Rezolute ( (RZLT) ) just unveiled an announcement.
Rezolute, Inc. announced that outcomes from a Data Monitoring Committee (DMC) review of the open-label arm of its Phase 3 sunRIZE study showed that the targeted drug concentrations for ersodetug were safely reached in infants under one year old. This approval allows the enrollment of infants into the double-blind portion of the study, which aims to treat hypoglycemia due to congenital hyperinsulinism. The enrollment is expected to complete in the second quarter of 2025, with topline results anticipated by the end of the year. The interim analysis will guide the sample size adequacy and may adjust it to enhance statistical confidence.
More about Rezolute
Rezolute, Inc. is a late-stage biopharmaceutical company focused on developing transformative therapies for rare diseases with serious unmet needs. The company’s primary product is ersodetug, an antibody therapy designed to treat hypoglycemia caused by hyperinsulinism, including congenital hyperinsulinism.
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Average Trading Volume: 449,144
Technical Sentiment Consensus Rating: Sell
Current Market Cap: $303.6M
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