Clinical TrialsThe ongoing Ph3 sunRIZE study of ersodetug in congenital hyperinsulinism will continue as planned with no need to increase sample size based on the DMC's recommendation following a pre-specified interim analysis.
Efficacy And SafetyApproval for infant patient enrollment confirms ersodetug's safety, which is important as the age range represents the most dynamic phase of the disease.
Regulatory ApprovalRZLT has reached an alignment with the FDA on moving directly into a Ph3 registrational study based on positive data from an active expanded access program.