Name in SEC filings: EXELIXIS, INC.
| Program | Event | Stage | Stated timing | Filing |
|---|---|---|---|---|
| cabozantinib + atezolizumab | submission | — | during the fourth quarter of 2024 | 10-Q · |
| cabozantinib | Advisory committee | Stage not stated | March 2025 | SEC filing · |
| cabozantinib | target date (company stated) | PDUFA | April 3, 2025 | SEC filing · |
| zanzalintinib and atezolizumab | PDUFA target date (company stated) | PDUFA | December 3, 2026 | SEC filing · |
| zanzalintinib | /data readout | Phase 3 | Second Half of 2026 | EX-99.1 · |
Source: ORION, orionbiotechai.com/company/EXEL, data as of Oct 18, 2026
https://www.orionbiotechai.com/company/EXEL
zanzalintinib and atezolizumab · PDUFA target date (company stated) · December 3, 2026
SEC sources last checked .
○ Quote matched to filing (not yet reviewed by founder) · ✓ Checked by founder.
metastatic castration-resistant prostate cancer
NDA/BLA submissionduring the fourth quarter of 2024
Stage: —
Public float: $9,400,000,000 · as of · SEC filing
We intend to submit an sNDA to the FDA during the fourth quarter of 2024.
10-Q · Filed · Last checked
Resolution filing: · SEC filing
Alert me · Calendar: same stage and window-end month (2024-12)
previously treated advanced pancreatic and extra-pancreatic neuroendocrine tumors
Advisory committeeMarch 2025
Stage: Not stated
Public float: $9,400,000,000 · as of · SEC filing
In November 2024, we announced that our sNDA would be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025
SEC filing · Filed · Last checked
Resolution filing: · SEC filing
Alert me · Calendar: same stage and window-end month (2025-03)
previously treated advanced pancreatic and extra-pancreatic neuroendocrine tumors
PDUFA target date (company stated)April 3, 2025
Stage: PDUFASEC filing · “PDUFA) target action date”
Public float: $9,400,000,000 · as of · SEC filing
Prescription Drug User Fee Act (PDUFA) target action date of April 3, 2025
SEC filing · Filed · Last checked
Resolution filing: · SEC filing
Alert me · Calendar: same stage and window-end month (2025-04)
previously treated metastatic colorectal cancer
PDUFA target date (company stated)December 3, 2026
Stage: PDUFASEC filing · “PDUFA) target action date”
Public float: $9,400,000,000 · as of · SEC filing
Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026
SEC filing · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2026-12)
Topline/data readoutSecond Half of 2026
Stage: Phase 3SEC filing · “Phase 3”
Public float: $9,400,000,000 · as of · SEC filing
Topline Results for Phase 3 STELLAR-304 Pivotal Trial Expected in Second Half of 2026
EX-99.1 · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2026-12)
Company periods and sentences are quoted as written. A matching disclosure uses the SEC filing date for the same program and event type. As of .
| Program / event | Stated period and SEC wording | Disclosure in stated period |
|---|---|---|
| zanzalintinibClinical results | Second Half of 2026“Topline Results for Phase 3 STELLAR-304 Pivotal Trial Expected in Second Half of 2026” Filed · EX-99.1 | Still within period As of Oct 19, 2026 |
| zanzalintinib and atezolizumabFDA decision | December 3, 2026“Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| zanzalintinib and atezolizumabFDA decision | December 3, 2026“Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| zanzalintinib and atezolizumabFDA decision | December 3, 2026“Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| zanzalintinib and atezolizumabFDA decision | December 3, 2026“PDUFA target action date of December 3, 2026” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| zanzalintinib and atezolizumabFDA decision | December 3, 2026“target action date of December 3, 2026” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| zanzalintinib and atezolizumabFDA decision | December 3, 2026“Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| zanzalintinib and atezolizumabFDA decision | December 3, 2026“Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| cabozantinibFDA decision | April 3, 2025“Prescription Drug User Fee Act (PDUFA) target action date of April 3, 2025” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| cabozantinibFDA decision | April 3, 2025“PDUFA target action date of April 3, 2025” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| cabozantinibFDA decision | April 3, 2025“Prescription Drug User Fee Act (PDUFA) target action date of April 3, 2025” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| cabozantinibFDA decision | April 3, 2025“PDUFA action date of April 3, 2025” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| cabozantinibAdvisory committee | March 2025“In November 2024, we announced that our sNDA would be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| cabozantinibFDA decision | April 3, 2025“Prescription Drug User Fee Act (PDUFA) target action date of April 3, 2025” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| cabozantinibFDA decision | April 3, 2025“PDUFA target action date of April 3, 2025” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| cabozantinibFDA decision | April 3, 2025“Prescription Drug User Fee Act (PDUFA) target action date of April 3, 2025” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| cabozantinibFDA decision | April 3, 2025“PDUFA target action date of April 3, 2025” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| cabozantinibFDA decision | April 3, 2025“Prescription Drug User Fee Act (PDUFA) target action date of April 3, 2025” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| cabozantinib + atezolizumabSubmission | during the fourth quarter of 2024“We intend to submit an sNDA to the FDA during the fourth quarter of 2024.” Filed · 10-Q | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| cabozantinib + atezolizumabSubmission | in the fourth quarter of 2024“Exelixis intends to submit an sNDA to the FDA for cabozantinib in combination with atezolizumab for mCRPC in the fourth quarter of 2024.” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
“Not compared” means ORION has not matched this wording against a complete set of SEC filings for its period. It says nothing either way about whether a matching filing exists. Wording without exact dates is not given calendar dates.
Historical summaries and source dates are retained separately from the SEC timing quotes above. Earlier publications were collected retrospectively.
Historical catalog checked .
Source published · Original announcement
Retained timing label: 2025-04-03
Retained summary: Exelixis reported FDA review of the supplemental application for previously treated advanced neuroendocrine tumors, with an April 3, 2025 target action date.
Source published · Original announcement
Retained summary: Exelixis announced FDA approval of CABOMETYX for specified previously treated advanced pancreatic and extra-pancreatic neuroendocrine tumors. The approval announcement preceded the published target date.
Original ClinicalTrials.gov record · Open the selected study
These are selected linked records and dated source metadata, not a live registry recheck or the company’s full pipeline. Company announcements and the selected registry study are separate evidence sets. No stage or event timing is borrowed between them.
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See EXEL in the calendar · Review labels and methodology