Clinical Trial ResultsThe results did not offset concerns about the death in the trial from sepsis, which was disclosed in a footnote to the AE table.
FDA Approval RisksRisks include potential inability to generate further favorable clinical data, failure to secure accelerated FDA approval, and possible poorer market uptake due to competition or other factors.
Safety ConcernsShares were pressured, closing down approx. -32%, reflecting some investor concerns about safety following the disclosure of the death of a patient with a Grade 5 serious adverse event from pancytopenia and sepsis.