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ALVO.US
id: 931, Created by , Scout

Alvotech (ALVO) FDA Approval Delay Case

  • In Apr. Alvotech disclosed the delay of FDA approval of its biosimilar AVT02 until the resolution of manufacturing deficiencies.
  • On it, $ALVO fell 22.1%, losing $800M+ of shareholder value.
  • Investors may have grounds to suspect Alvotech of failing to timely disclose and resolve manufacturing deficiencies, which led to their losses.
On April 13, 2023, Alvotech (ALVO) disclosed that it received communication from the FDA regarding its March 2022 inspection of Alvotech’s manufacturing facility in Reykjavik, Iceland.
  • FDA noted deficiencies related to the Reykjavik facility.
  • FDA stated that a satisfactory resolution of the deficiencies is required before the FDA can approve the Company’s Biologics License Application (BLA) for AVT02.
On this news, $ALVO fell 22.1% and lost over $806 million of its market capitalization, seriously damaging shareholders.

Considering all the facts, Investors may have grounds to suspect Alvotech of failing to timely disclose and resolve manufacturing deficiencies, 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
14 April 2023
Collecting participants…

Alvotech

Alvotech, through its subsidiaries, develops and manufactures biosimilar medicines for patients worldwide. It offers biosimilar products in the therapeutic areas of autoimmune, eye, and bone disord...

    Ticker
    ALVO.US
    ISIN
    LU2458332611
    CIK
    1898416
    Sector
    Healthcare
    Industry
    Drug Manufacturers - Specialty & Generic
    Country
    USA
    Address
    Saemundargata 15-19, Reykjavik, Iceland, 102