Core Viewpoint - Rezolute, Inc. has received FDA approval to remove partial clinical holds on its phase III study for RZ358, a treatment for congenital hyperinsulinism, leading to a significant increase in its stock price by 22.1% on September 9 [1]. Company Developments - The phase III sunRIZE study will evaluate the safety and efficacy of RZ358 in patients aged three months to 45 years with congenital hyperinsulinism [2]. - Rezolute is preparing to initiate start-up activities for the study in the U.S., with participant enrollment expected to begin in early 2025 and top-line data anticipated in the second half of 2025 [3]. - The company has seen a remarkable 435% increase in its shares year-to-date, contrasting with a 2.8% decline in the industry [3]. - The pivotal phase III sunRIZE study was initiated in December 2023, following positive results from the phase IIb RIZE study, which demonstrated significant improvements in hypoglycemia levels [5]. Regulatory Background - The FDA had previously placed partial clinical holds due to liver toxicity observed in preclinical studies with Sprague Dawley rats, but has since determined that this toxicity is strain-specific and not relevant to humans [4]. Future Prospects - The FDA has also cleared Rezolute's investigational new drug application for RZ358 to treat hypoglycemia in patients with tumor-induced hyperinsulinism, with enrollment expected to begin in the first half of 2025 [6]. - The successful development of RZ358 and other pipeline candidates is crucial for the company's future, as it currently lacks a marketed product [6].
RZLT Stock Up as FDA Lifts Clinical Holds on Rare Disease Study