Rezolute is a microcap biopharma focused on developing therapies for hypoglycemia caused by hyperinsulinism, with promising late-stage trials for RZ358 and RZ402. RZ358 targets Congenital Hyperinsulinism and Tumor Hyperinsulinism, showing significant efficacy in reducing hypoglycemia in phase 2 trials. Financially, RZLT has a market cap of $279mn, $105mn in cash, and a cash runway of 5–7 quarters, with manageable expenses.
Rezolute rides on robust clinical development activity for lead candidate ersodetug (RZ358) for treating hypoglycemia caused by hyperinsulinism.
Open-label arm (infant participants < 1 year old) has been recently reviewed by a Data Monitoring Committee (DMC) and target drug concentrations were safely reached at tested doses
REDWOOD CITY, Calif., Jan. 31, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, today announced that management will participate in the Guggenheim SMID Cap Biotech Conference, taking place February 5-6, 2025, in New York City.
The FDA bestows an Orphan Drug status to Rezolute's ersodetug for treating hypoglycemia due to tumor hyperinsulinism. Shares rise.
FDA lifts partial clinical holds on ersodetug for the treatment of congenital HI; Phase 3 sunRIZE study to proceed in the U.S.
The FDA removes the partial clinical holds on Rezolute's phase III study evaluating RZ358 for treating congenital hyperinsulinism.
Rezolute Inc said on Monday the U.S. Food and Drug Administration has removed the partial clinical hold on its late-stage study testing its experimental treatment for low blood sugar.
Commencing study startup activities in the U.S.; participant enrollment anticipated in early 2025 Commencing study startup activities in the U.S.; participant enrollment anticipated in early 2025
Second rare disease program with RZ358 in Phase 3 development Follows successful treatment of multiple patients with tumor hyperinsulinism under the Company's Expanded Access Program REDWOOD CITY, Calif., Aug. 05, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious rare diseases, today announced that it received U.S. Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) application for RZ358 (ersodetug) to treat hypoglycemia in patients with tumor hyperinsulinism (HI).