Iovance Biotherapeutics, Inc. (IOVA) is trading sharply higher in today's session climbing more than 22% as the company reports positive early results from the first clinical trial of its TIL cell therapy in soft tissue sarcomas and highlights strong fourth-quarter and full-year 2025 financial performance.
The company announced that Lifileucel, its one-time tumor- infiltrating lymphocyte (TIL) therapy, shows a 50% confirmed objective response rate (ORR) among the first six evaluable patients with advanced undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) in a pilot study led by Memorial Sloan Kettering Cancer Center. All patients in the cohort have advanced, refractory disease with significant tumor burden, and responses deepen over time, consistent with Lifileucel's activity in melanoma and lung cancer.
Based on these results, Iovance plans to begin a single-arm registrational trial in second-line UPS and DDLPS in the second quarter of 2026 and will engage with the FDA on an expedited approval pathway. The company also intends to explore Lifileucel in additional high-grade sarcoma subtypes with high unmet need.
Alongside the clinical update, Iovance reports approximately 30% quarter-over-quarter revenue growth in Q4 2025, driven by increasing demand for Amtagvi, the first FDA-approved T-cell therapy for a solid tumor.
Fourth-quarter product revenue totals approximately $87 million compared to $73.9 million from the year-ago-quarter.
U.S. Amtagvi sales were $65 million in Q4 2025, compared to $48.7 million in the year ago quarter and approximately $22 million from global Proleukin revenue, compared to $25.0 million.
For full-year 2025, Iovance reported $264 million in total product revenue, meeting its guidance range of $250-$300 million, compared to $164 million in the previous year.
This included $220 million from the U.S Amtagiv sales, compared to $103.6 million in the prior year and $44 million from global Proleukin revenue, compared to $60.5 million in the year ago.
Iovance also highlighted continued commercial momentum for Amtagvi, including expanding U.S. treatment centers, strong real-world response rates, and ongoing global regulatory submissions.
Meanwhile, Lifileucel continues to advance across multiple solid tumor programs including a registrational trial in advanced non-small cell lung cancer and the global Phase 3 TILVANCE-301 study in frontline melanoma.
The company ended December 31, 2025, with approximately $303 million in cash, cash equivalents, and short-term investments, which is expected to fund operations into the third quarter of 2027.
IOVA has traded between $1.64 and $5.88 over the past year. The stock is currently trading at $3.63, up 25.61%.
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June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.