Rezolute, Inc., a clinical stage biopharmaceutical company, develops transformative therapies for metabolic diseases associated with chronic glucose imbalance in the United States. The company's lead product candidate is RZ358, a human monoclonal antibody that is in Phase 2b clinical trial for the treatment of congenital hyperinsulinism, an ultra-rare pediatric genetic disorder. It is also developing RZ402, a selective and potent plasma kallikrein inhibitor, which is in Phase 1 clinical trial for the chronic treatment of diabetic macular edema. The company was formerly known as AntriaBio, Inc. and changed its name to Rezolute, Inc. in December 2017. Rezolute, Inc. was founded in 2010 and is headquartered in Redwood City, California.
IPO Year:
Exchange: NASDAQ
Website: rezolutebio.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 11/5/2024 | $12.00 | Outperform | Wedbush |
| 8/27/2024 | $11.00 | Buy | Guggenheim |
| 7/17/2024 | $13.00 | Buy | BTIG Research |
| 6/4/2024 | $14.00 | Buy | Craig Hallum |
| 4/9/2024 | $8.00 | Buy | Maxim Group |
| 8/2/2022 | $17.00 | Buy | Canaccord Genuity |
| 6/15/2022 | $9.00 | Overweight | Cantor Fitzgerald |
| 11/29/2021 | $30.00 → $17.00 | Buy | Canaccord Genuity |
| 11/15/2021 | $30.00 → $18.00 | Market Outperform | JMP Securities |
| 9/8/2021 | $21.00 | Buy | ROTH Capital |
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Target enrollment exceeded with 62 participants enrolled, including approximately 15 percent from U.S. sites Topline data is anticipated in December of 2025 REDWOOD CITY, Calif., May 28, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI), today announced that enrollment is complete in the sunRIZE study, a global, Phase 3 multicenter, double-blind, randomized, placebo-controlled, parallel arm study designed to evaluate the efficacy and safety of ersodetug for the treatment of hypoglycemia in patients with congenital HI. "The completion of enrollment in the s
sunRIZE enrollment on track including U.S. sites and expected to be completed in May 2025; topline data anticipated in December 2025 U.S. Food and Drug Administration (FDA) grants Breakthrough Therapy Designation to ersodetug for hypoglycemia due to tumor hyperinsulinism REDWOOD CITY, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI), today reported financial results and provided a business update for the three months ended March 31, 2025. "The Phase 3 sunRIZE study in congenital HI is on track to complete enrollment this month and we are p
Registrational study in patients with tumor hyperinsulinism (HI) expected to commence mid-year Designation underscores need for therapies to treat severe hypoglycemia in the oncology setting REDWOOD CITY, Calif., May 05, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by HI, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to its investigational therapy, ersodetug, for the treatment of hypoglycemia caused by tumor HI. BTD for ersodetug was granted based on clinical trial data across the overall program and a re
REDWOOD CITY, Calif., May 01, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism, today announced that management will participate in the following investor conferences: Event: The Citizens JMP Life Sciences Conference Date: May 7-8, 2025 Event: H.C. Wainwright BioConnect Investor Conference Date: May 20, 2025 Event: Craig-Hallum Institutional Investor Conference Date: May 28, 2025 Event: Jefferies Global Healthcare Conference Date: June 3-5, 2025 Management will be participating in one-on-one investor meetings thro
NEW YORK, April 25, 2025 (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 the closing of its previously announced underwritten offering (the "Offering") of an aggregate of 24,940,769 shares of its common stock at an offering price of $3.25 per share, which includes 4,153,846 shares of common stock pursuant to the exercise in full of the underwriters' option to purchase additional shares of common stock and, to certain investors in lieu of common stock, pre-funded warrants to purchase up to 6,905,385 shares of common stock a
NEW YORK, April 23, 2025 (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 the pricing of an underwritten offering, priced at-the-market under Nasdaq rules, of an aggregate of 20,786,923 shares of its common stock at an offering price of $3.25 per share, and, to certain investors in lieu of common stock, pre-funded warrants to purchase up to 6,905,385 shares of common stock at an offering price of $3.2490 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.001 per share exer
Independent Data Monitoring Committee (the "DMC") recommends continuation of sunRIZE trial as planned with no need to increase sample size Enrollment on track and expected to be completed in May 2025; topline data anticipated in December 2025 U.S. sites activated and enrolling patients REDWOOD CITY, Calif., April 23, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) (the "Company or "Rezolute"), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, today announced the DMC's recommendation to continue the Phase 3 sunRIZE study as planned in patients with congenital HI, without an increase in the study samp
REDWOOD CITY, Calif., March 26, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, announced the appointment of Erik Harris to its Board of Directors, effective immediately. Mr. Harris, who currently serves as Chief Commercial Officer and Executive Vice President at Ultragenyx, brings more than 20 years of biopharmaceutical expertise to Rezolute. "We are thrilled to welcome Erik to our board. He is a recognized rare disease commercial expert, and his insights will be invaluable as we advance our lead programs through clinical development and prepare for p
Ersodetug, a novel, fully human monoclonal antibody for the treatment of hyperinsulinism (HI), receives Breakthrough Therapy Designation and Orphan Drug Designation Open-label arm (infant participants < 1 year old) of the sunRIZE study has been reviewed by a Data Monitoring Committee (DMC); target drug concentrations were safely reached at tested doses and infants are approved for enrollment into the double-blind portion of the study REDWOOD CITY, Calif., Feb. 12, 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 repo
