Core Viewpoint - Rezolute, Inc. has received Orphan Drug Designation from the FDA for its lead candidate, ersodetug, aimed at treating hypoglycemia caused by tumor hyperinsulinism, a rare disease [1][2]. Company Developments - Following the FDA announcement, shares of Rezolute increased by nearly 5% on December 3 [2]. - Year-to-date, Rezolute's shares have surged by 439.1%, contrasting with a 7% decline in the industry [3]. - The FDA previously cleared Rezolute's investigational new drug application for ersodetug in August, and the company is preparing for a phase III registrational study [4]. - Patient enrollment for the phase III study is expected to start in the first half of 2025, with top-line data anticipated in the second half of 2026 [5]. Additional Research and Studies - Rezolute is also developing ersodetug for congenital hyperinsulinism, an ultra-rare pediatric genetic disorder, with the FDA lifting partial clinical holds on the phase III sunRIZE study in September [6]. - Enrollment for the sunRIZE study is expected to begin in early 2025, with topline data expected in the second half of 2025 [7]. - The sunRIZE study was initiated in December 2023 [8].
RZLT Stock Rises on FDA's Orphan Designation for Rare Disease Drug