Iovance Biotherapeutics NASDAQ: IOVA reported record second-quarter revenue and gross margin, driven by demand for its Amtagvi tumor-infiltrating lymphocyte, or TIL, therapy, as the company expanded its treatment-center network and advanced clinical programs in lung cancer, sarcoma and gynecologic cancers.
Total revenue reached $99.3 million in the second quarter of 2026, up 66% from a year earlier and 39% sequentially. Amtagvi generated approximately $91 million of revenue, exceeding the company’s prior quarterly guidance range of $79 million to $81 million. Proleukin contributed roughly $9 million, compared with $11 million in the first quarter, which Chief Financial Officer Corleen Roche attributed to the timing of wholesaler inventory stocking.
“The second quarter of 2026 was our strongest yet,” Interim Chief Executive Officer and President Fred Vogt said. “We delivered record revenue and margin, advanced our pipeline, and secured important new regulatory approvals and designations.”
Margin Expansion and Guidance Review
Gross margin rose to approximately 56%, from 41% in the first quarter and above the company’s previous high of 50% in the fourth quarter of 2025. Roche said the improvement reflected higher Amtagvi volume, cost optimization and efficiencies from Iovance’s first full quarter of exclusively in-house manufacturing.
Research and development expense declined to about $59 million from $62 million in the prior quarter, marking the fourth consecutive quarter of R&D cost reductions, according to Roche. Selling, general and administrative expense remained essentially flat at approximately $39 million even as revenue increased sequentially.
The company had approximately $304 million in cash equivalents and short-term investments as of June 30 and said it expects that capital to fund operations into the second half of 2028.
Iovance is reviewing its existing full-year 2026 total revenue guidance of $350 million to $370 million following the stronger-than-expected second quarter. Vogt said the company expects to provide an update during the third quarter after evaluating demand trends further.
“Demand trends are very positive right now for the Amtagvi product, and we expect increasing demand Q3 to Q4,” Vogt said during the question-and-answer session. Chief Commercial Officer Dan Kirby added that the company has sufficient visibility into the third quarter to be confident that performance will build on the second quarter.
Commercial Network Expands
Kirby said Iovance had more than 95 authorized treatment centers, or ATCs, and remains on track to reach at least 110 by the end of 2026. Community sites account for about one-third of the network and are expected to expand further in coming quarters.
According to Kirby, the company is providing commercial Amtagvi treatment to more than 50 patients per month. He said physician awareness has increased nearly threefold over the past year, supported by a marketing campaign introduced at the American Society of Clinical Oncology meeting, improved sales-force effectiveness and a growing body of clinical and real-world evidence.
Iovance said more than 75% of Amtagvi patients have private insurance coverage, while payer policies covering more than 250 million lives include the treatment. The company also said more than 95% of addressable U.S. patients live within 200 miles of an ATC, and 80% live within 100 miles.
The company reported a manufacturing turnaround time of 31 days or less through its centralized commercial manufacturing process. Kirby said all three Proleukin wholesalers sold through prior stocking inventory during the second quarter and are ordering in line with Amtagvi demand. Iovance expects Proleukin revenue to grow quarter over quarter and to represent approximately 16% of total revenue on a steady basis for the remainder of the year.
Outside the U.S., Amtagvi has approvals in Canada and Australia. Iovance’s first Canadian ATC is prepared to support international private-pay patients while the company pursues public reimbursement, while Australian sites are being opened for private-pay patients as pricing discussions with the government continue. Regulatory decisions remain pending in the United Kingdom and Switzerland, and Iovance continues to work toward a European Union resubmission.
Pipeline Progress in Lung Cancer, Sarcoma and Other Tumors
Iovance said enrollment is nearly complete in pivotal cohorts of its IOV-LUN-202 registrational trial in non-squamous non-small cell lung cancer. Vogt said the company expects to provide a program update in the fourth quarter and continues to work toward a supplemental Biologics License Application in 2027.
During the call, Vogt said Iovance intends to complete enrollment before issuing a material update, but may not wait for every patient to become evaluable. He said the company is seeing “very strong durability” in the study, without disclosing new data.
The FDA granted Fast Track designation for lifileucel in undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma, two advanced soft tissue sarcoma settings being studied in the registrational SARATOGA trial. Vogt said a pilot study of one-time lifileucel treatment showed a 50% objective response rate among the first six evaluable patients, compared with response rates below 5% using current standard care in those refractory settings.
In the company’s N-201 trial, Iovance reported a 40% confirmed objective response rate and 100% disease control rate among the first five evaluable patients with metastatic serous and endometrial cancer. The company said it is submitting a protocol amendment focused on the serous subtype and is engaging with the FDA regarding an expedited approval pathway.
Iovance also highlighted G1TIL1, a Phase I/II basket trial studying IOV-5001, an IL-12 tethered next-generation TIL therapy, in metastatic colorectal cancer, triple-negative breast cancer and estrogen receptor-low breast cancer.
Separately, Vogt said Iovance plans to present data at the European Society for Medical Oncology meeting from a predecessor Phase II study supporting TILVANCE-301, a blinded randomized trial of Amtagvi plus pembrolizumab in frontline melanoma. He said the presentation will include clinical characteristics such as complete responses in nearly one-third of patients and rapid response velocity, while noting that Iovance cannot evaluate the blinded randomized study at this stage.
About Iovance Biotherapeutics (NASDAQ:IOVA)
Iovance Biotherapeutics, Inc is a clinical‐stage biotechnology company specializing in the development and commercialization of tumor‐infiltrating lymphocyte (TIL) immunotherapies for the treatment of solid tumors. The company's lead product candidate, lifileucel (formerly LN‐144), is an autologous TIL therapy in late‐stage clinical development for patients with advanced melanoma. Iovance's pipeline also includes next‐generation TIL programs such as LN‐145 for cervical and other human papillomavirus (HPV)‐related cancers, as well as exploratory studies in head and neck, non‐small cell lung, gastric and other solid tumor indications.
Iovance's TIL platform harnesses a patient's own immune system by isolating, expanding and reinfusing tumor‐reactive lymphocytes.
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