RZLT - Earnings announcements

Study did not meet the primary or key secondary endpoint  45% reduction in hypoglycemia events observed at top ersodetug dose (10 mg/kg) compared to 40% improvement in placebo arm Management to host conference call today at 8:30am ET REDWOOD CITY, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism, today announced topline results from its Phase 3 sunRIZE study evaluating ersodetug in patients with congenital hyperinsulinism (HI). The study did not meet its primary endpoint, which assessed change in the average weekly hypoglycemia events by self

REDWOOD CITY, Calif., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism, today announced that the company will host a virtual investor event via webcast on Monday, November 10, 2025, from 12:00 – 1:30 pm EST. The event will highlight the market opportunity and clinical development of ersodetug, which is currently being evaluated in two Phase 3 studies in congenital hyperinsulinism (HI) and tumor HI, respectively. During the event, Rezolute Chief Commercial Officer, Sunil Karnawat, will discuss the anticipated commercial opportunities for ersodetug as a p

Phase 3 clinical study of RZ358 underway in patients with congenital hyperinsulinism (cHI); topline results expected in mid-2025 Benefit shown in individual patient cases with RZ358 for tumor-associated hyperinsulinism (taHI) under Expanded Access Program (EAP); drives alignment with FDA on unmet need and potential to move into late-stage clinical development to further evaluate RZ358 in this population REDWOOD CITY, Calif., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced its financial re

REDWOOD CITY, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced its financial results for the first quarter of fiscal 2024 ended September 30, 2023. "We are on track to commence our Phase 3 study for RZ358 to treat congenital hyperinsulinism prior to year-end and are delighted to have recently obtained PRIME eligibility from the European Medicines Agency for this indication," said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. "We also anticipate completing enrollment this quarter for our o

REDWOOD CITY, Calif., Sept. 14, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to disrupt treatment paradigms for devastating metabolic diseases, today announced its financial results for the fourth quarter and full fiscal year ended June 30, 2023. "We are delighted that we are poised to initiate sunRIZE – our Phase 3 study of RZ358, which we hope will bring us one step closer to making this therapy available to patients and their families suffering from congenital hyperinsulinism. We are also anticipating results from our Phase 2 study of RZ402 in the first quarter of 20

Study to be initiated in Europe and other ex-US geographies in Q4 2023, with topline results expected 1H 2025 Conference call scheduled today at 4:30 p.m. ET  REDWOOD CITY, Calif., June 27, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to disrupt current treatment paradigms for devastating metabolic diseases, today provided an update on its clinical development plans for RZ358, the Company's product candidate for congenital hyperinsulinism (congenital HI). Rezolute plans to initiate sunRIZE, a pivotal Phase 3 clinical study of RZ358, in Europe and other geographies outs

REDWOOD CITY, Calif., May 11, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to shift the treatment paradigms of devastating metabolic diseases, today announced its financial results for the third quarter of fiscal 2023 ended March 31, 2023. "We are continuing to make progress across our pipeline, including preparation for a Phase 3 study for RZ358 as well as enrollment of patients in our Phase 2 study for RZ402," said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. "The quarter was punctuated by a Rezolute-hosted virtual key opinion leader event th

REDWOOD CITY, Calif., March 08, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to transform the treatment paradigms of devastating metabolic diseases, will host a virtual event to highlight the Company's RZ402 Phase 2 clinical program and the rationale for an oral plasma kallikrein inhibitor (PKI) in diabetic macular edema (DME) on Wednesday, March 22, 2023, from 4:30 p.m. – 6:00 p.m. EDT. Rezolute management will be joined by Robert Bhisitkul, M.D., Ph.D., a practicing ophthalmologist and retina specialist at The University of California, San Francisco Medical Center. D

Initiated Phase 2 proof-of-concept study of RZ402 Anticipate initiation of global Phase 3 clinical study for RZ358 in mid 2023 REDWOOD CITY, Calif., Feb. 10, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to transform the treatment paradigms of devastating metabolic diseases, today announced its financial results for the second quarter of fiscal 2023 ended December 31, 2022. "The past quarter was marked by steady execution across our pipeline as we continue to advance toward our goal of bringing transformative therapies to patients across the spectrum of metabolic disea

