RIZE

Rezolute Receives Priority Medicines (PRIME) Eligibility from European Medicines Agency for Enhanced Regulatory Support of RZ358 in Congenital Hyperinsulinism

Retrieved on: 
Tuesday, October 17, 2023
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REDWOOD CITY, Calif., Oct. 17, 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 that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) eligibility to RZ358 for the treatment of congenital hyperinsulinism (HI).

Key Points: 
  • REDWOOD CITY, Calif., Oct. 17, 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 that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) eligibility to RZ358 for the treatment of congenital hyperinsulinism (HI).
  • PRIME eligibility is granted by EMA to drug candidates that target an unmet medical need and show potential benefit for patients based on clinical trial results.
  • The PRIME initiative was created to provide proactive and enhanced support to developers of promising medicines to optimize development plans and accelerate evaluation with the goal of having new therapies reach patients faster.
  • “We are excited to receive PRIME eligibility for RZ358, especially as we plan to initiate our Phase 3 study for RZ358 this quarter,” remarked Susan Stewart, JD, Chief Regulatory Officer at Rezolute.

Rezolute Reports Full Year Fiscal 2023 Results and Highlights Company Progress

Retrieved on: 
Thursday, September 14, 2023
DME, RIZE, Sunrize Band, Pharmacokinetics, G&A, Diabetic retinopathy, Trial of the century, Hypoglycemia, DSM-IV codes, Patient, Investment, R, Research, Safety, Congenital hyperinsulinism, Pharmaceutical industry, Coal, Rezolution Pictures

Full fiscal year 2023 R&D expenses were $43.8 million, compared to $32.5 million in fiscal year 2022.

Key Points: 
  • Full fiscal year 2023 R&D expenses were $43.8 million, compared to $32.5 million in fiscal year 2022.
  • Full fiscal year 2023 G&A expenses were $12.2 million, compared to $9.4 million in fiscal year 2022.
  • Net loss was $12.7 million for the fourth quarter of fiscal 2023, compared to $9.4 million for the same period in fiscal 2022.
  • Full year fiscal 2023 net loss was $51.8 million compared to net loss of $41.1 million for the fiscal year 2022.

Rezolute to Initiate a Pivotal Phase 3 Study of RZ358 in Participants 3 Months of Age and Older with Congenital Hyperinsulinism

Retrieved on: 
Tuesday, June 27, 2023
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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 outside the US in Q4 2023, with topline results anticipated in the first half of 2025. The sunRIZE study is a randomized, double-blind, placebo-controlled, parallel arm evaluation of RZ358 in participants with congenital HI who are not adequately responding to standard of care medical therapies. The Phase 3 study follows the Company’s successful Phase 2b RIZE study which demonstrated that RZ358 was generally safe and well-tolerated, as well as effective in improving hypoglycemia in participants who were failing available medical therapies.

Key Points: 
  • Rezolute plans to initiate sunRIZE, a pivotal Phase 3 clinical study of RZ358, in Europe and other geographies outside the US in Q4 2023, with topline results anticipated in the first half of 2025.
  • The sunRIZE study is a randomized, double-blind, placebo-controlled, parallel arm evaluation of RZ358 in participants with congenital HI who are not adequately responding to standard of care medical therapies.
  • The Phase 3 study follows the Company’s successful Phase 2b RIZE study which demonstrated that RZ358 was generally safe and well-tolerated, as well as effective in improving hypoglycemia in participants who were failing available medical therapies.
  • The live audio webcast of the call will be available under "Events" in the Investor section of the Company's website at https://ir.rezolutebio.com/news-events/ir-calendar .

L’Oréal Fund for Nature Regeneration accelerates biodiversity preservation efforts with three new investments

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Thursday, April 20, 2023
Acceleration, Intergovernmental Panel on Climate Change, RIZE, Tree, Climate change, Carbon, Forest, Amazon, Biodiversity, EUR, Mangrove, Regeneration, Afforestation, IPCC, Soil, Non-governmental organization, Natixis Investment Managers, Clichy, ARR, NetZero, Environment, CO2, Seaweed, Agriculture

Clichy, 20th April 2023 – Ahead of Earth Day, L’Oréal today announced three new recipients of its Fund for Nature Regeneration.

Key Points: 
  • Clichy, 20th April 2023 – Ahead of Earth Day, L’Oréal today announced three new recipients of its Fund for Nature Regeneration.
  • With the Intergovernmental Panel on Climate Change (IPCC) calling for more global cooperation in biodiversity preservation efforts2, L’Oréal is accelerating its longstanding commitment to biodiversity beyond its own value chain.
  • “The L’Oréal Fund for Nature Regeneration is an important vehicle in our efforts towards a more sustainable future for all.
  • “The L’Oréal Fund for Nature Regeneration is a catalyst for sustainable value creation through private capital, enabling the acceleration of environmental solutions with long-term benefit.

Sun Life and DentaQuest donate $100,000 to RIZE Massachusetts

Retrieved on: 
Wednesday, March 8, 2023
American Diabetes Association, National Alliance, Sun Life Financial, United States House Ways and Means Subcommittee on Health, Massachusetts Department of Public Health, Friends, Health, RIZE, Tooth fairy, Research, Kansas City metropolitan area, Dental care, Opioid, Black Alliance for Educational Options, National Alliance on Mental Illness, Face, Breakfast, Quality of life, Employment, Dentistry, Bay, Mental disorder, Death, Mental health, Diabetes, Courage, Public health, Mental, Organization, Greater Boston, Health equity, Family, YMCA, Hospital, Pharmaceutical industry, Nursing

WELLESLEY, Mass., March 8, 2023 /PRNewswire/ -- Sun Life U.S. and DentaQuest, part of Sun Life U.S., have donated $100,000 to RIZE Massachusetts, an independent nonprofit foundation solely dedicated to funding and creating solutions to end the opioid crisis.

