Rezolute sunRIZE Phase 3 misses primary endpoint; CGM analyses show nominal hypoglycemia reduction

Rezolute, Inc.

Primary endpoint (hypoglycemia events by SMBG) not met; secondary CGM endpoint not statistically significant at Week 24/EOT.
CGM analyses showed nominal significance: >50% reduction in time-in-hypoglycemia (FAS), ~60-80% (PPS) vs placebo across timepoints.
OLE: all 59 completers enrolled, 57 continue; up to 24 months exposure; reduced background SOC, many on ersodetug monotherapy.
FDA Type B meeting (Mar 17, 2026) acknowledged primary endpoint challenges; requested comprehensive data submission to inform next steps.
Company believes data show target engagement and therapeutic potential; seeking alignment with FDA on path to approval.

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