Rezolute, INC 8-K filings

Rezolute, Inc. announced positive interim data from its Phase 3 upLIFT study of ersodetug for tumor hyperinsulinism, with 6 of 8 participants meeting the primary endpoint.

Rezolute, Inc. announced its third quarter fiscal 2026 financial results, detailing positive clinical data for its hyperinsulinism drug ersodetug and providing updates on ongoing studies.

Rezolute announced expanded analyses from its Phase 3 sunRIZE study of ersodetug for congenital hyperinsulinism, showing consistent glycemic improvements and high OLE participation.

Rezolute, Inc. announced outcomes from its recent Type B meeting with the FDA regarding its ersodetug program for congenital hyperinsulinism, where the FDA encouraged submission of comprehensive study data.

Rezolute, Inc. reported Q2 fiscal 2026 financial results and announced that its Phase 3 sunRIZE study for congenital hyperinsulinism did not meet primary or key secondary endpoints.

Rezolute, Inc. announced that its Phase 3 sunRIZE study for congenital hyperinsulinism did not meet primary or key secondary endpoints, while its Expanded Access Program for tumor hyperinsulinism showed compelling evidence of ersodetug activity.

Rezolute, Inc. announced the results of its 2026 annual meeting of stockholders, where all director nominees were elected and key proposals, including an equity plan amendment, were approved.

Rezolute, Inc. provided a comprehensive update on its Ersodetug development program for congenital and tumor hyperinsulinism, highlighting significant clinical and regulatory progress and a combined U.S. market opportunity of 4,500 patients.

Rezolute, Inc. announced its first quarter fiscal 2026 financial results and provided updates on its late-stage clinical trials for ersodetug in hyperinsulinism, including expected topline data in December 2025 for congenital HI.

Rezolute, Inc. amended executive employment agreements to include tax gross-ups for change-of-control payments and terminated its at-the-market equity offering program with Jefferies LLC.

Rezolute, Inc. announced significant progress in its ersodetug clinical trials for hyperinsulinism, including FDA alignment for a streamlined Phase 3 study, alongside its fourth quarter and full fiscal year 2025 financial results.

Rezolute, Inc. announced FDA alignment on a significantly streamlined Phase 3 clinical development path for its ersodetug trial in tumor hyperinsulinism, expediting potential therapy availability.

Rezolute, Inc. appointed Sunil Karnawat as Chief Commercial Officer to lead commercialization efforts for ersodetug, its late-stage rare disease therapy.

Rezolute, Inc. announced the completion of enrollment for its pivotal Phase 3 sunRIZE clinical study of ersodetug for congenital hyperinsulinism, with topline results expected by the end of 2025.

Rezolute, Inc. filed an amended 8-K to announce the appointment of Erik Harris to its Compensation Committee, effective July 1, 2025.

Rezolute, Inc. announced the completion of a private placement, raising approximately $4.2 million through the sale of common stock to certain insiders and other investors, which is less than the previously agreed-upon maximum of $10 million.

Rezolute reports progress in its hyperinsulinism treatment programs, including FDA Breakthrough Therapy Designation for ersodetug, and announces its third quarter fiscal 2025 financial results.

Rezolute, Inc. successfully closes its underwritten offering, raising approximately $96.9 million, and announces a separate $4.2 million private placement.

Rezolute, Inc. has announced a $90 million registered direct offering of common stock and pre-funded warrants to advance its research and development efforts.

Rezolute, Inc. announced a positive recommendation from the Independent Data Monitoring Committee (DMC) to continue its Phase 3 sunRIZE study of Ersodetug in Congenital Hyperinsulinism (HI) as planned, without increasing the sample size.

Rezolute, Inc. has elected Erik Harris, a seasoned biopharmaceutical executive, to its Board of Directors, effective March 25, 2025.

Rezolute reports progress on its lead drug ersodetug, including Breakthrough Therapy Designation and Orphan Drug Designation, along with financial results for Q2 fiscal year 2025.

Rezolute reports positive outcomes from the Data Monitoring Committee review of the open-label arm of its Phase 3 sunRIZE study of ersodetug for congenital hyperinsulinism, allowing enrollment of infants into the double-blind portion of the study.

Rezolute, Inc. shares a video testimonial highlighting a patient's positive experience with ersodetug, an investigational drug, in a Phase 2 clinical study for congenital hyperinsulinism (HI).

Rezolute's ersodetug has been granted Breakthrough Therapy Designation by the FDA for treating hypoglycemia due to congenital hyperinsulinism, based on positive Phase 2b study results.

Rezolute Inc. successfully increased its authorized common stock to 165 million shares and held its annual meeting, where all director nominees were elected and other proposals were approved.

Rezolute, Inc. announced its first quarter fiscal 2025 financial results and provided an update on its clinical programs for the treatment of hyperinsulinism, including the progress of two Phase 3 trials.

Rezolute reports its fiscal year 2024 financial results, highlights progress in its clinical programs, and announces the lifting of partial clinical holds on its lead drug candidate, ersodetug.

The FDA has removed partial clinical holds on Rezolute's RZ358, allowing the company to proceed with U.S. enrollment in its Phase 3 study for congenital hyperinsulinism.

Rezolute, Inc. has announced FDA clearance for its Investigational New Drug application for RZ358 (ersodetug) to treat hypoglycemia in patients with tumor hyperinsulinism, marking a significant step towards a potential new treatment.