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SAN CARLOS, Calif. - Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company with a market capitalization of $584 million, announced today that the Journal of Clinical Oncology has published the final five-year results from the Phase 2 C-144-01 clinical trial of Amtagvi, a novel T cell therapy for advanced melanoma. The study shows sustained responses and survival benefits in patients who had previously undergone anti-PD-1 and targeted therapy. According to InvestingPro data, while the company maintains a strong balance sheet with more cash than debt, it faces challenges with rapid cash burn as it advances its clinical programs.
The trial included 153 melanoma patients who received a one-time treatment with Amtagvi (lifileucel). The therapy demonstrated a 31.4% objective response rate with a median time to response of 1.4 months and a median duration of response of 36.5 months. Notably, nearly one-third of the responders had ongoing responses at the five-year mark. Median overall survival was 13.9 months, with a five-year survival rate of 19.7%. Despite these promising clinical results, the stock has faced significant pressure, trading near its 52-week low of $1.64.
Theresa Medina, M.D., from the University of Colorado Cancer Center, highlighted Amtagvi’s significance in providing a new standard of care for advanced melanoma, especially for those resistant to immune checkpoint inhibitor therapy.
The U.S. Food and Drug Administration granted accelerated approval to Amtagvi in February 2024, making it the first one-time T cell therapy approved for a solid tumor cancer and for advanced melanoma following anti-PD-1 and targeted therapy.
The safety profile of Amtagvi was consistent with nonmyeloablative lymphodepletion and interleukin-2 administration, with no new or late-onset adverse events reported. Side effects decreased rapidly within the first two weeks post-infusion.
Iovance is also conducting a Phase 3 trial, TILVANCE-301, to confirm Amtagvi’s clinical benefit in frontline advanced melanoma.
The information in this article is based on a press release statement from Iovance Biotherapeutics, Inc.
In other recent news, Iovance Biotherapeutics reported a first-quarter 2025 loss per share of $0.36, falling short of the analyst consensus estimate of $0.24. The company’s revenue for the quarter was $49.3 million, which also missed expectations set at $83.27 million. This shortfall prompted Iovance to lower its full-year 2025 revenue guidance to between $250 million and $300 million. UBS analysts responded by downgrading Iovance’s stock from "Buy" to "Neutral," citing slower-than-anticipated sales of Amtagvi and reducing the price target from $17.00 to $2.00. Similarly, Truist Securities downgraded the stock from "Buy" to "Hold," highlighting market challenges and performance inconsistencies. Meanwhile, H.C. Wainwright adjusted its price target for Iovance to $20.00 from $32.00 but maintained a "Buy" rating, reflecting optimism about the company’s long-term potential. Despite these financial setbacks, Iovance’s management remains optimistic, citing the treatment of over 275 Amtagvi patients and revenue generation of more than $210 million in the first 12 months post-launch. The company also anticipates regulatory approvals for Amtagvi in the UK, EU, and Canada.
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