Sign In
Step 1
Unite with Fellow Investors
Step 2
Choose the Best Attorney
Step 3
Provide Documents
Step 4
Follow Case Progress
Step 5
Get Payout
HUMA.US
id: 1397

Humacyte (HUMA) FDA Approval Delays Case

The court has appointed the lead plaintiff to represent the class.
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 Appointed
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

Humacyte Inc

Humacyte, Inc., together with its subsidiaries, engages in the development and manufacture of off-the-shelf, implantable, and bioengineered human tissues for the treatment of diseases and condition...

    Ticker
    HUMA.US
    ISIN
    US44486Q1031
    CIK
    0001818382
    Sector
    Healthcare
    Industry
    Biotechnology
    Country
    USA
    Address
    2525 East North Carolina Highway 54, Durham, NC, United States, 27713