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REDWOOD CITY, Calif. - Rezolute, Inc. (NASDAQ:RZLT), a biopharmaceutical company focusing on rare diseases with a market capitalization of $188 million, announced today that the Independent Data Monitoring Committee (DMC) has recommended the continuation of its Phase 3 sunRIZE study without increasing the sample size. According to InvestingPro data, the company’s stock has shown significant momentum with a 17.8% return over the past week, despite experiencing broader volatility in recent months. The trial, evaluating the efficacy of ersodetug in treating congenital hyperinsulinism (HI), is on track with patient enrollment expected to be completed next month and topline results anticipated in December 2025.
The recommendation by the DMC to maintain the current trial protocol comes after an interim analysis based on primary study endpoints. Although Rezolute remains blinded to the partial data and has not been informed of the statistical outputs, the DMC’s advice supports the company’s initial design and assumptions for the study. InvestingPro analysis reveals the company maintains a strong financial position with a current ratio of 9.3, indicating robust liquidity to support its clinical programs. Get access to detailed financial health metrics and 7 additional exclusive ProTips with an InvestingPro subscription.
The sunRIZE study is a randomized, double-blind, placebo-controlled trial involving participants aged between 3 months and 45 years, from over a dozen countries. It is designed to assess the safety and effectiveness of ersodetug, a fully human monoclonal antibody that targets the insulin receptor to reduce hypoglycemia in patients with congenital HI.
This condition, considered the most prevalent cause of recurrent and persistent hypoglycemia in children, can lead to severe brain injury or death if not appropriately managed. Current treatments for congenital HI often require long-term medication or surgery, with over half of the affected children needing ongoing medical care.
The DMC’s interim analysis was intended to determine the necessity of modifying the study’s sample size to ensure sufficient power and statistical confidence in the final analysis outcomes. The positive outcome of this analysis suggests that the existing study design is adequate to evaluate the efficacy of ersodetug.
Rezolute’s Chief Medical Officer, Brian Roberts, M.D., expressed optimism about the DMC’s endorsement and the potential of ersodetug to become a leading treatment option for hyperinsulinism. Analysts share this optimism, with price targets ranging from $9 to $16 per share, according to InvestingPro data. Discover comprehensive analysis and Fair Value estimates for over 1,400 stocks with an InvestingPro subscription.
The information in this article is based on a press release statement from Rezolute, Inc.
In other recent news, Rezolute, Inc. has made significant strides in its clinical and financial endeavors. The company reported its second quarter fiscal year 2025 financial results, ending the period with approximately $105 million in cash reserves, which analysts at JMP Securities believe will support ongoing development efforts without immediate funding concerns. Rezolute is advancing its Phase 3 programs for its drug candidate, ersodetug, with notable progress in the sunRIZE trial for congenital hyperinsulinism. The independent Data Monitoring Committee approved the enrollment of infants in the double-blind portion of the study, confirming the safety of the drug at tested doses.
JMP Securities raised its price target for Rezolute to $9, maintaining a Market Outperform rating, while H.C. Wainwright reiterated a Buy rating with a $14 target, citing the recent safety approvals as a positive indicator. The U.S. Food and Drug Administration previously lifted partial clinical holds on ersodetug, allowing for further patient enrollment in the United States. Rezolute anticipates completing enrollment for the sunRIZE study by the second quarter of 2025, with topline results expected in the fourth quarter of the same year. The company also announced the appointment of Erik Harris to its Board of Directors, a strategic move as it prepares for the commercialization of its lead programs.
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