Welcome to our dedicated page for Rezolute news (Ticker: RZLT), a resource for investors and traders seeking the latest updates and insights on Rezolute stock.
Rezolute, Inc. (Nasdaq: RZLT) is a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI), including congenital and tumor forms of the condition. The RZLT news feed highlights company announcements, clinical trial updates, regulatory interactions and corporate developments related to its lead antibody therapy, ersodetug.
Investors and followers of Rezolute can use this page to review detailed updates on key Phase 3 programs such as the sunRIZE study in congenital hyperinsulinism and the upLIFT study in tumor hyperinsulinism. Company news has included topline results from sunRIZE, insights into pharmacologic activity and placebo effects in glucose endpoints, and plans to discuss the full dataset with the U.S. Food and Drug Administration under Breakthrough Therapy Designation.
News items also cover the evolution of the upLIFT trial design after alignment with the FDA on a streamlined, single-arm, open-label approach, as well as data from an Expanded Access Program in tumor HI that informed this strategy. In addition, Rezolute regularly reports on financial results, equity inducement grants under Nasdaq Listing Rule 5635(c)(4), participation in healthcare and investor conferences, and leadership appointments that support its development and potential commercialization plans for ersodetug.
By following RZLT news, readers can track how Rezolute communicates progress in its clinical programs, interprets study findings, and engages with regulators and the investment community. This page provides a centralized view of the company’s press releases and related disclosures, offering context for the ongoing development of ersodetug in rare hyperinsulinism indications.
Rezolute, a clinical-stage biopharmaceutical company, reported its third quarter financial results for fiscal 2024, ending March 31, 2024. The company announced the initiation of patient enrollment in the global Phase 3 clinical study of RZ358 for congenital hyperinsulinism (cHI), with topline results expected mid-2025. Rezolute also completed an in-vivo toxicology study in Norway rats, showing no liver abnormalities at the highest dose tested. Ongoing interactions with the FDA aim to resolve partial clinical holds for RZ358.
In other developments, Rezolute completed patient dosing in a Phase 2 study of RZ402 for diabetic macular edema, with topline results expected in May 2024. Financially, the company reported cash and equivalents of $81.6 million, a decrease from $118.4 million as of June 30, 2023. Research and development expenses were $12.4 million, and general and administrative expenses rose to $3.8 million. Net loss stood at $17.1 million, compared to $15.7 million a year ago.
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