Rezolute (RZLT): Mixed Phase 3 Data, Regulatory Uncertainty in Congenital HI, and Tumor HI Optionality Support Reiterated Hold Rating

In a report released today, Yun Zhong from Wedbush maintained a Hold rating on Rezolute, with a price target of $2.00.

Yun Zhong has given his Hold rating due to a combination of factors related to Rezolute’s lead program, ersodetug, in hyperinsulinism. The recently reported Phase 3 sunRIZE data show that the drug can influence insulin receptor activity and appears to lessen both the number of hypoglycemia episodes and the time patients spend in low blood sugar, but the degree of benefit is not clearly strong enough to support regulatory approval at this stage. The study failed its primary endpoint because the reduction in hypoglycemia events on the higher ersodetug dose was only modestly better than placebo, suggesting a substantial placebo or study-participation effect, possibly driven by more intensive glucose monitoring and adjustments in standard-of-care management. In addition, the key secondary endpoint based on continuous glucose monitoring did not achieve statistical significance, and the magnitude of benefit was weaker than what had been observed previously in Phase 2, underlining uncertainty about the robustness and reproducibility of the efficacy signal.

At the same time, initial results from the expanded access experience in tumor-related hyperinsulinism point to a reasonable probability that the ongoing Phase 3 upLIFT trial in that indication could succeed on its current primary endpoint, which led Zhong to raise the price target modestly by reintroducing tumor HI into the valuation with a risk-adjusted probability of success. However, the regulatory implications of the sunRIZE outcome for the broader congenital HI program remain unsettled, and Rezolute plans to meet with the FDA in the first quarter of 2026 to clarify the development and approval pathway under the existing Breakthrough Therapy designation. Given the mixed clinical picture—some encouraging activity offset by missed endpoints and a high placebo effect—and the lack of visibility on FDA’s stance, Zhong continues to exclude congenital HI from the valuation and maintains a neutral stance on the stock. This combination of promising but uncertain prospects, along with the need for further regulatory clarity, underpins the decision to reiterate a Hold rather than recommend more aggressive positioning in Rezolute shares.

In another report released today, TipRanks – OpenAI also reiterated a Hold rating on the stock with a $2.00 price target.