EXEL · Company research

Exelixis, Inc.

3 upcoming catalysts · 0 phase 2+ trials on file

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Upcoming catalysts

Trial resultsEXELExelixisH2 2026

Exelixis expects to report results from its Phase 3 study of Zanzalintinib (+ nivolumab) for Previously untreated advanced non-clear cell renal cell carcinoma in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.

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Entry

STELLAR-304 Phase 3 topline in non-clear cell RCC · Clinical trial results (readout / topline data)

Drug

Zanzalintinib (+ nivolumab)

For

Previously untreated advanced non-clear cell renal cell carcinoma

Stage

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

When

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

Source note

Exelixis Q2 2026 earnings release (Aug 5, 2026): topline results expected in the second half of 2026, timing dependent on event rates; primary endpoints PFS (BIRC) and ORR vs sunitinib.

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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
EXEL headlines on this site

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

MilestoneEXELExelixisH2 2026

Zanzalintinib Phase 2 STELLAR-202 squamous NSCLC initiation, expected in the second half of 2026 (no exact date yet). A company milestone for Exelixis (zanzalintinib for Squamous non-small cell lung cancer): a step in the program rather than a decision or a data readout.

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Entry

Zanzalintinib Phase 2 STELLAR-202 squamous NSCLC initiation · Company milestone

Drug

zanzalintinib

For

Squamous non-small cell lung cancer

Stage

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

When

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

Source note

Q2 2026 earnings PR (Aug 4, 2026).

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Source: finance.yahoo.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
EXEL headlines on this site

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

FDA decisionEXELExelixisDec 3, 2026

The FDA is due to decide by Dec 3, 2026 whether to approve Exelixis’ Zanzalintinib (+ atezolizumab) for Previously treated non-MSI-high metastatic colorectal cancer. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.

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Entry

PDUFA date for zanzalintinib + atezolizumab in metastatic colorectal cancer · FDA decision due (PDUFA date)

Drug

Zanzalintinib (+ atezolizumab)

For

Previously treated non-MSI-high metastatic colorectal cancer

Stage

NDA under FDA review (standard review)

When

Dec 3, 2026

Source note

FDA accepted the NDA in February 2026 with a PDUFA target action date of December 3, 2026, based on STELLAR-303, which showed a statistically significant overall survival benefit vs regorafenib.

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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
EXEL 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

Trial resultsEXELExelixisJun 22, 2026

Exelixis reported results from its Phase 3 study of zanzalintinib plus atezolizumab (Tecentriq) for Previously treated non-MSI-high metastatic colorectal cancer on Jun 22, 2026. The study missed its main goal.

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Entry

STELLAR-303 missed dual primary OS endpoint in non-liver-metastases subgroup · Clinical trial results (readout / topline data)

Drug

zanzalintinib plus atezolizumab (Tecentriq)

For

Previously treated non-MSI-high metastatic colorectal cancer

Stage

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

When

Jun 22, 2026

Source note

The final analysis of the second dual primary endpoint of STELLAR-303 showed only a non-statistically significant OS trend for zanzalintinib plus atezolizumab versus regorafenib in the non-liver-metastases subgroup (stratified HR 0.83; 95% CI 0.66-1.05; P=0.1185; median OS 15.9 vs 12.7 months). The trial had previously met its ITT OS endpoint, and the NDA carries a December 3, 2026 PDUFA date.

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Source: ir.exelixis.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
EXEL headlines on this site

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

ConferenceEXELExelixisMay 30, 2026

Exelixis presented data on CABOMETYX (cabozantinib) for Previously treated advanced neuroendocrine tumors at a medical meeting on May 30, 2026. The linked source has the details.

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Entry

CABINET ASCO 2026 subgroup: CABOMETYX improved PFS in NET regardless of function · Data presented at a medical meeting

Drug

CABOMETYX (cabozantinib)

For

Previously treated advanced neuroendocrine tumors

Stage

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

When

May 30, 2026

Source note

Exelixis reported a subgroup analysis of the Phase 3 CABINET pivotal trial showing cabozantinib significantly improved progression-free survival versus placebo in previously treated advanced neuroendocrine tumors irrespective of functional status, with a 74% and 60% reduction in risk of progression or death in non-functional and functional NET respectively. Data were presented at ASCO 2026.

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Source: ir.exelixis.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
EXEL headlines on this site

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

MilestoneEXELExelixisH1 2026

Zanzalintinib Phase 3 STELLAR-316 adjuvant MRD+ CRC initiation (mid-2026, nearing start), in the first half of 2026. A company milestone for Exelixis (zanzalintinib for Adjuvant colorectal cancer (MRD-positive, with Merck/Natera)): a step in the program rather than a decision or a data readout.

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Entry

Zanzalintinib Phase 3 STELLAR-316 adjuvant MRD+ CRC initiation (mid-2026, nearing start) · Company milestone

Drug

zanzalintinib

For

Adjuvant colorectal cancer (MRD-positive, with Merck/Natera)

Stage

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

When

H1 2026 · the company gave a window, not a day

Source note

Q2 2026 earnings PR (Aug 4, 2026) describes STELLAR-316 as 'nearing initiation'; guidance remains 'mid-2026' so likely a Q3 2026 start, but no finer timing stated.

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Source: finance.yahoo.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
EXEL 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

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Pipeline trials

ClinicalTrials.gov · phase 2 and later

No phase 2+ trials cached for this company.

Company news

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