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TORONTO - Health Canada has granted conditional approval for Amtagvi (lifileucel), the first T cell therapy for solid tumor cancer, to treat advanced melanoma patients who have exhausted other treatment options, Iovance Biotherapeutics (NASDAQ:IOVA) announced Monday. The news has contributed to the company’s impressive 29.4% surge over the past week, according to InvestingPro data.
The Notice of Compliance with Conditions (NOC/c) allows Amtagvi to be used in adult patients with unresectable or metastatic melanoma that has progressed after at least one prior systemic therapy, including a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
This marks Iovance’s first marketing authorization outside the United States, where the therapy received FDA approval earlier. The company expects to authorize its first Canadian treatment center within the next few months.
"This approval in Canada marks a significant step forward for Iovance as we prepare to introduce Amtagvi in countries with a high prevalence of advanced melanoma," said Frederick Vogt, Interim Chief Executive Officer and President of Iovance. The company maintains a strong financial position with more cash than debt on its balance sheet and a healthy current ratio of 3.27, indicating solid short-term liquidity.
The approval was based on results from the global, multicenter C-144-01 trial, which evaluated Amtagvi in previously treated advanced melanoma patients. The conditional approval requires Iovance to provide additional confirmatory trial results.
Amtagvi is a tumor-derived autologous T cell immunotherapy, also known as tumor infiltrating lymphocyte (TIL) therapy, which harnesses a patient’s own immune cells to target cancer.
According to the press release statement, Iovance is currently investigating Amtagvi in frontline advanced melanoma in a Phase 3 trial called TILVANCE-301, as well as in additional solid tumor types. While InvestingPro analysis indicates the company is currently undervalued, analysts have recently revised their earnings expectations upward for the upcoming period. For deeper insights into IOVA’s valuation and growth potential, including 11 additional ProTips and comprehensive financial metrics, check out the full Pro Research Report available on InvestingPro.
In other recent news, Iovance Biotherapeutics Inc. reported its financial results for the second quarter of 2025, missing revenue forecasts. The company posted earnings per share of -$0.33, which was below the anticipated -$0.28, resulting in a 17.86% negative surprise. Revenue for the quarter reached $60 million, falling short of the $67.1 million forecast and leading to a 10.58% revenue surprise. Despite this miss, the company highlighted promising growth in its key product lines. These developments have drawn attention from investors and analysts alike. The earnings report reflects challenges the company faces in meeting market expectations. Analysts and investors will likely continue to monitor Iovance Biotherapeutics’ financial performance closely in the coming quarters.
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