Exelixis plans an NDA submission for zanzalintinib after detailed Stellar‑303 Phase III results showed an overall survival benefit when the oral TKI was combined with atezolizumab versus regorafenib in previously treated metastatic colorectal cancer. The company reported a consistent survival signal across subgroups and is preparing regulatory filings as described in Lancet and ESMO presentations. In parallel, Celcuity released Viktoria‑1 data positioning gedatolisib, a pan‑PI3K/mTOR inhibitor, as a top second‑line option for HR+/HER2‑, PIK3CA‑wildtype advanced breast cancer and said it would complete a rolling NDA by year‑end. Both developments reflect incremental regulatory momentum for targeted agents in crowded oncology markets and will drive next‑phase commercial planning and competitive positioning.