Intellectual Property And CompetitionMultiple generic challenges to the key dosing patent and the approval of a rival lupus nephritis therapy threaten long-term exclusivity and could erode future Lupkynis sales.
Regulatory Pathway UncertaintyUnresolved alignment with regulators on registrational trial design, together with a cancelled regulatory meeting that prompted management to pursue strategic alternatives, creates uncertainty about the path to approval and near-term strategy.
Safety And Clinical RiskFatal events reported in a clinical trial raise significant safety and regulatory risk, which could impede development timelines, complicate approvals, and weigh on investor sentiment.