HUTCHMED, AstraZeneca File FDA NDA for ORPATHYS-TAGRISSO Combo in Resistant NSCLC; HCM Jumps 2%

HUTCHMED (HCM) said AstraZeneca (AZN) submitted a New Drug Application to the U.S. FDA for ORPATHYS plus TAGRISSO in advanced non-small cell lung cancer that progressed after prior EGFR-targeted therapy. HCM rose 2.05% to $14.42 in after-hours trading on September 28, 2026, after closing up 1.36% at $14.13. The all-oral combination targets locally advanced or metastatic EGFR-mutated NSCLC with MET overexpression or amplification that has progressed on or after EGFR tyrosine kinase inhibitor therapy. The NDA is backed by the Phase 3 SAFFRON trial, which showed statistically significant improvements in progression-free and overall survival versus platinum-based doublet chemotherapy, with no new safety concerns. ORPATHYS, jointly developed by HUTCHMED and AstraZeneca, is already approved in China on Phase 3 SACHI data. Full SAFFRON results are due at ESMO Congress 2026. The FDA will decide whether to accept the filing for formal review.