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Rezolute Announces Presentation of Participant Baseline Data from its Fully Enrolled Phase 3 Study of Ersodetug in Congenital Hyperinsulinism at the Upcoming Annual Meeting of the Endocrine Society (ENDO 2025)
Globenewswire· 2025-07-09 19:30
REDWOOD CITY, Calif., July 09, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI), today announced that the abstract titled “Preliminary Patient Demographics And Baseline Characteristics From A Phase 3 Study (sunRIZE) Of Ersodetug For Hypoglycemia Due To Congenital Hyperinsulinism: Trial In Progress” has been selected for a late-breaking presentation at ENDO 2025 taking place ...
Rezolute Announces Completion of Enrollment in the Phase 3 sunRIZE Study of Ersodetug in Patients with Congenital Hyperinsulinism
Globenewswire· 2025-05-28 20:00
Target enrollment exceeded with 62 participants enrolled, including approximately 15 percent from U.S. sites Topline data is anticipated in December of 2025 REDWOOD CITY, Calif., May 28, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI), today announced that enrollment is complete in the sunRIZE study, a global, Phase 3 multicenter, double-blind, randomized, placebo-controlle ...
Rezolute Reports Third Quarter Fiscal 2025 Financial Results and Provides Business Update
Globenewswire· 2025-05-14 04:05
sunRIZE enrollment on track including U.S. sites and expected to be completed in May 2025; topline data anticipated in December 2025 U.S. Food and Drug Administration (FDA) grants Breakthrough Therapy Designation to ersodetug for hypoglycemia due to tumor hyperinsulinism REDWOOD CITY, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI), today reported financial ...
XOMA Royalty Reports First Quarter 2025 Financial Results and Highlights Business Achievements
Globenewswire· 2025-05-13 19:30
文章核心观点 XOMA Royalty Corporation公布2025年第一季度财务结果,展示关键管线资产进展、稳定现金收入和增加的股票回购活动,有望实现持续现金流 [1][2]。 各部分总结 管线进展 - Day One Biopharmaceuticals和Ipsen的tovorafenib的上市许可申请获欧洲药品管理局受理 [1] - 武田启动mezagitamab治疗慢性原发性免疫性血小板减少症的3期试验 [1] 业务发展 - 参与联合特许权融资交易,获得Castle Creek Biosciences的D - Fi经济权益 [1] - 成功出售所有未合作的Kinnate资产 [1] 现金收入 - 2025年第一季度收到1800万美元,其中特许权收入1340万美元 [1][15] 特许权和里程碑收购 - 向Castle Creek Biosciences的7500万美元联合特许权融资交易出资500万美元,获得D - Fi特许权权益 [3] - Rezolute的ersodetug获FDA突破性疗法认定,sunRIZE 3期试验进展顺利,预计2025年5月完成入组,12月公布顶线数据 [3] - 向Affitech支付600万美元里程碑款项,为VABYSMO达到特定销售阈值的最后一笔付款 [3] - Daré Bioscience计划让Sildenafil Cream 3.6%按处方销售,预计2025年第四季度通过外包合作伙伴提供 [3][5][6] 合作伙伴更新 - Day One Biopharmaceuticals的合作伙伴Ipsen向欧洲药品管理局提交tovorafenib上市许可申请,公司获400万美元里程碑付款 [5] - 武田3期临床试验首位患者给药,公司获300万美元净里程碑付款 [5] - 2025年初出售五项未合作的Kinnate资产,部分预付款将分配给Kinnate CVR持有人 [5] 2025年预期事件 - 欧洲药品管理局对Day One的tovorafenib上市许可申请作出决定 [6] - Rezolute完成sunRIZE 3期临床试验入组,公布顶线数据,启动ersodetug治疗肿瘤性高胰岛素血症低血糖的3期注册研究 [6] - Gossamer / Chiesi公布PROSERA 3期研究顶线结果,启动肺动脉高压相关注册3期研究 [6] - Daré Bioscience使Sildenafil Cream按处方销售,启动一项3期注册临床试验 [6] 2025年第一季度财务结果 - 现金收入1800万美元,其中合作伙伴商业销售1340万美元,里程碑和费用460万美元 [7][15] - 总收入1590万美元,2024年同期为150万美元,主要因VABYSMO收入、Day One和Ipsen申请相关里程碑、武田合作付款及OJEMDA™特许权收入增加 [7][8] - 研发费用130万美元,2024年同期为3.3万美元,因武田合作许可费和KIN - 3248临床试验成本增加 [9] - 一般及行政费用810万美元,2024年同期为850万美元,因股票补偿成本减少和咨询成本增加 [10] - 利息费用2025年和2024年第一季度分别为350万和360万美元 [12] - 其他净费用10万美元,2024年同期为其他净收入200万美元,因投资公允价值和收入减少 [13] - 净收入240万美元,2024年同期净亏损860万美元 [14] - 3月31日现金及现金等价物9500万美元,2024年12月31日为1.064亿美元,第一季度收购资产、回购股票和支付股息 [15]
Rezolute to Participate in Upcoming Investor Conferences
Globenewswire· 2025-05-01 20:00
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: Event: The Citizens JMP Life Sciences Conference Date: May 7-8, 2025 Event: H.C. Wainwright BioConnect Investor Conference Date: May 20, 2025 Event: Craig-Hallum Institu ...