Financing And Dilution RiskPotential need for additional capital to fund late‑stage development raises the risk of shareholder dilution, which could pressure the stock if financing becomes necessary.
Regulatory Approval UncertaintyFDA approval risk remains because regulators in this treatment setting typically prioritize statistically significant overall survival, creating a high bar for approval.
Trial Design And Regional ComplexityThe global design of HARMONi, with substantial participation from China, increases complexity that could complicate interpretation of survival results and draw added regulatory scrutiny.