Rezolute (RZLT) gets FDA Breakthrough Therapy Designation for ersodetug in congenital hyperinsulinism

Rezolute, Inc.

FDA granted Breakthrough Therapy Designation to ersodetug (RZ358) for hypoglycemia due to congenital hyperinsulinism.
Designation based on Phase 2b (RIZE) study: ≥75% reduction in hypoglycemia, no clinically significant hyperglycemia.
Topline results from Phase 3 sunRIZE study expected H2 2025; U.S. sites enrolling after partial clinical hold lifted.
Company raised $73M in June 2024, extending cash runway into Q2 2026 to support clinical programs.
Also received ODD and IND clearance for tumor HI Phase 3 study, with topline results expected H2 2026.

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