RezoluteNASDAQ: RZLT

FDA lifts partial clinical holds on ersodetug for the treatment of congenital HI; Phase 3 sunRIZE study to proceed in the U.S.

The FDA removes the partial clinical holds on Rezolute's phase III study evaluating RZ358 for treating congenital hyperinsulinism.

Rezolute Inc said on Monday the U.S. Food and Drug Administration has removed the partial clinical hold on its late-stage study testing its experimental treatment for low blood sugar.

Commencing study startup activities in the U.S.; participant enrollment anticipated in early 2025 Commencing study startup activities in the U.S.; participant enrollment anticipated in early 2025

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 Investigational New Drug (IND) application for RZ358 (ersodetug) to treat hypoglycemia in patients with tumor hyperinsulinism (HI).

Additional $6.7M in funding resulting in approximately $67M in gross proceeds Additional $6.7M in funding resulting in approximately $67M in gross proceeds

NEW YORK, June 24, 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 closing of its underwritten public offering of 11,250,000 shares of its common stock at a price to the public of $4.00 per share and, to certain investors in lieu of common stock, pre-funded warrants to purchase 3,750,000 shares of its common stock at a price to the public of $3.999 per pre-funded warrant, in each case, before underwriting discounts and commissions. All of the shares and warrants in the public offering were sold by the Company.

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 additional 15 percent of the number of shares of its common stock plus the shares of common stock underlying pre-funded warrants sold in connection with the public offering. The public offering is subject to market and other conditions, and there can be no assurance as to whether or when the public offering may be completed or as to the actual size or terms of the public offering. All of the shares in the public offering are being offered by the Company.