Rezolute’s Ersodetug Gains Momentum with FDA Streamlined Phase 3 Design and Promising Efficacy in Tumor-Induced Hyperinsulinism

In a report released today, Yun Zhong from Wedbush maintained a Buy rating on Rezolute, with a price target of $12.00.

Yun Zhong has given his Buy rating due to a combination of factors surrounding Rezolute’s recent developments. The FDA’s agreement to streamline the Phase 3 study design for ersodetug in treating hypoglycemia caused by tumor-induced hyperinsulinism (tHI) is a significant milestone. This new open-label design simplifies the study and focuses on patient recruitment, potentially accelerating the path to market.
Additionally, ersodetug has demonstrated promising efficacy in both islet cell tumors (ICTs) and non-islet cell tumors (NICTs), addressing a critical need for patients who are not candidates for surgical intervention. The positive outcomes from the expanded access program further support its potential, especially in cases where standard treatments have failed. The FDA’s acceptance of data from the sunRIZE study as confirmatory evidence underscores the drug’s broad applicability, enhancing confidence in its future success.

Based on the recent corporate insider activity of 29 insiders, corporate insider sentiment is positive on the stock. This means that over the past quarter there has been an increase of insiders buying their shares of RZLT in relation to earlier this year.