FDA lifts partial clinical holds on ersodetug for the treatment of congenital HI; Phase 3 sunRIZE study to proceed in the U.S. Phase 3 study for ersodetug for the treatment of tumor HI expected to commence in the first half of 2025 REDWOOD CITY, Calif., Sept. 19, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, today reported financial resul ...

文章核心观点 - 美国食品药品监督管理局(FDA)已经解除了对Rezolute公司的RZ358(ersodetug)药物进行III期临床试验的部分临床禁令 [1] - RZ358是用于治疗先天性高胰岛素血症(HI)引起的低血糖的药物,这是一种罕见的儿童遗传性疾病 [1] - Rezolute公司正准备在美国启动RZ358的III期临床试验,预计2025年初开始患者入组,2025年下半年获得试验数据 [1] 公司情况 - 今年以来,Rezolute公司股价上涨435%,而同期行业下跌2.8% [2] - Rezolute公司目前没有上市产品,RZ358的成功开发及其他管线的进展是公司的关键重点 [5] - Rezolute公司目前被评为Zacks Rank 3(Hold),而Illumina、Krystal Biotech和Fulcrum Therapeutics等公司被评为Zacks Rank 1(Strong Buy) [6][7] RZ358临床试验进展 - Rezolute公司于2023年12月启动了RZ358的III期关键性临床试验sunRIZE,评估其在先天性HI患者中的安全性和有效性 [3] - 此前FDA曾因RZ358在Sprague Dawley大鼠中出现肝毒性而对该试验实施了部分临床禁令,但现已解除 [3] - FDA认为该肝毒性是Sprague Dawley大鼠特有的,与人类无关 [3] - II期RIZE试验显示RZ358可以显著改善先天性HI患者的低血糖水平 [3] - FDA还批准了RZ358用于治疗肿瘤性高胰岛素血症引起的低血糖的III期临床试验,预计2025年上半年开始患者入组 [5]

REDWOOD CITY, Calif., Sept. 09, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company developing a novel therapy to treat hyperinsulinism (HI), today announced that the U.S. Food and Drug Administration (FDA) has removed the partial clinical holds on RZ358 (ersodetug), a potential treatment for hypoglycemia caused by congenital HI. Ersodetug is currently being studied in sunRIZE, a global Phase 3, multi-center, double-blind, randomized, place ...

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 ...

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 rare diseases, today announced that the underwriters of its previously announced public offering, which closed on June 24, 2024, have exercised an over-allotment option to purchase an additional 1,786,589 shares of the Company’s common stock at the public offering price of $4.00 per share, less unde ...

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 th ...

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 ...

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 ...

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 a ...

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 a ...