Lead Plaintiff motion deadline
  • $HUMA stockholders filed a claim against Humacyte for misleading them about the chances of timely approval for its flagship product.
  • Following disclosures of FDA delays, $HUMA dropped by 16.4% on August 12, 2024, and another 16.35% on October 17, 2024.
  • Humacyte investors can join this case to seek compensation for financial losses.
Case Details:

Between May 10, 2024, and October 17, 2024, Humacyte assured investors that its BLA for its Acellular Tissue Engineered Vessel (ATEV) was on track for FDA approval.

However, on August 9, 2024, Humacyte revealed that the FDA required more time to complete its review due to inspections revealing significant manufacturing deficiencies, including inadequate microbial quality assurance and testing.

On October 17, 2024, the FDA released a Form 483 highlighting these issues and detailing failures in compliance with good manufacturing practices at Humacyte’s Durham, North Carolina facility.

These revelations cast serious doubt on the company's ability to secure FDA approval for its ATEV product, causing $HUMA to drop 16.35%.

Based on these events, $HUMA investors filed a claim against Humacyte, accusing the company of the following:
  • It failed to disclose deficiencies in its manufacturing processes, including quality assurance and microbial testing.
  • It misled investors about the risks of delays in FDA approval for its ATEV product.
Investors believe that Humacyte failed to disclose manufacturing deficiencies and delays in FDA approval for its ATEV product.
Case Status
Lead Plaintiff Submission
Alleged Offence
Misleading Statements, 
Failure to Disclose
Suspected Party
Directors, 
Management
Security Type
Stocks
Trade Direction
Long
Shock Event Date
08/09/2024
Filing date
11/18/2024
Lead Plaintiff Deadline
01/18/2025
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