Clinical SuccessManagement expects to see a ≥35% placebo-adjusted change in hypoglycemic events in sunRIZE, with high odds of being met or exceeded, considering previous results showed a 74% reduction in hypoglycemic events.
Market PotentialErsodetug is expected to reach more than 50% of the approximately 3,000 prevalent patient population at peak.
Regulatory AlignmentThe F1Q26 update reaffirmed an alignment between RZLT and the FDA that the Ph3 sunRIZE study of ersodetug in congenital hyperinsulinism (HI) meets registrational requirements for BLA filing and review.