Rezolute provides FDA meeting update after Phase 3 HI trial missed primary endpoint

Rezolute, Inc.

sunRIZE Phase 3 ersodetug trial missed primary endpoint (SMBG hypoglycemia reduction); FDA acknowledged behavioral confounders.
FDA encouraged submission of study reports and analysis datasets for independent evaluation; company expects update in H2 2026.
Preliminary open-label extension data show continued glycemic improvement and reduction of background therapies.
Company believes FDA did not dismiss program; outcomes to be presented at upcoming scientific conference.

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