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MDXG.US
id: 1057, Created by , Scout

MiMedx Group (MDXG) FDA Inspection and Warning Letter Case

  • On December 29, 2023, MiMedx (MDXG) issued a press release announcing that FDA reclassified one of its recently-launched products for a different type of enforcement. Despite Company’s objections, on December 21, 2023, Warning Letter from FDA reiterated the agency’s position.
  • On it, on January 2, 2024, $MDXG fell 10.26%, losing $131M+ of shareholder value.
  • Investors may have grounds to suspect MiMedx Group of regulatory setbacks, which led to their losses.
On December 29, 2023, MiMedx issued a press release announcing that following an inspection, the FDA took the position that one of the Company’s recently-launched placental-derived tissue products – AXIOFILL – does not meet the requirements as a Section 361 product and is therefore subject to enforcement as a Section 351 product. Specifically, FDA asserts that the production of AXIOFILL involves more than “minimal manipulation.”

The Company did not agree with FDA’s position and has been actively engaged with the agency through its “Request For Designation” process. However, on December 21, 2023, MIMEDX received a Warning Letter from FDA reiterating the agency’s position on AXIOFILL.

On this news, on January 2, 2024, $MDXG fell 11.13% and lost over $131 million of its market capitalization, seriously damaging shareholders.

Considering all the information, investors might have grounds to suspect MiMedx Group of failing to comply with federal regulations, which led to their losses.

The case is already under investigation by at least one of the reputable law firms.
Alleged Offence
Misleading Statements
Failure to Disclose
Omissions
Suspected Party
Directors
Management
Security Type
Stocks
Trade Direction
Long
Shock Event Date
02 January 2024
Collecting participants…

MiMedx Group Inc

MiMedx Group, Inc. develops and distributes placental tissue allografts for various sectors of healthcare. It processes the human placental tissues utilizing its patented and proprietary PURION pro...

    Ticker
    MDXG.US
    ISIN
    US6024961012
    CIK
    1376339
    Sector
    Healthcare
    Industry
    Biotechnology
    Country
    USA
    Address
    1775 West Oak Commons Court, NE, Marietta, GA, United States, 30062