Registrational study in patients with tumor hyperinsulinism (HI) expected to commence mid-year Designation underscores need for therapies to treat severe hypoglycemia in the oncology setting REDWOOD CITY, Calif., May 05, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by HI, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to its investigational therapy, ersodetug, for the treatment of hypoglycemia caused by tumor HI.

Mon, May. 05, 2025

REDWOOD CITY, Calif., May 01, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism, today announced that management will participate in the following investor conferences:

Thu, May. 01, 2025

Topline results from phase 3 sunRIZE study, using ersodetug for the treatment of patients with congenital hyperinsulinism, expected in December 2025. Proof-of-concept was established in a phase 2 study using the oral small molecule plasma kallikrein inhibitor RZ402 for the treatment of patients with diabetic macular edema. The global diabetic macular edema market size is projected to reach $7.5 billion by 2034.

Thu, May. 01, 2025

NEW YORK, April 25, 2025 (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 closing of its previously announced underwritten offering (the “Offering”) of an aggregate of 24,940,769 shares of its common stock at an offering price of $3.25 per share, which includes 4,153,846 shares of common stock pursuant to the exercise in full of the underwriters' option to purchase additional shares of common stock and, to certain investors in lieu of common stock, pre-funded warrants to purchase up to 6,905,385 shares of common stock at an offering price of $3.2490 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.001 per share exercise price for each pre-funded warrant.

Fri, Apr. 25, 2025

Rezolute, Inc. RZLT on Wednesday announced the Independent Data Monitoring Committee's (DMC) recommendation to continue the Phase 3 sunRIZE study as planned in patients with congenital hyperinsulinism (HI) without increasing the study sample size.

Wed, Apr. 23, 2025