Iovance Biotherapeutics, Inc. IOVA
Iovance Biotherapeutics, Inc. (Nasdaq: IOVA) is an oncology drug developer. Its lead program, Amtagvi (lifileucel), is in Phase 3 for Previously treated advanced (unresectable or metastatic) melanoma. Its next catalyst on record is Amtagvi: UK MHRA marketing authorization decision (expedited review) (2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: Amtagvi — UK MHRA marketing authorization decision (expedited review) (2026). 5 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Amtagvi (lifileucel) | Previously treated advanced melanoma | cell therapy | Approved |
| Proleukin (aldesleukin) | Metastatic renal cell carcinoma, metastatic melanoma | protein/peptide | Approved |
| Lifileucel + pembrolizumab (TILVANCE-301) | Frontline advanced melanoma (Phase 3 confirmatory) | cell therapy | Phase 3 |
| Lifileucel (IOV-LUN-202) | Previously treated advanced NSCLC (registrational) | cell therapy | Phase 2 |
| Lifileucel | Advanced UPS and DDLPS (registrational trial commenced) | cell therapy | Phase 2 |
Recent results and decisions
- Oct 5, 2026n/a Iovance expanded to approximately 100 authorized treatment centers in North America as of October 5, 2026.
~100 Treatment Centers as of 10/05/26
Filing - Aug 6, 2026n/a FDA granted Fast Track Designation to lifileucel in soft tissue sarcomas (UPS and DDLPS); designation, not an approval decision.
Based on the strength of this early data, FDA granted FTD for UPS and DDLPS.
Filing - Aug 6, 2026submitted UK MAA for Amtagvi was resubmitted in early July 2026 and is under expedited MHRA review; approval possible later in 2026 (ex-US regulator).
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.
Filing
7 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 oncology companies
- Merck & Co., Inc. MRK
- Astrazeneca PLC AZN
- Bristol Myers Squibb Co BMY
- BeOne Medicines Ltd. ONC
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Exelixis, Inc. EXEL
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.