StockNews.AI
ALVO
StockNews.AI
1 min

Alvotech (ALVO) Faces Investor Scrutiny Amid Manufacturing Deficiencies Severely Impacting Assurances of 2025 Revenues and Adjusted EBITDA, Stock Tumbles 33% -- Hagens Berman

1. Hagens Berman investigating Alvotech for inadequate financial disclosures. 2. Alvotech's revenue forecasts were drastically revised down due to regulatory issues. 3. Company's stock plummeted 33% after the FDA issued a Complete Response Letter. 4. The investigation focuses on company transparency regarding BLA for AVT05. 5. Whistleblower program may incentivize reporting of non-public info on Alvotech.

6m saved
Insight
Article

FAQ

Why Very Bearish?

The significant drop in revenue projections and the FDA's CRL have severely shaken investor confidence. Historically, similar cases have resulted in long-term stock declines.

How important is it?

The ongoing investigation and drastic revenue adjustments directly threaten ALVO's market credibility and future growth.

Why Short Term?

The immediate reaction to the FDA’s CRL and revised forecasts will likely impact ALVO's stock in the near term.

Related Companies

VRTXAMGNREGN
SAN FRANCISCO, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Shareholder rights firm Hagens Berman is scrutinizing Icelandic biopharmaceutical company Alvotech (NASDAQ: ALVO) over the propriety of its disclosures regarding its lead drug candidate and its manufacturing operations, following a dramatic revision to the company’s full-year financial forecasts. The firm urges investors in Alvotech who suffered significant losses to submit your losses now. The firm also encourages persons with knowledge who may be able to assist in the investigation to contact its attorneys. Visit: www.hbsslaw.com/investor-fraud/alvo Contact the Firm Now: ALVO@hbsslaw.com844-916-0895 Alvotech (ALVO) Investigation: 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. “We’re focused on investors’ losses and whether Alvotech may have misled investors about its interactions with the FDA and the commercial prospects of ATV05,” said Reed Kathrein, the Hagens Berman partner leading the firm’s investigation. 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 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 BermanHagens 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.  Contact: Reed Kathrein, 844-916-0895

Related News