Catalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Zanzalintinib + atezolizumab in Metastatic colorectal cancer. The expected timing is based on the latest available company guidance and may change.
STELLAR-303 trial. 8/6/24- Enrollment completed. 6/22/25- Topline results reported. 10/20/25- Detailed results presented at ESMO'25. Complete first NDA submission in 2025. 01/07/26:- NDA submitted for zanzalintinib plus atezolizumab in mCRC; STELLAR-303 OS NLM final analysis expected Mid-2026.01/30/26:- NDA accepted for mCRC; PDUFA action date December 3, 2026. STELLAR-303 OS NLM final analysis expected Mid-2026.05/21/26:- ASCO 2026 STELLAR-303 analysis May 30; PDUFA action date remains December 3, 2026. 06/21/26:- Final NLM OS analysis showed HR 0.83. PDUFA remains December 3, 2026. Conference submission planned.
Verification
Confirm timing and program details against the company announcement or filing.