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.