Welcome to our dedicated page for Rezolute news (Ticker: RZLT), a resource for investors and traders seeking the latest updates and insights on Rezolute stock.
Rezolute, Inc. (Nasdaq: RZLT) is a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI), including congenital and tumor forms of the condition. The RZLT news feed highlights company announcements, clinical trial updates, regulatory interactions and corporate developments related to its lead antibody therapy, ersodetug.
Investors and followers of Rezolute can use this page to review detailed updates on key Phase 3 programs such as the sunRIZE study in congenital hyperinsulinism and the upLIFT study in tumor hyperinsulinism. Company news has included topline results from sunRIZE, insights into pharmacologic activity and placebo effects in glucose endpoints, and plans to discuss the full dataset with the U.S. Food and Drug Administration under Breakthrough Therapy Designation.
News items also cover the evolution of the upLIFT trial design after alignment with the FDA on a streamlined, single-arm, open-label approach, as well as data from an Expanded Access Program in tumor HI that informed this strategy. In addition, Rezolute regularly reports on financial results, equity inducement grants under Nasdaq Listing Rule 5635(c)(4), participation in healthcare and investor conferences, and leadership appointments that support its development and potential commercialization plans for ersodetug.
By following RZLT news, readers can track how Rezolute communicates progress in its clinical programs, interprets study findings, and engages with regulators and the investment community. This page provides a centralized view of the company’s press releases and related disclosures, offering context for the ongoing development of ersodetug in rare hyperinsulinism indications.
Rezolute, Inc. (Nasdaq: RZLT) announced its second-quarter financial results for fiscal 2023, highlighting its ongoing clinical advancements. The company initiated a Phase 2 proof-of-concept study for RZ402 aimed at treating diabetic macular edema and is preparing for a global Phase 3 study for RZ358 for congenital hyperinsulinism. As of December 31, 2022, cash and cash equivalents stood at $146.7 million. Research and development expenses increased to $10.9 million from $9.5 million year-over-year, attributed to higher personnel costs. General and administrative expenses also rose to $3.4 million from $2.7 million. The net loss for the quarter was $13.6 million, compared to $12.6 million in the prior year.
Rezolute, Inc. (RZLT) announced the initiation of a Phase 2 proof-of-concept study for RZ402, an oral plasma kallikrein inhibitor aimed at treating Diabetic Macular Edema (DME). This milestone addresses the unmet needs of DME patients, who currently rely on cumbersome anti-VEGF eye injections. The study will evaluate RZ402's safety and efficacy over a 12-week period across approximately 100 participants. RZ402 shows promise based on prior positive Phase 1b trial results and aims to improve treatment compliance and clinical outcomes for DME.
Rezolute, Inc. (RZLT) announced positive results from its clinical programs and a $130 million financing to advance RZ358 and RZ402. The company plans to initiate a Phase 2 proof-of-concept study for RZ402, an oral plasma kallikrein inhibitor for diabetic macular edema, by year-end. RZ358, a treatment for congenital hyperinsulinism, demonstrated significant hypoglycemia event reduction. Financially, cash and cash equivalents stood at $154.3 million, with a net loss of $9.8 million for Q1 fiscal 2023, signaling increased R&D expenses.
Rezolute, Inc. (Nasdaq: RZLT), a biopharmaceutical company focused on treating metabolic diseases, announced that CEO Nevan Charles Elam will participate in a fireside chat at the Jefferies London Healthcare Conference on November 17, 2022, at 11:25 a.m. EST. The chat will be streamed live on the Rezolute website and available for replay for 90 days. Rezolute is developing innovative therapies for rare and chronic metabolic diseases, notably RZ358 for congenital hyperinsulinism and RZ402 for diabetic macular edema, aiming to enhance patient outcomes and reduce treatment burdens.
Rezolute, Inc. (Nasdaq: RZLT) announced it will present clinical data from its Phase 1b multiple-ascending dose study of RZ402 at The Retina Society 55th Annual Scientific Meeting, scheduled for November 2-5, 2022, in Pasadena, CA. The presentation, titled RZ402: a Novel Orally Administered Plasma Kallikrein Inhibitor to Target Diabetic Macular Edema, will be delivered by Dr. Quan Dong Nguyen on November 3, 2022, from 1:47 p.m. to 2:52 p.m. ET. Rezolute is focused on developing transformative therapies for chronic metabolic diseases.
Rezolute, Inc. (RZLT) announced a $130 million registered direct offering and private placement to fund clinical trials for RZ358 and RZ402. The fourth quarter fiscal 2022 results showed a net loss of $9.4 million, increasing from $6.5 million year-over-year. R&D expenses rose to $8.6 million, driven by clinical trial costs, while G&A expenses increased to $2.7 million. Positive developments include favorable safety data from the Phase 2b RIZE study, which showed a 75% reduction in hypoglycemia events for RZ358. The company holds $150.4 million in cash as of June 30, 2022.
Rezolute, Inc. (Nasdaq: RZLT) has announced an oral presentation at the upcoming 60th European Society for Paediatric Endocrinology (ESPE) meeting, held from September 15-17, 2022, in Rome. The presentation will focus on additional data from the Phase 2b RIZE Study of RZ358 for congenital hyperinsulinism. Dr. Hüseyin Demirbilek will present findings regarding the unmet treatment needs and glycemic responses associated with RZ358. This clinical asset is in late-stage development aimed at improving outcomes for patients with this rare metabolic disease.
Rezolute, Inc. (RZLT) has announced the promotion of Brian Roberts, M.D. to Chief Medical Officer, effective June 1, 2022. Dr. Roberts has been with Rezolute since 2017, previously serving as Senior Vice President of Clinical Development. His extensive experience includes leading clinical strategies for metabolic disease therapies. CEO Nevan Elam emphasized Dr. Roberts' integral role in advancing the company's clinical development plans, particularly for the lead asset RZ358, aimed at treating congenital hyperinsulinism. This transition aims to enhance leadership as Rezolute progresses its late-stage clinical programs.
Rezolute announced a $130 million registered direct offering and concurrent private placement, aiming to fund key developmental phases for its drug RZ358 and initiate a Phase 2 study for RZ402. Positive topline results from the Phase 2b RIZE study for RZ358 showed a significant 75% reduction in hypoglycemia events, demonstrating its potential as a monotherapy for congenital hyperinsulinism. Financially, cash reserves stand at $63.4 million, with a net loss of $11.2 million for Q3 fiscal 2022.
Rezolute, Inc. (Nasdaq: RZLT) announced a corporate update conference call on May 4, 2022, at 4:30 p.m. ET to discuss recent advancements in its drug pipeline. The call will focus on RZ358 for congenital hyperinsulinism and RZ402 for diabetic macular edema. Interested analysts and investors can join by calling 1-877-270-2148 (U.S.) or 1-412-902-6510 (internationally), with a live webcast available on the company's investor page. A replay will be accessible for 90 days post-event.
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