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 DMC approved enrollment of infants into the double-blind portion of the study sunRIZE enrollment completion expected in Q2 2025, subject to outcomes from upcoming interim analysis REDWOOD CITY, Calif., Feb. 04, 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 outcomes from an independent Data Monitoring Committee (DMC) review o
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sunRIZE enrollment on track including U.S. sites and expected to be completed in May 2025; topline data anticipated in December 2025 U.S. Food and Drug Administration (FDA) grants Breakthrough Therapy Designation to ersodetug for hypoglycemia due to tumor hyperinsulinism REDWOOD CITY, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI), today reported financial results and provided a business update for the three months ended March 31, 2025. "The Phase 3 sunRIZE study in congenital HI is on track to complete enrollment this month and we are p
REDWOOD CITY, Calif., March 26, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, announced the appointment of Erik Harris to its Board of Directors, effective immediately. Mr. Harris, who currently serves as Chief Commercial Officer and Executive Vice President at Ultragenyx, brings more than 20 years of biopharmaceutical expertise to Rezolute. "We are thrilled to welcome Erik to our board. He is a recognized rare disease commercial expert, and his insights will be invaluable as we advance our lead programs through clinical development and prepare for p
REDWOOD CITY, Calif., Jan. 24, 2024 (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 the addition of Daron Evans, MS, MBA, to its leadership team as Chief Financial Officer as well as the grant of share options as a material inducement for his appointment (the "Inducement Grant"). About Mr. Evans "This is a pivotal year for Rezolute as we initiated our Phase 3 clinical study for RZ358 in congenital hyperinsulinism and anticipate reporting topline data from our Phase 2 study for RZ402 in diabetic macular edema in the secon
REDWOOD CITY, Calif., Aug. 10, 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 that the Company has initiated dosing in a Phase 1b multiple-ascending dose study of RZ402, Rezolute's investigational oral plasma kallikrein inhibitor (PKI) for the treatment of diabetic macular edema (DME). Rezolute also announced the appointment of ophthalmology expert and key opinion leader, Dr. Rajat Agrawal, MD, MS, as Vice President, Clinical Development to lead the RZ402 clinical development program. "The Phase 1b study will evaluate the
REDWOOD CITY, Calif., May 20, 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 the addition of Davelyn Hood, MD, to its leadership team as Director, Scientific and Patient Affairs. In her new role, Dr. Hood will be a key member of the team in furthering the development of RZ358, Rezolute's monoclonal antibody currently being evaluated in a Phase 2b clinical trial to treat congenital hyperinsulinism, a rare disease that is the most common cause of persistent low blood sugars in children. "Dr. Hood is an ideal addition to our
REDWOOD CITY, Calif., May 18, 2021 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company developing novel therapies for diseases related to chronic glucose imbalance, today announced the addition of Quan Dong Nguyen, MD, MSc, FAAO, FARVO to its Scientific Advisory Board. Dr. Nguyen is a renowned expert in retinal vascular and uveitic diseases and is expected to provide valuable strategic and scientific counsel related to RZ402, the Company's investigational oral plasma kallikrein inhibitor (PKI), for the treatment of diabetic macular edema (DME). "Dr. Quan Dong Nguyen has a distinguished track record of innovative research leading to new treatments f
REDWOOD CITY, Calif., Dec. 28, 2020 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq:RZLT), focused on advancing therapies for rare, metabolic and life-threatening diseases, announced today the appointment of IssuerDirect as the Company’s registrar and transfer agent and shareholder support provider. IssuerDirect will now be responsible for all transfers of Rezolute shares rather than VStock Transfer, LLC. Shareholders need take no action related to this transaction. About Rezolute, Inc.Rezolute is advancing targeted therapies for rare, metabolic, and life-threatening diseases. Its lead clinical asset, RZ358, is in Phase 2b development as a potential treatment for congenital HI, a rare pediatri
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Wedbush initiated coverage of Rezolute with a rating of Outperform and set a new price target of $12.00
Guggenheim initiated coverage of Rezolute with a rating of Buy and set a new price target of $11.00
BTIG Research initiated coverage of Rezolute with a rating of Buy and set a new price target of $13.00
Craig Hallum initiated coverage of Rezolute with a rating of Buy and set a new price target of $14.00
Maxim Group initiated coverage of Rezolute with a rating of Buy and set a new price target of $8.00
Canaccord Genuity resumed coverage of Rezolute with a rating of Buy and set a new price target of $17.00
Cantor Fitzgerald initiated coverage of Rezolute with a rating of Overweight and set a new price target of $9.00
Canaccord Genuity reiterated coverage of Rezolute with a rating of Buy and set a new price target of $17.00 from $30.00 previously
JMP Securities reiterated coverage of Rezolute with a rating of Market Outperform and set a new price target of $18.00 from $30.00 previously
ROTH Capital initiated coverage of Rezolute with a rating of Buy and set a new price target of $21.00
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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