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 clinical-stage biopharmaceutical company focused on developing innovative drug therapies aimed at improving the lives of patients suffering from metabolic and orphan diseases. The company's core mission is to address significant unmet medical needs through a diversified pipeline of cutting-edge treatments.
One of Rezolute's most promising candidates is RZ358, currently in Phase 2 clinical trials. RZ358 is a monoclonal antibody designed for the treatment of congenital hyperinsulinism (CHI), an ultra-orphan condition. This drug has shown significant promise in improving hypoglycemia across multiple endpoints, with plans to report topline data by mid-second quarter 2024.
Another key asset is AB101, a once-weekly injectable basal insulin presently in Phase 1 trials. AB101 has the potential to revolutionize diabetes management by reducing the therapeutic burden on patients and enhancing compliance. Additionally, Rezolute is developing RZ402, a plasma kallikrein inhibitor targeting diabetic macular edema (DME), with plans to file an IND in the latter half of 2018.
Rezolute applies proprietary formulation and manufacturing capabilities to well-characterized molecules, creating differentiated, patent-protected therapies. This approach not only improves existing standards of care but also offers significant commercial potential. The company has received multiple designations for its products, including Orphan Drug Designation for RZ358 in the U.S. and Europe, and PRIME designation by the European Medicines Agency.
Recent developments include plans to complete enrollment for ongoing studies by the end of 2024 and to report topline results by mid-year 2025. These milestones underline Rezolute's commitment to advancing its clinical programs and bringing transformative therapies to market.
For more detailed information and latest updates, visit the company's official website at www.rezolutebio.com.
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.
Rezolute, Inc. (Nasdaq: RZLT) has successfully closed its underwritten registered direct offering, raising approximately $121.9 million. The offering included 18,026,315 shares at $3.80 each and pre-funded warrants for 12,921,055 shares at $3.799 each. Proceeds will support the development of RZ358 for Congenital Hyperinsulinism and RZ402 for Diabetic Macular Edema, along with general corporate needs. Key investors include Acuta Capital Partners and Janus Henderson Investors. Notably, some warrants require stockholder approval for share increase, to be sought by June 30, 2022.
Rezolute, Inc. (Nasdaq: RZLT) has announced an underwritten registered direct offering of 18,026,315 shares at $3.80 each, alongside pre-funded warrants for 12,921,055 shares at $3.799 each. The gross proceeds are anticipated to be around $130 million. The company intends to use the funds for the development of its therapies RZ358 for Congenital Hyperinsulinism and RZ402 for Diabetic Macular Edema, and for other corporate purposes. The offering is expected to close on or about May 4, 2022.
Rezolute, Inc. announced promising results from its Phase 2b RIZE study for RZ358, targeting congenital hyperinsulinism (HI). The study revealed a significant ~75% reduction in hypoglycemia events and over 50% improvement across all patients in the high-dose cohort, with no adverse drug reactions reported. The drug showed predictable, dose-dependent results and good safety profiles, paving the way for its potential use as a monotherapy. These findings support advancing RZ358 into a Phase 3 registrational program, aiming to address the urgent need for effective treatments in HI.
Rezolute, Inc. (RZLT) announced a late-breaking oral presentation of its Phase 2b RIZE Study data for RZ358 at the Pediatric Endocrine Society Annual Meeting on May 1, 2022. The study focused on congenital hyperinsulinism (HI), evaluating RZ358's safety, tolerability, and glycemic efficacy in patients inadequately controlled by existing therapies. Dr. Paul Thornton will present findings, with the conference call set for 2:30 p.m. ET on the same day. Rezolute aims to disrupt treatment paradigms for metabolic diseases with innovative therapies.
Rezolute, Inc. (Nasdaq: RZLT) has joined the Rare Disease Company Coalition, an alliance of life science firms focused on developing treatments for rare diseases. This collaboration aims to address challenges in rare disease drug development and advocate for supportive government policies. CEO Nevan Charles Elam highlighted the importance of the coalition in fostering understanding among stakeholders. Rezolute is committed to innovating treatments for severe metabolic diseases, with its lead asset, RZ358, in late-stage development for congenital hyperinsulinism.
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