Rezolute
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2010-01-01
- Employees
- 51
- Market Cap
- $265.1M
- Website
- http://www.rezolutebio.com
- Introduction
Rezolute, Inc. operates as a biopharmaceutical company, which engages in the development of drug therapies for patients with metabolic and orphan diseases. Its clinical assets include Ersodetug, a potential treatment for hypoglycemia caused by multiple forms of hyperinsulinism, and RZ402, an oral plasma kallikrein inhibitor and potential therapy for the chronic treatment of diabetic macular edema. The company was founded by Nevan Charles Elam, Ho Young Huh, and Sankaram Mantripragada on July 26, 2010 and is headquartered in Redwood City, CA.
Rezolute Reports Fourth Quarter and Full Year Fiscal 2024 Financial Results and Provides
FDA lifts partial clinical holds on ersodetug for congenital HI; Phase 3 sunRIZE study to proceed in the U.S. Phase 3 study for tumor HI expected to start in H1 2025.
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FDA lifts partial clinical hold on phase 3 low blood sugar treatment
The FDA lifted the partial clinical hold on Rezolute's esodetug after a follow-up toxicology study showed no liver issues, tracing previous toxicity to a specific rat strain. Esodetug, a monoclonal antibody for congenital hyperinsulinism, is in phase 3 trials globally, with U.S. enrollment starting in early 2025. Rezolute's CEO expressed delight at the FDA's decision, allowing the study to proceed in the U.S. at all doses for patients as young as three months.
Partial ban on phase 3 low blood sugar treatment study lifted
Rezolute's esodetug, a treatment for congenital hyperinsulinism, had a partial clinical hold lifted by the FDA after a follow-up study showed no liver toxicity in rats, differing from earlier findings. The drug, in phase 3 trials, corrects low blood sugar by binding to insulin receptors. Rezolute plans U.S. phase 3 trials starting 2025, with results expected late 2025.
FDA authorises US trial of Rezolute's drug candidate for congenital hyperinsulinism
FDA lifts partial clinical holds on Rezolute’s RZ358, allowing US inclusion in Phase III trial for congenital hyperinsulinism-induced hypoglycaemia. The sunRIZE study aims to enrol 56 patients aged 3 months to 45 years with poorly controlled hypoglycaemia. Enrollment in the US is set to begin early next year, with topline data expected in H2.
Rezolute's RZ358 Advances with FDA Clearance for Study
Rezolute (RZLT) announces FDA removes all partial clinical holds on RZ358, their therapy for hypoglycemia caused by congenital hyperinsulinism, enabling U.S. participants in the global Phase 3 sunRIZE study. Enrollment expected in early 2025, with top-line data anticipated in the latter half of the year.
FDA Lifts Partial Clinical Holds on RZ358 for the Treatment of Congenital Hyperinsulinism
FDA lifts partial clinical holds on Rezolute's RZ358 for congenital hyperinsulinism, allowing U.S. inclusion in ongoing Phase 3 sunRIZE study. U.S. enrollment planned for early 2025, with topline data expected in second half of 2025. FDA concludes liver toxicity in rats likely strain-specific and not relevant to humans.
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