IOVA · Company research

Iovance Biotherapeutics, Inc.

7 upcoming catalysts · 0 phase 2+ trials on file

View Stock opens Yahoo Finance. Prices and performance charts are provided there.

Upcoming catalysts

ApprovalIOVAIovance BiotherapeuticsH2 2026

Iovance Biotherapeutics expects UK regulators to decide on lifileucel (Amtagvi) for advanced melanoma in the second half of 2026 (no exact date yet). An approval lets the company start selling it in that market.

More details

Entry

Potential UK (MHRA) approval of Amtagvi in advanced melanoma · Regulatory approval

Drug

lifileucel (Amtagvi)

For

advanced melanoma

Stage

Regulatory review (expedited MHRA pathway)

When

H2 2026 · the company gave a window, not a day

Source note

Company guidance: potential UK approval "later in 2026" via expedited MHRA review.

Checked

Checked by a person when it was added

Verify it

Source: biospace.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
Drugs@FDA ↗ — search the drug name for approval letters
IOVA headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

ConferenceIOVAIovance BiotherapeuticsOct 2026

Iovance Biotherapeutics presents data on lifileucel (Amtagvi) / TIL therapy for undifferentiated pleomorphic sarcoma / dedifferentiated liposarcoma (UPS/DDLPS) at a medical meeting in Oct 2026 (no exact date yet). New numbers at a conference can move the stock as much as a formal announcement.

More details

Entry

SARATOGA data oral presentation at ESMO 2026 · Data presented at a medical meeting

Drug

lifileucel (Amtagvi) / TIL therapy

For

undifferentiated pleomorphic sarcoma / dedifferentiated liposarcoma (UPS/DDLPS)

Stage

Clinical trial results

When

Oct 2026 · the company gave a window, not a day

Source note

Results to be highlighted in an oral presentation at the European Society for Medical Oncology (ESMO) meeting in Madrid, October 23-27, 2026, per company Q2 2026 press release.

Checked

Checked by a person when it was added

Verify it

Source: biospace.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
IOVA headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

ConferenceIOVAIovance BiotherapeuticsOct 2026

Iovance Biotherapeutics presents data on lifileucel (Amtagvi) + pembrolizumab for frontline advanced melanoma at a medical meeting in Oct 2026 (no exact date yet). New numbers at a conference can move the stock as much as a formal announcement.

More details

Entry

TILVANCE-301 lifileucel + pembrolizumab frontline melanoma oral at ESMO 2026 · Data presented at a medical meeting

Drug

lifileucel (Amtagvi) + pembrolizumab

For

frontline advanced melanoma

Stage

Phase 3 · the last stage before a drug can be approved

When

Oct 2026 · the company gave a window, not a day

Source note

Q2 2026 results PR (Aug 6, 2026). ESMO 2026 runs Oct 23-27 in Madrid. Separate from the SARATOGA oral (#3725RO) already tracked.

Checked

Checked by a person when it was added

Verify it

Source: biospace.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
IOVA headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsIOVAIovance BiotherapeuticsQ4 2026

Iovance Biotherapeutics expects to report results from its Phase 2 study of lifileucel for post-anti-PD-1 metastatic nonsquamous NSCLC in Q4 2026 (Oct–Dec) (no exact date yet). Phase 2 is the stage that tests whether the drug actually works.

More details

Entry

IOV-LUN-202 NSCLC registrational program updates · Clinical trial results (readout / topline data)

Drug

lifileucel

For

post-anti-PD-1 metastatic nonsquamous NSCLC

Stage

Phase 2 · the stage that tests whether the drug actually works

When

Q4 2026 · the company gave a window, not a day

Source note

Enrollment nearly complete in the pivotal cohorts; "program updates are expected in 4Q26" per Q2 2026 press release. Fast Track designation granted.

Checked

Checked by a person when it was added

Verify it

Source: biospace.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
IOVA headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

ApprovalIOVAIovance BiotherapeuticsH1 2027

Iovance Biotherapeutics expects regulators to decide on lifileucel (Amtagvi) for advanced melanoma in the first half of 2027 (no exact date yet). An approval lets the company start selling it in that market.

More details

Entry

Potential Switzerland (Swissmedic) approval of Amtagvi · Regulatory approval

Drug

lifileucel (Amtagvi)

For

advanced melanoma

Stage

Regulatory review

When

H1 2027 · the company gave a window, not a day

Source note

Company guidance: Switzerland approval "expected in 1H27".

Checked

Checked by a person when it was added

Verify it

Source: biospace.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
Drugs@FDA ↗ — search the drug name for approval letters
IOVA headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsIOVAIovance BiotherapeuticsH1 2027

Iovance Biotherapeutics expects to report results from its investigator-sponsored study of lifileucel for CSCC / MCC in the first half of 2027 (no exact date yet). This is the first look at whether the drug did what the company hoped.

