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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.
RZ402 is an oral therapy under development by Rezolute aimed at providing a less invasive treatment for Diabetic Macular Edema (DME), an eye condition linked to diabetes. During a recent KOL event, Dr. Robert Bhisitkul highlighted RZ402's potential to change DME treatment by reducing the burdens associated with current intravitreal injections. Rezolute launched a Phase 2 study in December 2022 to assess RZ402’s safety and efficacy, with top-line results expected in Q1 2024. This could address the increasing prevalence of DME, which affects over a million individuals in the U.S.
Rezolute, Inc. (Nasdaq: RZLT) is set to host a virtual conference call on March 22, 2023, at 4:30 p.m. EDT, to discuss its RZ402 Phase 2 clinical program for diabetic macular edema (DME). The event will feature expert insights from Dr. Robert Bhisitkul of UCSF. RZ402, a novel oral plasma kallikrein inhibitor, aims to improve DME treatment, traditionally reliant on invasive anti-VEGF injections. Preclinical results show RZ402 can reduce retinal vascular leakage by up to 90%, and early studies indicate strong bioavailability and safety. The company also plans to highlight its RZ358 program entering Phase 3 later this year.
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.