IOVA biotech catalysts & pipeline

IOVANCE BIOTHERAPEUTICS INC · Data as of 2026-10-25

Upcoming catalysts

Amtagvi (lifileucel) — Regulatory decision

2026

The MAA for Amtagvi in the UK was resubmitted in early July and is undergoing expedited review by the Medicines and Healthcare products Regulatory Agency (MHRA) for potential approval later in 2026.

Source filing

Amtagvi (lifileucel) — Initial data

Oct 26

Iovance will also present the first clinical data for lifileucel in soft tissue sarcomas in a Rapid Oral presentation on Monday, October 26, 2026 ( Abstract #3725RO ).

Source filing

Amtagvi (lifileucel) — Initial data

1H27

Multiple patients have been treated for cutaneous squamous cell carcinoma (CSCC) and Merkel cell carcinoma (MCC) with initial data expected in 1H27.

Source filing

Amtagvi (lifileucel) — Regulatory decision

1H27

Potential approval of the MAA in Switzerland is expected in 1H27, opening a second market opportunity in Europe with the potential for medical tourism.

Source filing

Amtagvi (lifileucel) — NDA/BLA submission

2027

An MAA resubmission for Amtagvi in advanced melanoma to the European Medicines Agency is on track for 2027.

Source filing

Amtagvi (lifileucel) — Conference presentation

2026

Updated data at a major medical meeting in 2026.

Source filing

Amtagvi (lifileucel) — Conference presentation

Oct 23–Oct 27

Results will be highlighted in an oral presentation (abstract #3725RO) at the European Society for Medical Oncology (ESMO) meeting in Madrid, Spain, from October 23–27, 2026.

Source filing

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