Exelixis, Inc. EXEL
Exelixis, Inc. (Nasdaq: EXEL) is an oncology drug developer. Its lead program, zanzalintinib, is in Phase 3 for metastatic colorectal cancer (CRC). Its next catalyst on record is zanzalintinib + atezolizumab: PDUFA target action date for NDA in metastatic colorectal cancer (March 2027).
Upcoming catalysts
- March 2027zanzalintinib + atezolizumab — PDUFA target action date for NDA in metastatic colorectal cancer
The updated PDUFA target action date is March 3, 2027.
Next further out: zanzalintinib (STELLAR-304) — Top-line results in nccRCC (Q1 2027). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| cabozantinib (CABOMETYX) | advanced renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), differentiated thyroid cancer (DTC), pancreatic/extra-pancreatic neuroendocrine tumors (pNET/epNET) | small molecule | Approved |
| cobimetinib (COTELLIC) | advanced melanoma | small molecule | Approved |
| zanzalintinib | metastatic colorectal cancer | small molecule | Phase 3 |
| zanzalintinib | advanced non-clear cell renal cell carcinoma (nccRCC) | small molecule | Phase 3 |
| zanzalintinib | advanced neuroendocrine tumors (NET) | small molecule | Phase 3 |
| zanzalintinib | resected stage II/III CRC (MRD+) | small molecule | Phase 3 |
| zanzalintinib | recurrent Grade I/II/III meningioma | small molecule | Phase 2 |
| zanzalintinib | maintenance squamous non-small cell lung cancer (NSCLC) | small molecule | Phase 2 |
| XL309 | advanced solid tumors (BRCA-mutated) | small molecule | Phase 1 |
| XB628 | cancer (bispecific antibody targeting PD-L1 and NKG2A) | biologic-other | Phase 1 |
| XB371 | cancer (tissue factor-targeting ADC) | antibody | Phase 1 |
| ADU-1805 | advanced or metastatic refractory solid tumors | antibody | Phase 1 |
Recent results and decisions
- Oct 29, 2026submitted FDA extended the review period for zanzalintinib NDA by three months with updated PDUFA target action date of March 3, 2027.
In September 2026, Exelixis announced that the agency extended the review period for its NDA by three months after the company submitted updated safety and efficacy data in response to an FDA information request.
Filing - started Exelixis initiated STELLAR-202, a phase 2 trial evaluating zanzalintinib plus pembrolizumab in the maintenance setting in squamous NSCLC.
In October 2026, Exelixis initiated STELLAR-202, a phase 2 trial evaluating zanzalintinib in combination with pembrolizumab in the maintenance setting in squamous NSCLC.
Filing - started Exelixis initiated the phase 3 STELLAR-316 pivotal trial evaluating zanzalintinib with and without KEYTRUDA QLEX in resected CRC patients who are MRD+.
In August 2026, Exelixis initiated the phase 3 STELLAR-316 pivotal trial evaluating zanzalintinib, with and without KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph), in patients with resected stage II/III CRC who, following definitive therapy, have tested positive for molecular residual
Filing
2 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
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- Gilead Sciences, Inc. GILD
- Moderna, Inc. MRNA
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Guardant Health, Inc. GH
- Summit Therapeutics Inc. SMMT
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.