Pivotal Trial FailureFailure of a late-stage pivotal trial to meet its primary endpoint significantly increases doubt about the drug's chance of regulatory approval for the targeted skin disease.
Placebo Response UncertaintyA higher-than-expected placebo response in a pivotal study prevented statistical significance under the original analysis method, raising questions about that trial's contribution to a marketing application.
Valuation And Dilution RiskAnalyst reductions in probability of success and lowered peak market penetration, together with equity dilution and higher projected operating expenses, have pressured the stock's valuation and potential upside.