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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 11:30
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 12:00
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· 2025-05-13 20:05
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 11:30
Core Insights - XOMA Royalty Corporation reported a strong first quarter for 2025, with total income and revenues of $15.9 million, a significant increase from $1.5 million in the same period in 2024, driven by various milestone payments and royalties [7][21]. - The company received $18.0 million in cash receipts during the first quarter, including $13.4 million from royalties and commercial payments, and $4.6 million from milestones and fees [15][7]. - XOMA Royalty is focused on prudent cash deployment, strict expense control, and opportunistic share repurchases, indicating a commitment to generating shareholder value [2][6]. Pipeline Advancements - The Marketing Authorization Application (MAA) for tovorafenib by Day One Biopharmaceuticals and Ipsen was accepted for review by the European Marketing Authority (EMA) [1]. - Takeda initiated a Phase 3 trial for mezagitamab, targeting chronic primary immune thrombocytopenia [1]. Business Development - XOMA Royalty acquired a royalty interest in Castle Creek Biosciences' D-Fi (FCX-007), a Phase 3 asset for dystrophic epidermolysis bullosa, contributing $5 million to a $75 million syndicated royalty financing transaction [3][1]. - The company successfully sold all unpartnered Kinnate assets, with a portion of any upfront payments to be distributed to Kinnate CVR holders [1][3]. Financial Performance - The company recorded a net income of $2.4 million for the first quarter of 2025, compared to a net loss of $8.6 million in the first quarter of 2024 [14][22]. - Research and Development (R&D) expenses increased to $1.3 million in Q1 2025 from $33,000 in Q1 2024, primarily due to licensing fees and clinical trial costs [9][21]. - General and Administrative (G&A) expenses decreased to $8.1 million in Q1 2025 from $8.5 million in Q1 2024, mainly due to lower stock compensation costs [10][11]. Anticipated Events - Key upcoming events include the EMA's decision on the MAA for tovorafenib and the completion of enrollment in the sunRIZE Phase 3 clinical trial for ersodetug, with topline data expected in December 2025 [6][1].
Rezolute to Participate in Upcoming Investor Conferences
Globenewswire· 2025-05-01 12:00
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 ...