Core Viewpoint - Rezolute, Inc. has announced the removal of partial clinical holds by the FDA on RZ358 (ersodetug), a therapy for hypoglycemia caused by congenital hyperinsulinism, allowing the company to proceed with its clinical studies in the U.S. [1][3] Group 1: Clinical Development - Ersodetug is currently being studied in the sunRIZE Phase 3 trial, which is a global, multi-center, double-blind, randomized, placebo-controlled study aimed at evaluating its safety and efficacy in patients with congenital hyperinsulinism [2][5] - The company plans to initiate study start-up activities in the U.S. and expects U.S. enrollment to begin in early 2025, with topline data anticipated in the second half of 2025 [2][3] Group 2: Drug Mechanism and Target Population - Ersodetug is a fully human monoclonal antibody that targets insulin receptors to mitigate the effects of insulin receptor over-activation, thereby improving hypoglycemia in hyperinsulinism conditions [4] - The sunRIZE study will enroll participants aged between 3 months and 45 years, with a target of up to 56 participants across more than a dozen countries [5]

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 ...

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 ...

In addition, the Company has entered into an agreement for a concurrent private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), of 1,500,000 shares of its common stock, at a sale price of $4.00 per share. Contacts: Rezolute, Inc. NEW YORK, June 27, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious ...

Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). The Company's antibody therapy, RZ358, is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI). | --- | |---------------------------------------| | | | Contacts: | | Rezolute, Inc. | | Christen Baglaneas | | cbaglanea ...

NEW YORK, June 13, 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 the pricing of its previously announced underwritten public offering of an aggregate of 11,250,000 shares of its common stock at an offering price of $4.00 per share, and, to certain investors in lieu of common stock, pre-funded warrants to purchase up to 3,750,000 sha ...

Jefferies and Cantor are acting as the joint book-running managers for the offering. BTIG, Craig-Hallum, H.C. Wainwright & Co., Jones and Maxim Group LLC are acting as co-managers for the offering. A shelf registration statement on Form S-3 (File No. 333-275562) relating to the securities to be offered in the public offering was filed with the Securities and Exchange Commission (the "SEC") and was declared effective on November 29, 2023. The public offering will be made only by means of a prospectus supplem ...

NEW YORK, June 13, 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 is commencing an underwritten public offering of shares of its common stock (or pre-funded warrants to purchase its common stock in lieu thereof). In addition, the Company intends to grant the underwriters an option for a period of 30 days to purchase up to an ...

NEW YORK, June 13, 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 is commencing an underwritten public offering of shares of its common stock (or pre-funded warrants to purchase its common stock in lieu thereof). In addition, the Company intends to grant the underwriters an option for a period of 30 days to purchase up to an ...

Core Insights - Rezolute, Inc. announced positive topline results from the Phase 2 clinical study of RZ402, demonstrating a good safety profile and significant reduction in central subfield thickness (CST) in patients with diabetic macular edema (DME) [1][5][9] Study Results - The study enrolled 94 participants in a multi-center, randomized, double-masked, placebo-controlled design, evaluating RZ402 as a monotherapy over a 12-week treatment period [2][6] - RZ402 met both primary endpoints, showing a significant improvement in CST across all dosage levels compared to placebo, with a maximum reduction of approximately 50 microns (p=0.02) [5][6] - The 200 mg dose of RZ402 yielded the largest response, with a notable improvement of approximately 75 microns in patients with CST ≥400 microns [6][11] Safety Profile - RZ402 was reported to be safe and well-tolerated, with adverse events generally mild and comparable to placebo [11] - No ocular adverse effects typically associated with intravitreal injections were observed, and serious adverse events were deemed unrelated to the study drug [11] Treatment Implications - The results suggest the potential for RZ402 to serve as a first-line, non-invasive treatment for DME, allowing for earlier intervention and addressing both eyes simultaneously [2][3] - Current standard care involves invasive anti-VEGF injections, which can lead to treatment delays and compliance issues; RZ402's oral administration may alleviate these challenges [8][9] Future Plans - The company plans to present further findings at an upcoming medical conference and will host a virtual investor event to discuss the topline results [7][8]