Alvotech Faces Rough Waters as Manufacturing Issues Raise Investor Concern and Stock Value Plummets

Alvotech Struggles Under Investor Scrutiny

Alvotech (NASDAQ: ALVO), an Icelandic biopharmaceutical firm, is currently under the magnifying glass of investor rights law firm Hagens Berman. The scrutiny comes in light of significant concerns around the company's manufacturing processes and financial projections. Recent announcements regarding its main drug candidate have raised suspicions about the transparency of its operational practices and financial reassurances provided to shareholders.

The situation escalated dramatically on November 2, 2025, when the company revealed that the FDA had issued a Complete Response Letter (CRL) concerning Alvotech's Biologics License Application (BLA) for AVT05, a critical biosimilar product. This CRL indicated several deficiencies observed during a pre-license inspection of its facility in Reykjavik conducted earlier in the year. As a result of these complications, Alvotech's anticipated full-year revenue for 2025 was slashed from predictions of $600-$700 million down to $570-$600 million, with adjusted EBITDA expectations dropping drastically from $200-$280 million to below $150 million.

In the months leading up to this downturn, investor confidence was buoyed by optimistic forecasts. For instance, on May 8, 2025, Alvotech projected a solid revenue forecast, only to reaffirm these figures later in August. The company's management painted a picture of continued growth and emphasized the momentum expected from pending marketing applications across significant global markets. However, this narrative crumbled in the fallout of the FDA's announcement, resulting in a 33% drop in stock price on November 3, demonstrating a sharp loss of hundreds of millions in market capitalization.

Hagens Berman's investigation centers around allegations that Alvotech may have misled investors concerning its manufacturing capabilities and communication with the FDA. Reed Kathrein, a partner at Hagens Berman, stated, "We are focused on investors' losses and whether Alvotech may have misled investors about its interactions with the FDA and the commercial prospects of AVT05." The firm encourages affected investors or individuals with pertinent information about Alvotech to step forward.

The implications of these developments are multifaceted, affecting not only Alvotech’s stock value but also its reputation within the highly competitive biopharmaceutical landscape. Investors who had placed significant financial faith in Alvotech's projections now face a stark reality that compels them to reassess their positions in light of the unfolding situation.

This incident highlights the profound impact that regulatory feedback can have on companies within the pharmaceutical industry, particularly for those that hinge their strategies on the success of critical product launches. The road ahead for Alvotech remains fraught with challenges, as it not only has to resolve its manufacturing issues but also regain investor confidence—a daunting task amidst scrutiny and tightening financial forecasts.

Additionally, whistleblowers possessing non-public information about Alvotech are encouraged to engage with Hagens Berman, as the SEC has established protections and reward structures for individuals who provide valuable insights regarding corporate malfeasance. The firm emphasizes that firsthand information may lead to significant financial incentives for whistleblowers.

As Alvotech navigates this turbulent chapter, all eyes are on how the company will manage its response to regulatory feedback and investor anxiety while striving to uphold its product development ambitions for the future.