Maintaining a Buy on Rezolute: Clear Drug Activity, High-Need Patient Benefit, and Upcoming FDA Catalysts Support Attractive Risk-Reward

Analyst Julian Harrison of BTIG maintained a Buy rating on Rezolute, retaining the price target of $5.00.

Julian Harrison has given his Buy rating due to a combination of factors that, in his view, support the long‑term value of Rezolute. He points to additional Phase 3 sunRIZE data in congenital hyperinsulinism (cHI) indicating that intensive glucose monitoring and frequent clinical interactions may have inflated the placebo response and obscured the true treatment effect, despite clear pharmacologic and biomarker activity consistent with prior Phase 2 results. The fact that all patients who completed sunRIZE chose to continue treatment in the open‑label extension, with several children transitioning to ersodetug as monotherapy, reinforces the perceived clinical benefit. Although the study did not meet its primary endpoint and the regulatory path in cHI is not yet defined, he expects Rezolute’s upcoming FDA meeting in 1Q26 to clarify future development options, and therefore keeps his financial model conservative for now.
Harrison also emphasizes the strength of the data from the tumor hyperinsulinism expanded access program, where most patients dependent on IV dextrose or TPN were able to discontinue those therapies while on ersodetug. These results underpinned the FDA’s agreement to revise the Phase 3 upLIFT trial to a single‑arm, open‑label design with an objective and tightly controlled primary endpoint (a 50% reduction in glucose infusion rate), with data anticipated in the second half of 2026. He believes these clinical signals, combined with a risk‑adjusted net present value sum‑of‑the‑parts valuation framework, justify a favorable risk‑reward profile at current levels. In sum, Harrison sees sufficient evidence of drug activity, meaningful clinical benefit in high‑need populations, and future catalysts to support maintaining a Buy rating on Rezolute shares.

In another report released yesterday, H.C. Wainwright also reiterated a Buy rating on the stock with a $5.00 price target.

RZLT’s price has also changed dramatically for the past six months – from $4.980 to $2.350, which is a -52.81% drop .