REZOLUTE INC. overview

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) --...

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...

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. Management will be participating in one-on-one investor meetings throughout the conference....

Breakthrough Therapy Designation granted based on key positive data from the Phase 2b (RIZE) study and current unmet medical need in congenital hyperinsulinism (HI) Ersodetug continues to advance in clinical development as a potential treatment for hypoglycemia caused by all forms of hyperinsulinism; topline sunRIZE data expected second half of this year REDWOOD CITY, Calif., Jan. 07, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage...

REDWOOD CITY, Calif., Dec. 05, 2024 (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 its compensation committee has approved the issuance of One Hundred and Fifty Thousand (150,000) shares of its common stock as an inducement award (the “Inducement Award”) permitted under Nasdaq Rule 5635(c)(4) to its...

REDWOOD CITY, Calif., Dec. 03, 2024 (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 the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ersodetug for the treatment of hypoglycemia due to tumor HI. "FDA's granting of Orphan Drug Designation is a recognition of the serious...

Ersodetug, a novel, fully human monoclonal antibody for the treatment of hyperinsulinism (HI), advancing in two late-stage, registrational clinical trials in two indications Phase 3 sunRIZE study on track; U.S. enrollment expected to commence in the first part of 2025 Phase 3 tumor HI study expected to commence in the first half of 2025 REDWOOD CITY, Calif., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”) , a late-stage biopharmaceutical...

REDWOOD CITY, Calif., Nov. 05, 2024 (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 following investor conferences: Event : Guggenheim’s Innaugural Healthcare Innovation Conference Date : November 11-13, 2024 Event : Jefferies London Healthcare Conference Date :...