Key Points: 
  • WELLESLEY, Mass., March 8, 2023 /PRNewswire/ -- Sun Life U.S. and DentaQuest, part of Sun Life U.S., have donated $100,000 to RIZE Massachusetts , an independent nonprofit foundation solely dedicated to funding and creating solutions to end the opioid crisis.
  • DentaQuest President and RIZE Board Chair Steve Pollock served as co-host of the event.
  • "DentaQuest and Sun Life support RIZE because we share a commitment to advancing health equity, which starts by expanding access to care and benefits, particularly for underserved populations.
  • "RIZE is grateful to receive this incredible gift from Sun Life and DentaQuest, which will help further our mission to end the overdose crisis in Massachusetts and improve quality of life for people with substance use disorders," said Julie Burns, president and CEO of RIZE Massachusetts Foundation.

Rezolute Reports First Quarter Fiscal 2023 Results and Highlights Company Progress

Retrieved on: 
Wednesday, November 9, 2022
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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.

Key Points: 
  • Research and development (R&D) expenses were $7.7 million for the first quarter of fiscal 2023, compared to $5.8 million for the same period in fiscal 2022.
  • General and administrative (G&A) expenses were $2.5 million for the first quarter of fiscal 2023, compared to $1.9 million for the same period in fiscal 2022.
  • Net loss was $9.8 million for the first quarter of fiscal 2023, compared to $7.8 million for the same period in fiscal 2022.
  • Rezolute is also developing RZ402, an orally available plasma kallikrein inhibitor, for the treatment of diabetic macular edema.

Rezolute Reports Fourth Quarter and Full Year Fiscal 2022 Results and Highlights Company Progress

Retrieved on: 
Thursday, September 15, 2022
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REDWOOD CITY, Calif., Sept. 15, 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 fourth quarter and full fiscal year ended June 30, 2022.

Key Points: 
  • Research and development (R&D) expenses were $8.6 million for the fourth quarter of fiscal 2022, compared to $4.4 million for the same period in fiscal 2021.
  • General and administrative (G&A) expenses were $2.7 million for the fourth quarter of fiscal 2022, compared to $2.2 million for the same period in fiscal 2021.
  • Net loss was $9.4 million for the fourth quarter of fiscal 2022, compared to $6.5 million for the same period in fiscal 2021.
  • Full year fiscal 2022 net loss was $41.1 million compared to net loss of $20.9 million for the fiscal year 2021.

Rezolute Announces Presentation at the 60th Annual ESPE Meeting

Retrieved on: 
Wednesday, September 7, 2022
Congenital hyperinsulinism, Patient, Securities Exchange Act of 1934, ESPE, Securities Act of 1933, Lists of diseases, Rezolution Pictures, RIZE, Diabetic retinopathy, GLOBE, Nasdaq, Company, Twitter, Private Securities Litigation Reform Act, Forward-looking statement, Pharmaceutical industry

REDWOOD CITY, Calif., Sept. 07, 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 it will present additional data from its Phase 2b RIZE Study of RZ358 in congenital hyperinsulinism (HI) in an oral presentation at the 60th European Society for Paediatric Endocrinology (ESPE) meeting being held September 15-17, 2022 in Rome, Italy.

Key Points: 
  • Its novel therapies hold the potential to both significantly improve outcomes and reduce the treatment burden for patients, the treating physician, and the healthcare system.
  • Patient, clinician, and advocate voices are integrated in the Companys drug development process, enabling Rezolute to boldly address a range of severe conditions.
  • Rezolute is steadfast in its mission to create profound, positive, and lasting impact on patients lives.
  • Rezolute is also developing RZ402, an orally available plasma kallikrein inhibitor, for the treatment of diabetic macular edema.

Rezolute Reports Third Quarter Fiscal 2022 Financial Results and Highlights Company Progress

Retrieved on: 
Thursday, May 12, 2022
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REDWOOD CITY, Calif., May 12, 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 its financial results for the third quarter of fiscal 2022 ended March 31, 2022.

Key Points: 
  • The first half of 2022 has been dynamic and transformative for us, as we have announced positive clinical results for both RZ358 as well as RZ402, said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute.
  • Results showed that RZ402 was generally safe and well-tolerated without dose-limiting toxicities, including at higher doses than previously tested in the SAD study.
  • Results demonstrated dose-dependent increases in systemic exposures, with repeat-dosing to steady-state resulting in the highest concentrations of RZ402 explored to date.
  • The increase was primarily attributable to an increase in share-based compensation expense due to options granted to employees in the quarter.

Rezolute Announces Positive Data from its Phase 2b (RIZE) Study of RZ358 in Patients with Congenital Hyperinsulinism

Retrieved on: 
Sunday, May 1, 2022
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Julie Raskin, Founding Member and Executive Director of Congenital Hyperinsulinism International, added, I am happy to learn of the encouraging topline data from the RZ358 Phase 2b study.

Key Points: 
  • Julie Raskin, Founding Member and Executive Director of Congenital Hyperinsulinism International, added, I am happy to learn of the encouraging topline data from the RZ358 Phase 2b study.
  • A total of 23 patients participated in the study in four sequential dosing cohorts ranging from 3 mg/kg to 9 mg/kg.
  • Rezolute believes that RZ358 is ideally suited as a potential therapy for congenital hyperinsulinism (HI) and other conditions characterized by excessive insulin levels.
  • The Companys lead clinical asset, RZ358, is in late-stage development for the treatment of congenital hyperinsulinism, a rare pediatric endocrine disorder.