Rezolute shares surge 10.01% premarket after FDA encourages submission of sunRIZE data for congenital HI drug.

Rezolute surged 10.01% in premarket trading following a constructive FDA meeting regarding its Phase 3 sunRIZE trial for ersodetug, a treatment for congenital hyperinsulinism. Despite the trial missing its primary endpoint due to behavioral factors influencing self-monitored glucose data, the FDA encouraged the company to submit comprehensive study reports and analysis datasets for independent evaluation. The agency acknowledged the challenges in measuring hypoglycemia in this patient population and expressed interest in reviewing CGM-based glycemic endpoints and open-label extension data. This feedback signals a potential pathway for regulatory submission, reinforcing investor optimism about the drug’s development. The CEO highlighted the FDA’s engagement and openness to a thorough review, suggesting a constructive regulatory relationship. The stock’s sharp rise reflects renewed hope for advancing ersodetug despite the trial’s initial limitations.