Breaking: IOVA Faces Class Action Lawsuit – Investors Brace for Impact

Biotech stock Iovance Biotherapeutics (IOVA) just got hit with a bombshell class action lawsuit. Here's what you need to know.

Legal storm clouds gather

Shareholders are scrambling as law firms circle—alleging everything from misleading statements to inflated valuations. The usual Wall Street ambulance-chasing routine, but this time targeting a promising immuno-oncology player.

Market fallout begins

While the lawyers line their pockets, retail investors face yet another 'buy the rumor, sell the news' scenario gone wrong. The timing couldn't be worse—just as the broader biotech sector shows signs of life.

Silver lining?

History shows these lawsuits often settle for pennies on the dollar while management collects bonuses. Maybe IOVA's TIL therapy can treat more than just tumors—it might need to cure its own legal headaches next.

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Iovance is a commercial-stage biotechnology company focused on oncology. Iovance is developing tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. The company has launched two treatments in the U.S. market, which are available only at authorized treatment centers (ATCs).

Amtagvi is the first and only FDA-approved, one-time T cell therapy for people with previously treated melanoma that has spread or cannot be removed by surgery. The company also distributes Proleukin, an interleukin-2 product used in conjunction with Amtagvi.

The company’s claims about the prospects of these two products and their related sales expectations are at the heart of the current complaint.

Iovance Biotherapeutics’ Misleading Claims

According to the lawsuit, Iovance and four of its senior officers (the Defendants) repeatedly made false and misleading public statements throughout the Class Period. Particularly, they are accused of omitting truthful information about certain aspects of the company’s growth potential from SEC filings and related material.

During the Class Period, the defendants repeatedly stated that the company was experiencing strong demand for Amtagvi and Proleukin through an expanding network of ATCs.

For instance, in a press release, Iovance provided its Fiscal 2025 product sales forecast, projecting revenues between $450 million and $475 million. The company also said that gross margins were expected to rise to over 70% over the next several years. The company attributed the optimistic outlook to robust growth for Amtagvi, backed by growing demand from existing ATCs and the onboarding of new ATCs.

Additionally, in a November 7, 2024 press release, the company reiterated its FY25 product revenue guidance of between $450 million and $475 million, marking the first full year of Amtagvi sales.

Finally, during a February 27, 2025 earnings call, the then-interim CEO noted, “Our team’s successful execution as well as the unmet need in advanced melanoma, high awareness, broad patient access and a motivated expanding network of authorized treatment centers or ATCs continue to drive increasing demand for Amtagvi and Proleukin.”

However, subsequent events (mentioned below) reveal that the defendants failed to inform investors regarding the potential impact of the annual scheduled maintenance on Amtagvi’s production and sales.

Plaintiffs’ Arguments

The plaintiffs maintain that the defendants deceived investors by lying and withholding critical information about the business and prospects during the Class Period. Importantly, the defendants are accused of misleading investors about the impact of capacity reduction on Amtagvi’s sales, as well as the variable pace at which ATCs began treating patients.

The information became clear on May 8, 2025, when Iovance reported disappointing results for the first quarter of fiscal 2025. What’s worse, the company drastically cut its outlook for FY25. Following the news, IOVA stock plunged 44.8% the next day.

During the related earnings call, the then-interim CEO attributed the weak results and lowered guidance to the three factors mentioned below:

• The completion of annual scheduled maintenance at the company’s internal manufacturing facility, and a significant reduction in capacity for roughly one month due to limited production starts for multi-week Amtagvi manufacturing across the company’s network
• Lower Proleukin sales
• The variable pace at which ATCs began treating patients, which differs from center to center.

To conclude, the company misled investors regarding the potential impact of annual scheduled maintenance and the varying pace of treatment at ATCs on its financial results. Owing to these issues, IOVA stock has declined 72.4% year-to-date, causing massive damage to shareholder returns.