Competitive Threat From InjectablesMarket uptake could be constrained by long-acting injectable therapies that may be perceived by patients and physicians as offering greater convenience than continuous oral treatment.
Data TransparencyLimited data disclosure leaves questions about durability of deep responses, trial-to-trial consistency, and handling of missing data, increasing uncertainty for investors and regulators.
Development And Approval RiskRisks include potential delays in advancing the program into pivotal trials and failure to secure approval in major markets if key efficacy areas are not achieved.