Iovance Biotherapeutics Withdraws Amtagvi EU Filing, Stock Plunges 29% Despite Strong Q2 Sales
核心洞察
Iovance Biotherapeutics voluntarily withdrew its European Union regulatory filing for Amtagvi due to lack of alignment with the EMA on clinical data supporting the submission.
The company reported strong Q2 Amtagvi sales of $54.1 million, beating estimates and driven by over 100 patient infusions during the quarter.
Shares plummeted nearly 29% in after-market trading following the EMA withdrawal announcement, contributing to a 64% year-to-date decline.
Iovance Biotherapeutics faced a significant setback as the company voluntarily withdrew its regulatory filing for Amtagvi in the European Union due to a lack of alignment with the EMA on clinical data supporting the submission. The announcement triggered a sharp 29% decline in after-market trading, adding to the company's challenging year that has seen shares plunge 64% year-to-date.
Strong Amtagvi Sales Performance Despite Regulatory Setback
Despite the regulatory challenges, Iovance reported robust performance for its TIL therapy Amtagvi during the second quarter of 2025. The company recorded $54.1 million from Amtagvi sales, compared with $43.6 million in the previous quarter, driven by strong demand for the advanced melanoma (搜索) treatment. This figure marginally beat both the Zacks Consensus Estimate of $53.3 million and analyst model estimates of $53.5 million.
The company reported that over 100 patients were infused with Amtagvi during the quarter, demonstrating continued clinical adoption of the therapy. Amtagvi is currently approved for the advanced melanoma (搜索) indication and represents a significant portion of Iovance's revenue stream.
Mixed Q2 Financial Results
Iovance reported a second-quarter 2025 loss of 33 cents per share, wider than the Zacks Consensus Estimate of a loss of 29 cents, though improved from the year-ago quarter's loss of 34 cents per share. Quarterly revenues rose 93% year over year to $60.0 million, entirely from sales of its two marketed drugs, but missed the Zacks Consensus Estimate of $66.4 million.
The company's other marketed product, Proleukin, an IL-2 therapy approved to treat metastatic renal cell carcinoma (搜索) and metastatic melanoma (搜索) in adults, contributed $5.9 million during the quarter, down 68% year over year and missing both consensus and model estimates of $18 million.
Strategic Restructuring and Cost Management
Alongside the earnings results, Iovance announced a strategic restructuring plan designed to save more than $100 million annually in costs starting in 2025. The company plans to lay off nearly 19% of its workforce before the end of next month and optimize its cost structure over the next two to three quarters.
Based on this restructuring plan, Iovance expects net cash burn for the next four quarters through the second quarter of 2026 to be less than $245 million. The cost savings are expected to extend the existing cash runway into the fourth quarter of 2026.
Research and development expenses totaled $79.4 million, up 28% from the year-ago quarter, driven primarily by higher employee costs and clinical expenses. Selling, general and administrative expenses declined 5% to $37.7 million, primarily due to reduced stock compensation expenses.
Pipeline Development and Regulatory Strategy
Despite the EU setback, regulatory applications for Amtagvi in the melanoma indication remain under review in the United Kingdom, Canada and Australia, with potential approvals expected throughout this year and early next year. The company stated it is developing a new strategy for seeking EU approval, though this delays initial plans of securing approval before year-end.
Iovance is evaluating Amtagvi in combination with Merck (搜索)'s PD-L1 (搜索) inhibitor Keytruda in the phase III TILVANCE-301 study as a potential treatment for frontline advanced melanoma (搜索). This study will also serve as a confirmatory study seeking full approval for Amtagvi in the melanoma indication.
The company remains on track to share an update from the phase II IOV-LUN-202 study, evaluating Amtagvi in post-anti-PD-1 non-small cell lung cancer (搜索) (NSCLC), before year-end. If results are positive, Iovance expects to secure label expansion from the FDA in this indication in 2027.
Future Outlook and Revenue Guidance
Iovance reiterated its product revenue guidance for the full year at between $250 million and $300 million, driven by strong demand for both marketed products. The company expects significant growth in total product revenues for 2026 and beyond, with gross margins expected to increase through optimization of manufacturing capacity utilization over the next several years.
Additional pipeline developments include separate mid-stage studies evaluating Amtagvi for cervical and endometrial cancer (搜索) indications, with initial results from the endometrial cancer study expected by year-end. The company also expects to report data from the efficacy portion of the phase II IOV-GM1-201 study, evaluating IOV-4001 in previously treated advanced melanoma (搜索), later this year.