Comparative Clinical CompetitivenessA lower overall response rate versus a leading competitor and continued tolerability concerns may hinder the drug's ability to fully displace established therapies in key indications.
Emerging Late-stage CompetitionInvestor concern about a rival program entering late-stage development for second-line GIST raises the risk of future competition that could pressure pricing, market share, and commercial forecasts.
Safety Profile And MonitoringTransient but serious liver enzyme elevations and a higher rate of adverse events relative to some comparators increase the likelihood of post-approval safety monitoring, dose modifications, or label restrictions that could limit uptake.