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On Wednesday, BTIG analyst Julian Harrison reaffirmed a Buy rating on Rezolute (NASDAQ:RZLT), with a consistent price target of $15.00. The company, currently valued at $242 million, maintains strong analyst support with a consensus recommendation of 1.3 (Strong Buy). According to InvestingPro data, analyst targets range from $9 to $15, suggesting significant upside potential. Harrison highlighted the completion of enrollment for the sunRIZE clinical trial, which exceeded its original target by enrolling 62 participants, with an estimated 15% from U.S. locations. This progress keeps the data disclosure on track for December 2025. The company’s strong financial position, with a current ratio of 8.43 and more cash than debt on its balance sheet, provides solid backing for its clinical development programs. Discover more insights about Rezolute’s financial health with InvestingPro’s comprehensive research report.
Rezolute’s ersodetug has been granted Breakthrough Therapy Designation (BTD) by the FDA for congenital hyperinsulinism (cHI) and tumor-induced hypoglycemia (tumor HI), signaling a positive acknowledgment of the drug’s potential. The company anticipates filing a Biologics License Application (BLA) for ersodetug in cHI around mid-2026, following the expected release of top-line sunRIZE data.
The analyst expressed confidence in the likelihood of a successful outcome for the sunRIZE trial, citing previous significant results in the Phase 2b RIZE study. He believes ersodetug is poised to become a preferred treatment option for cHI, assuming the sunRIZE trial confirms differentiated safety and efficacy.
Despite the positive outlook, BTIG has adjusted the expected launch timelines for ersodetug, now anticipating market introduction for cHI and tumor HI treatments in mid-2027 and 2028, respectively, which is a slight delay from previous estimates. The $15 price target remains unchanged, as the firm has updated its net present value (NPV) sum-of-the-parts (SOTP) analysis to reflect these adjustments. Based on InvestingPro’s Fair Value analysis, the stock appears slightly overvalued at current levels, though this assessment doesn’t factor in potential future revenue from these pipeline products.
In other recent news, Rezolute, Inc. has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for its drug candidate, ersodetug, aimed at treating hypoglycemia caused by tumor hyperinsulinism. This designation is based on clinical data indicating a potential improvement over existing treatments. In a strategic financial move, Rezolute announced a public offering expected to raise approximately $90 million, with the proceeds directed towards research and development, general corporate expenses, and working capital. Guggenheim Securities is managing this offering, with notable investment firms participating.
Additionally, the company’s Phase 3 sunRIZE trial, evaluating ersodetug for congenital hyperinsulinism, will continue without changes following a recommendation from the Independent (LON:IOG) Data Monitoring Committee. The trial is on track, with patient enrollment expected to be completed soon and results anticipated in December 2025. Rezolute also announced the expansion of its Board of Directors with the appointment of Erik Harris, a biopharma veteran with expertise in commercializing rare disease treatments. This move aims to bolster the company’s strategic direction as it advances its lead programs. These developments reflect Rezolute’s ongoing efforts to address hypoglycemia through innovative therapies.
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