Alvotech (ALVO) Investigation

Skip to main content CASES Tipline 1-888-381-2889 Main navigation Cases Attorneys All Attorneys Steve W. Berman, Managing Partner Thomas M. Sobol, Executive Robert B. Carey, Executive France Team U.K. Team Newsroom Press Releases Blog Practices Anti-Terrorism Antitrust Litigation Automotive Litigation Child Sexual Abuse Civil & Human Rights Litigation Class Action Consumer Rights Data Breach, Privacy & Cybersecurity Emissions Litigation Employment Litigation Environmental Litigation First Responder Litigation Governmental Representation High Tech Litigation Intellectual Property Investor Fraud Personal Injury Litigation Pharmaceutical Fraud Sexual Abuse & Harassment Sports Litigation Veterans & Military Servicemember Litigation Whistleblower About About the Firm Firm Story In the Media Our Advantage Contingency Fee Working at Hagens Berman Cycling Teams Success Landmark Cases Victories & Settlements Awards & Recognition Testimonials Contact Contact Us Offices Media Inquiries Careers Alvotech (ALVO) Investigation If you invested in Alvotech and have substantial losses, or have knowledge that may assist the firm’s investigation, submit your losses » CLASS PERIOD N/A LEAD PLAINTIFF DEADLINE N/A STOCK SYMBOL NASDAQ: ALVO CONTACT 844-916-0895 [email protected] The central focus of the inquiry revolves around whether Alvotech provided adequate transparency to the market concerning the status of its Biologics License Application (BLA) for AVT05—a critical biosimilar product—and the underlying manufacturing practices at its flagship Reykjavik facility. The assumptions related to these practices were "baked into" the company's ambitious 2025 revenue projections. On May 8, 2025, Alvotech increased its full year revenue guidance for 2025 to $600-$700 million and full year adjusted EBITDA to $200-$280 million. Three months later, on August 14, 2025, the company reiterated these robust forecasts. Furthermore, in its earnings commentary, management touted its pending marketing application for AVT05 in “major global markets,” asserting this momentum would make "the fourth quarter… by far the strongest one of this year." The narrative of steady growth was abruptly shattered on November 2, 2025, when Alvotech shocked investors when it announced the FDA issued a CRL that disclosed that “[t]e CRL noted that certain deficiencies, which were conveyed following the FDA’s pre-license inspection of Alvotech’s Reykjavik manufacturing facility that concluded in July 2025, must be satisfactorily resolved before this BLA for ATV05 can be approved.” The company reduced its 2025 revenue to $570-$600 million and adjusted EBITDA to just $130-$150 million, respectively. These reductions were critical to investors because they amounted to lowered forecasted revenue range by about 10% below the prior midpoint and a whopping lowered adjusted EBITDA range by about 58% from the prior midpoint. As to the latter, Alvotech stated it was “primarily driven by expected continuation of investments related to resolving certain facility issues, which also require a temporary slowdown in production.” The news sent Alvotech shares crashing about 33% on November 3, 2025, wiping out hundreds of millions of dollars in market value in a single day. FREQUENTLY ASKED QUESTIONS ABOUT THE CASE What is the ALVO investigation about? We are focused on investors’ losses and whether Alvotech may have misled investors about its interactions with the FDA and the commercial prospects of ATV05. WHAT SHOULD I DO? I worked at ALVO. What should I do? If you were an employee of ALVO, you may have valuable information that could be relevant to the investigation. Hagens Berman is one of the nation’s top whistleblower law firms, and has successfully represented many individuals who come forward with information regarding corporate malfeasance. Under the new SEC Whistleblower program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, contact Reed Kathrein at 844-916-0895 or [email protected]. There are multiple law firms participating, do I need to contact all of them? No, you do not need to contact all participating law firms. Generally, class-action investigations and lawsuits are consolidated into a single case to streamline the legal process, and attorneys from only a few law firms are selected to serve in a leadership role on the consolidated case. Hagens Berman has a proven track record of being appointed to leadership roles in complex, multidistrict litigation regarding investor fraud and other consumer rights issues, and your claim will be handled by attorneys who have helped secure approximately $325 billion in class-action settlements on behalf of individuals who have suffered due to corporate malfeasance and the wrongdoing