Iovance Reports Record Third-Quarter 2026 Product Revenue

The Tip Desk · November 6, 2026 · 3 min read

Third-quarter product revenue hit a record ~$122 million, and the company said it remains on track for $410 million to $420 million for the full year.

Iovance Biotherapeutics (IOVA), a commercial biotechnology company focused on tumor infiltrating lymphocyte therapies, reported record third-quarter product revenue of about $122 million, up about 80% from about $67 million a year earlier and about 22% from about $99 million in the second quarter.

The company said it remains on track for full-year 2026 total product revenue of $410 million to $420 million, after reviewing a prior range of $350 million to $370 million in the second quarter. Interim Chief Executive Officer Frederick Vogt said third-quarter revenue reached a new record with the company’s highest gross margin ever, driven by continued U.S. Amtagvi demand.

U.S. Amtagvi revenue was about $102 million, up about 77% from the year-ago quarter and about 12% from the second quarter. Global Proleukin revenue was about $20 million, compared with about $9 million in the second quarter. Gross margin increased to about 60% from 56% in the second quarter, which the company attributed to higher Amtagvi sales volume and internal cost optimization across product production.

Net loss for the three months ended September 30, 2026 was $22.3 million, or $0.05 a share, versus $91.3 million, or $0.25 a share, a year earlier. Loss from operations narrowed to $24.0 million from $94.9 million a year earlier. Research and development expenses decreased by about 16% compared with the second quarter, the fifth straight quarter of improvements, the company said.

The authorized treatment center network has grown to more than 100 U.S., Canadian, and Australian sites, from more than 95 in the second quarter, with at least 110 expected to be active by the end of 2026. Vogt said the company recently marked more than 1,000 commercially treated Amtagvi patients. Manufacturing turnaround time for the majority of lots is about 30 days or less, the company said.

In the United Kingdom, the marketing authorization application was resubmitted and is undergoing expedited review for potential approval by the first quarter of 2027. A potential Swissmedic approval is also expected in the first quarter of 2027. Iovance is planning to submit an MAA in Brazil in 2027 and an MAA resubmission to the European Medicines Agency is on track for 2027.

The company reported a 24.6% objective response rate in 69 patients with non-squamous metastatic non-small-cell lung cancer in Cohorts 1 and 2 of IOV-LUN-202, including two unconfirmed responses. Those cohorts are completing enrollment, and a supplemental Biologics License Application targeting about 80 patients is planned in 2027. A biomarker-enriched subgroup achieved a 59.1% ORR, prompting the start of POSITILITY, a registrational-intent trial with enrollment beginning in November and a target of 80 patients. The FDA awarded Fast Track Designation for mNSCLC.

In the SARATOGA registrational trial in undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma, the confirmed ORR increased to 55.6% in 9 patients after an updated analysis following ESMO. TILVANCE-301, a Phase 3 trial of lifileucel plus pembrolizumab in frontline advanced melanoma, is enrolling at more than 80 sites.

Cash, cash equivalents, short-term investments, and restricted cash were about $382 million as of September 30, 2026, and the company said current cash is expected to fund operations well into 2029. Improvements in gross margin are expected to continue, excluding occasional one-time items.