Approval Risk Tied To Survival DataU.S. approval remains uncertain because regulators commonly expect statistically significant overall survival benefits in this treatment setting, keeping approval risk elevated.
Clinical Delays And Financing PressurePotential delays or failures in ivonescimab studies combined with the risk of future capital raises could create operational setbacks and lead to shareholder dilution.
Trial Design And InterpretabilityThe global HARMONi trial structure, including heavy participation from China, increases complexity and could raise regulatory scrutiny around trial conduct and the interpretation of survival results.