Hagens Berman's Investigation into Alvotech Following FDA's Sever Blow to Stock

Investigation into Alvotech (ALVO) Hagens Berman, a national firm focused on shareholder rights, has initiated an investigation into Alvotech (NASDAQ: ALVO). This scrutiny arises from a significant stock decline following a disappointing announcement regarding the company's lead biosimilar candidate, AVT05. The plunge, which saw Alvotech's stock drop by 34% in a single day, has drawn the attention of investors concerned about potential securities fraud. ## Background on the Stock Drop On November 2, 2025, Alvotech revealed that the FDA issued a Complete Response Letter (CRL) regarding AVT05. This communication indicated that the application for FDA approval would not be granted in its current form due to "certain deficiencies" discovered during an inspection of Alvotech's manufacturing facility in Reykjavik, Iceland, conducted in July 2025. The shockingly negative news led the company to dramatically revise its 2025 financial projections, slashing its revenue outlook and causing its market capitalization to shrink significantly. Prior to this, Alvotech had been optimistic about the commercial prospects of AVT05, even projecting revenues as high as $700 million for the year. Alvotech's management had repeatedly touted the readiness of their production facility to meet FDA standards, raising questions about their disclosures. It’s alleged that they might have misled investors regarding the state of their manufacturing operations. ## Investigation Focus The Hagens Berman investigation centers on whether Alvotech misrepresented aspects of its manufacturing abilities and the likelihood of receiving FDA approval for its biosimilar products. They are examining if there was any indication that Alvotech leadership was aware of manufacturing challenges leading up to the FDA's abrupt communication. "We are looking into whether Alvotech was aware of these significant manufacturing failures months before they admitted them to the public," stated Reed Kathrein, the Hagens Berman partner leading the investigation. ## Implications for Investors Investors who purchased Alvotech securities and faced substantial losses due to the recent stock crash are encouraged to reach out to Hagens Berman for support and further information. Those who may possess non-public information related to Alvotech's operations or internal communications with the FDA are also urged to step forward, as their insights could be invaluable to the ongoing investigation. Hagens Berman has emphasized its commitment to holding corporations accountable for potential securities fraud and safeguarding the rights of shareholders. The firm has a rich history of advocating for investors and has secured over $2.9 billion in recoveries in various cases linked to corporate misconduct. ## FAQs Regarding the Investigation 1. Why is Hagens Berman investigating Alvotech? The firm is assessing whether Alvotech disseminated misleading statements about its manufacturing capabilities and the potential for FDA approval of its biosimilar products. 2. What is a Complete Response Letter (CRL) and how did it affect Alvotech? A Complete Response Letter signifies that the FDA has not approved an application due to various deficiencies, which, in Alvotech's case, led to an unexpected decrease in revenue projections and marked impacts on the company's stock prices. 3. How can I assist the Alvotech investigation? Individuals with non-public insights regarding Alvotech’s operational state, or internal deliberations related to the FDA, are invited to connect with Hagens Berman. Hagens Berman is poised to keep the public informed as this investigation progresses and advocates for any impacted investors seeking rightful restitution.