Information
SAN FRANCISCO, Jan. 14, 2026 /PRNewswire/ -- National shareholder rights firm Hagens Berman is investigating Alvotech (NASDAQ:ALVO) regarding the propriety of its disclosures concerning the company's manufacturing
Original sourceAI Summary
Alvotech is under investigation by Hagens Berman for potentially misleading disclosures concerning its manufacturing operations and the regulatory status of AVT05, following a 34% stock drop after receiving an FDA Complete Response Letter. The investigation could lead to legal repercussions for the company and further price volatility.
Sentiment Rationale
The regulatory issues and investigation create significant uncertainty for ALVO, similar to past examples where companies faced severe legal repercussions and stock declines, e.g., Valeant Pharmaceuticals.
Trading Thesis
Given potential legal risks, consider ALVO as a sell in the short term.
Market-Moving
- FDA's CRL response triggered a massive sell-off in ALVO shares.
- Ongoing investigation may lead to further price declines if allegations are substantiated.
- Investor sentiment may remain negative until clarity is provided on the situation.
Key Facts
- Hagens Berman investigates Alvotech's disclosures on AVT05 manufacturing.
- Alvotech's stock plummeted 34% after receiving FDA's CRL for AVT05.
- The investigation examines potential misleading statements by Alvotech.
- Company cut its 2025 revenue and EBITDA outlook significantly.
- Investors encouraged to contact the firm regarding potential losses.
Companies Mentioned
- Hagens Berman (N/A): Investigating Alvotech for potentially misleading statements impacting investor losses.
Corporate Developments
This fits the 'Corporate Developments' category due to the legal investigation and potential securities fraud claims affecting investor trust and stock performance.
SAN FRANCISCO, Jan. 14, 2026 /PRNewswire/ -- National shareholder rights firm Hagens Berman is investigating Alvotech (NASDAQ:ALVO) regarding the propriety of its disclosures concerning the company's manufacturing operations and the regulatory status of its lead biosimilar candidate, AVT05.
The investigation follows a staggering 34% stock drop after Alvotech revealed it received a "Complete Response Letter" (CRL) from the FDA. Investors who purchased Alvotech (ALVO) securities and suffered significant losses are encouraged to contact the firm.
[CLICK HERE TO SUBMIT YOUR ALVOTECH LOSSES]
ALVO Investigation at a Glance
Key Detail | Information for ALVO Investors |
Ticker Symbol | ALVO (NASDAQ) |
Trigger Event | FDA Complete Response Letter (CRL) for AVT05 |
Stock Price Drop | -34% in a single trading session |
Contact the Firm Now | ALVO@hbsslaw.com / 844-916-0895 |
Alvotech (ALVO) Investigation:
The investigation focuses on whether Alvotech misled investors about the readiness of its Reykjavik, Iceland, manufacturing facility to meet FDA standards. Throughout 2025, Alvotech management repeatedly touted the commercial prospects of AVT05 (a biosimilar to Simponi®) and even raised its full-year revenue guidance to as high as $700 million.
But on November 2, 2025, Alvotech shocked investors when it announced that the FDA had issued a CRL for AVT05, citing "certain deficiencies" found during a July 2025 inspection of the Reykjavik plant. As a result, Alvotech was forced to slash its 2025 revenue guidance and cut its adjusted EBITDA outlook by a staggering 58%. On this news, Alvotech's stock price crashed 34%, falling from $7.65 to $5.03 in one day.
"We are looking into whether Alvotech was aware of these significant manufacturing failures months before they admitted them to the public," said Reed Kathrein, the Hagens Berman partner leading the firm's investigation.
Frequently Asked Questions (FAQs)
Why is Hagens Berman investigating Alvotech (ALVO)? The firm is investigating whether Alvotech issued false or misleading statements regarding its manufacturing capabilities and the likelihood of FDA approval for its biosimilar pipeline.
What is an FDA CRL and why did it hurt ALVO stock? A Complete Response Letter (CRL) is an FDA communication stating that an application will not be approved in its current form. For Alvotech, this CRL indicated manufacturing deficiencies that allegedly caused the company to significantly downgrade its 2025 financial projections, wiping out significant market cap.
How can I help the Alvotech investigation? Hagens Berman is interested in speaking with anyone who has non-public information about Alvotech's Reykjavik facility or internal FDA communications.
If you invested in Alvotech and have substantial losses, or have knowledge that may assist the firm's investigation, submit your losses now »
If you'd like more information and answers to additional frequently asked questions about the Alvotech investigation, read more »
Whistleblowers: Persons with non-public information regarding Alvotech should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new 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, call Reed Kathrein at 844-916-0895 or email ALVO@hbsslaw.com.
About Hagens Berman
Hagens Berman is a global plaintiffs' rights complex litigation firm focusing on corporate accountability. The firm is home to a robust practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and other wrongdoings. Hagens Berman's team has secured more than $2.9 billion in this area of law. More about the firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw.
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SOURCE Hagens Berman Sobol Shapiro LLP