Financial And Dilution RiskRezolute has no product revenue and is likely to need additional capital, creating potential dilution and financial uncertainty for shareholders.
Phase 3 Efficacy UncertaintyThe Phase 3 sunRIZE study failed to meet its primary and key secondary endpoints by continuous glucose monitoring, raising questions about reproducible clinical benefit compared with earlier data.
Placebo Effect And Monitoring IntensityA high placebo response, likely driven by intensive glucose monitoring and frequent clinical interactions, complicates interpretation of trial outcomes and may obscure the drug's true effect.