Phase 2 proof-of-concept study of RZ402 expected to be initiated by the end of this year REDWOOD CITY, Calif., Nov. 09, 2022 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to shift the treatment paradigms of devastating metabolic diseases, today announced its financial results for the first quarter of fiscal 2023 ended September 30, 2022. "I am extremely pleased with our progress this year, having reported positive data from both our clinical programs, Phase 1b study of RZ402 for Diabetic Macular Edema and Phase 2b study of RZ358 for Congenital Hyperinsulinism (HI), as well a

REDWOOD CITY, Calif., May 04, 2022 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to disrupt current treatment paradigms for devastating metabolic diseases, today announced that management will be hosting a corporate update call. The call will highlight recent pipeline advancements and continued activities for the development of RZ358 for Congenital Hyperinsulinism and RZ402 for Diabetic Macular Edema. Conference Call and Webcast Information Rezolute management will host a conference call at 4:30 p.m. ET on Wednesday, May 4, 2022. Analysts and investors are invited to partici

Highly significant ~75% reduction in hypoglycemia events at anticipated therapeutic doses≥50% improvement in hypoglycemia in 100% of patients in high-dose cohort, with no adverse drug reactions or clinically significant hyperglycemiaStudy exceeded expectations for correction of hypoglycemia across multiple metrics, including hypoglycemia events and time in hypoglycemiaPredictable and dose-dependent exposures with a clear dose-responseGood safety and tolerability across all doses with no study discontinuations or adverse drug reactions Results are Phase 3 enabling and demonstrate the potential for RZ358 to be used as a monotherapy as well as a potential universal therapy for all forms of hype

Rezolute to host conference call presentation and discussion of the data on Sunday, May 1 at 2:30 p.m. ET REDWOOD CITY, Calif., April 26, 2022 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to disrupt current treatment paradigms for devastating metabolic diseases, today announced a late-breaking oral presentation of its Phase 2b RIZE Study Topline Data of RZ358 in congenital hyperinsulinism (HI) at the upcoming Pediatric Endocrine Society 2022 Annual Meeting on May 1, 2022. On behalf of the Company and the study co-authors, Dr. Paul Thornton, a pediatric endocrinologist, and

The RIZE study demonstrated highly significant improvements in hypoglycemia and good safety and tolerability Results to be presented in an oral presentation at a medical congress in 2Q 2022 REDWOOD CITY, Calif., March 23, 2022 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to disrupt current treatment paradigms for devastating metabolic diseases, today announced positive data from its Phase 2b RIZE study of RZ358. The data demonstrated the safety and tolerability of RZ358 in patients with congenital hyperinsulinism, as well as highly significant improvements in hypoglycemia.

REDWOOD CITY, Calif., Sept. 15, 2021 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company developing transformative therapies for metabolic diseases associated with chronic glucose imbalance, today announced its financial results for the fourth quarter and fiscal full year ended June 30, 2021. "We are very pleased with our overall progress, notably advancement of our clinical programs including RZ358 for congenital hyperinsulinism and RZ402 for diabetic macular edema," said Nevan Elam, Chief Executive Officer and Founder of Rezolute. "We have continued to execute on the milestones we laid out prior to the COVID-19 pandemic, including the initiation

REDWOOD CITY, Calif., May 17, 2021 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company developing transformative therapies for metabolic diseases associated with chronic glucose imbalance, today announced its financial results for the fiscal third quarter ended March 31, 2021. "We continue to advance the clinical development of our pipeline candidates, RZ358 and RZ402, with several milestones expected this year," said Nevan Elam, Chief Executive Officer of Rezolute. "Highly encouraging topline results from our Phase 1 study of RZ402 support oral daily dosing for the treatment of diabetic macular edema, and we are on track to initiate a repeat-dose

REDWOOD CITY, Calif., Feb. 10, 2021 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), today announced its financial results for the quarter ended December 31, 2020. Recent Business Highlights Phase 2b study of RZ358 continues to enroll congenital hyperinsulinism (HI) patients worldwide – The RIZE Phase 2b study of RZ358 for the treatment of congenital HI continues to enroll patients, with study completion expected in the second half of 2021. RZ358 is an allosteric modulator of the insulin receptor being developed as a treatment for all forms of congenital HI.Initiation of Phase 1 study of RZ402 – In January 2021, Rezolute announced initiation of dosing in a Phase 1 clinical study of ora