Clinical Trial RiskA pivotal study failed to meet its primary effectiveness endpoint, creating uncertainty around regulatory approval prospects and clinician confidence in the indication.
Data Consistency ConcernsMissed primary endpoints at intermediate assessments, despite some later improvements on secondary measures, introduce inconsistency that could complicate regulatory review and adoption by physicians.
Distribution And Revenue RiskDecision not to renew the distribution agreement with a commercial partner reduces near‑term revenue visibility and may disrupt established sales channels, pressuring short‑term financial performance.