Exelixis, Inc. EXEL
Exelixis, Inc. (Nasdaq: EXEL) is an oncology drug developer. Its lead program, zanzalintinib (+ atezolizumab, STELLAR-303), is in Phase 3 for previously treated metastatic colorectal cancer. Its next catalyst on record is zanzalintinib + atezolizumab (CRC): FDA PDUFA target action date (December 3, 2026).
Upcoming catalysts
- December 3, 2026zanzalintinib + atezolizumab (CRC) — FDA PDUFA target action date
In February 2026, we announced that the FDA had accepted our NDA and assigned a standard review, with a Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026.
Next further out: zanzalintinib + nivolumab (STELLAR-304) — Top-line results (H2 2026). 4 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| zanzalintinib + atezolizumab (STELLAR-303) | metastatic refractory CRC (NDA under review) | small molecule | Phase 3 |
| zanzalintinib + nivolumab (STELLAR-304) | first-line non-clear cell RCC | small molecule | Phase 3 |
| zanzalintinib (STELLAR-311) | advanced neuroendocrine tumors | small molecule | Phase 3 |
| zanzalintinib + belzutifan (LITESPARK-033/-034, Merck-sponsored) | advanced RCC | small molecule | Phase 3 |
| zanzalintinib (STELLAR-316) | resected MRD+ stage II/III CRC | small molecule | Phase 3 |
| zanzalintinib (STELLAR-201) | recurrent meningioma | small molecule | Phase 2 |
| zanzalintinib (STELLAR-202) | squamous NSCLC maintenance | small molecule | Phase 2 |
| XL309 (USP1 inhibitor) | BRCA-mutated / PARPi-resistant solid tumors | small molecule | Phase 1 |
| XB010 (5T4 ADC) | solid tumors | biologic-other | Phase 1 |
| XB628 (PD-L1 x NKG2A bispecific) | solid tumors | antibody | Phase 1 |
| XB371 (TF ADC) | solid tumors | biologic-other | Phase 1 |
| ADU-1805 | advanced solid tumors | antibody | Phase 1 |
Recent results and decisions
- Dec 1, 2025started Merck-sponsored pivotal LITESPARK-033 of zanzalintinib plus WELIREG versus cabozantinib was initiated in December 2025.
LITESPARK-033 was initiated in December 2025 and is the first Merck-sponsored pivotal trial of zanzalintinib and belzutifan in RCC under the companies’ clinical development collaboration.
Filing
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
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.