More details

Entry

Initial lifileucel data in cutaneous SCC and Merkel cell carcinoma · Clinical trial results (readout / topline data)

Drug

lifileucel

For

CSCC / MCC

Stage

investigator-sponsored

When

H1 2027 · the company gave a window, not a day

Source note

Q2 2026 results PR (Aug 6, 2026). Investigator-sponsored trials.

Checked

Checked by a person when it was added

Verify it

Source: biospace.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
IOVA headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

MilestoneIOVAIovance Biotherapeutics2027

Amtagvi sBLA submission in nonsquamous NSCLC (IOV-LUN-202), expected during 2027 (no exact date yet). A company milestone for Iovance Biotherapeutics (lifileucel (Amtagvi) for post-anti-PD-1 metastatic nonsquamous NSCLC): a step in the program rather than a decision or a data readout.

More details

Entry

Amtagvi sBLA submission in nonsquamous NSCLC (IOV-LUN-202) · Company milestone

Drug

lifileucel (Amtagvi)

For

post-anti-PD-1 metastatic nonsquamous NSCLC

Stage

sBLA planned

When

2027 · the company gave a window, not a day

Source note

"A supplemental Biologics License Application (sBLA) submission is planned in 2027" (year-level guidance only).

Checked

Checked by a person when it was added

Verify it

Source: biospace.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
IOVA headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Past catalysts

MilestoneIOVAIovance BiotherapeuticsAug 6, 2026

FDA grants Fast Track to lifileucel in soft tissue sarcomas, on Aug 6, 2026. A company milestone for Iovance Biotherapeutics (Amtagvi (lifileucel) for Soft tissue sarcomas (UPS/DDLPS)): a step in the program rather than a decision or a data readout.

More details

Entry

FDA grants Fast Track to lifileucel in soft tissue sarcomas · Company milestone

Drug

Amtagvi (lifileucel)

For

Soft tissue sarcomas (UPS/DDLPS)

Stage

Registrational (SARATOGA) · a study designed to support approval

When

Aug 6, 2026

Source note

Iovance disclosed that FDA granted Fast Track Designation for lifileucel in soft tissue sarcomas, alongside the new registrational SARATOGA trial in undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma.

Checked

Checked by a person when it was added

Verify it

Source: ir.iovance.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
IOVA headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

ApprovalIOVAIovance BiotherapeuticsJun 3, 2026

Regulators approved Iovance Biotherapeutics’ Amtagvi (lifileucel) for Previously treated advanced melanoma (Australia) on Jun 3, 2026. The company can now sell it in that market.

More details

Entry

Australia's TGA approves Amtagvi for previously treated advanced melanoma · Regulatory approval

Drug

Amtagvi (lifileucel)

For

Previously treated advanced melanoma (Australia)

Stage

Approved

When

Jun 3, 2026

Source note

Australia's Therapeutic Goods Administration granted approval with conditions for Amtagvi (lifileucel) in previously treated metastatic or unresectable melanoma, the first T cell therapy approved in Australia for a solid tumor.

Checked

Checked by a person when it was added

Verify it

Source: ir.iovance.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
Drugs@FDA ↗ — search the drug name for approval letters
IOVA headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

MilestoneIOVAIovance BiotherapeuticsJun 1, 2026

FDA clears IND for IL-12 tethered TIL therapy IOV-5001, on Jun 1, 2026. A company milestone for Iovance Biotherapeutics (IOV-5001 for Solid tumors (basket trial)): a step in the program rather than a decision or a data readout.

More details

Entry

FDA clears IND for IL-12 tethered TIL therapy IOV-5001 · Company milestone

Drug

IOV-5001

For

Solid tumors (basket trial)

Stage

Phase 1/2 · an early study that checks safety and takes a first look at effect

When

Jun 1, 2026

Source note

FDA allowed Iovance's IND to proceed for a Phase 1/2 basket trial of IOV-5001, a next-generation IL-12 tethered TIL therapy, with enrollment set to begin in the second half of 2026.

Checked

Checked by a person when it was added

Verify it

Source: ir.iovance.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
IOVA headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

ApprovalIOVAIovance BiotherapeuticsFeb 16, 2024

The FDA approved Iovance Biotherapeutics’ Amtagvi (lifileucel) for Melanoma on Feb 16, 2024. The company can now sell it in that market.

More details

Entry

FDA accelerated approval of Amtagvi · Regulatory approval

Drug

Amtagvi (lifileucel)

For

Melanoma

When

Feb 16, 2024

Source note

First TIL cell therapy approved for advanced melanoma.

Checked

Checked by a person when it was added

Verify it

SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
Drugs@FDA ↗ — search the drug name for approval letters
IOVA headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Things of Interest

Explore reported politician transactions and public investor statements connected to IOVA.

View source-linked activity ↗

Pipeline trials

ClinicalTrials.gov · phase 2 and later

No phase 2+ trials cached for this company.

Company news

No recent headlines on file.