Ivonescimab OS Benefit Strengthens in Western Patients, Hazard Ratio Hits 0.76 Ahead of FDA Decision
SMMT sits 16% above its 52-week low of $12.55.
Summary
Updated Phase III HARMONi data show ivonescimab's overall survival benefit now consistent across Western and Asian patients, with the Western subgroup hazard ratio improving to 0.76 as follow-up matures to 23.2 months. This closes the gap seen in earlier analyses where Western patients showed less benefit, strengthening the case for FDA approval. The data have been submitted to the FDA ahead of the November 14, 2026 PDUFA date. The consistent efficacy across geographies reduces a key regulatory risk and supports the drug's global commercial potential. This follows the June 2026 data cut-off and builds on the positive PFS results that formed the BLA basis.
At the time of this announcement, SMMT was trading at $14.52 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $11.4B. The 52-week trading range was $12.55 to $30.98. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: BusinessWire.