Rezolute DMC clears ersodetug open-label arm in infants; interim analysis expected Q1 2025

Rezolute, Inc.

DMC reviewed 8 infants (3mo-1yr) on 5/10 mg/kg bi-weekly/monthly: safe, target concentrations reached.
Infants may now enroll in double-blind placebo-controlled portion of sunRIZE Phase 3 study.
Enrollment completion expected Q2 2025 pending interim analysis; topline results Q4 2025 if no change.
Interim analysis end of Q1 2025; three outcomes: futility, continue as is, or increase sample size by 33% (18 pts).
If sample size increased, enrollment shifts to Q4 2025, topline results to mid-2026.

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