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Iovance posts record Q3 revenue near $122M and reaffirms 2026 guidance

🇺🇸 Iovance Biotherapeutics, Inc. (IOVA) · Thu 05 Nov 2026

Amtagvi sales of about $102M in the US drove an roughly 80% year-on-year rise, while UK and Swiss decisions are possible in the first quarter of 2027.

Iovance Biotherapeutics reported on 5 November 2026 that product revenue for the third quarter reached about $122M, an increase of roughly 80% on the same period a year earlier. The company described the result as a record.

US sales of Amtagvi (lifileucel) accounted for about $102M of the total, and gross margin was close to 60%. Iovance kept its full-year 2026 revenue guidance at $410-420M.

On the regulatory front, the company said decisions from the UK Medicines and Healthcare products Regulatory Agency (MHRA) and from Swissmedic are possible in the first quarter of 2027. It also plans to file a supplemental biologics licence application (sBLA) in 2027 for non-squamous metastatic non-small cell lung cancer (NSCLC).

Iovance also noted FDA Fast Track designations for NSCLC and for the sarcoma subtypes UPS and DDLPS. The registrational trials POSITILITY and SARATOGA are underway. The summary available does not give further detail on trial design, timelines or data.

What it means for your team

  • Regulatory teams should note the possible MHRA and Swissmedic decisions in 1Q27, which would extend Amtagvi's approvals beyond the US if granted.
  • The planned 2027 sBLA in non-squamous metastatic NSCLC points to a future label-expansion review at the FDA.
  • Market-access teams may want to watch how the US uptake reflected in about $102M of quarterly Amtagvi sales develops against the $410-420M full-year guidance.
  • Fast Track status for NSCLC and UPS/DDLPS sarcomas signals potential for more frequent FDA interaction during development, though it does not guarantee approval.

Company's press release (SEC filing): Iovance Biotherapeutics, Inc. ↗

Article written by VigiEye from the official source (Iovance Biotherapeutics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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