Rezolute Updates sunRIZE Phase 3 Trial and FDA Plans

Rezolute ( (RZLT) ) has shared an announcement.

On January 7, 2025, Rezolute reported detailed observations from its Phase 3 sunRIZE trial in congenital hyperinsulinism, noting that although the study did not meet its primary and key secondary endpoints for reducing hypoglycemia events and time in hypoglycemia, data showed clear pharmacologic activity of ersodetug and reductions from baseline that were confounded by a strong placebo effect and study design factors in an ambulatory glucose-monitoring setting. The company highlighted that all 59 patients who completed the controlled phase of sunRIZE chose to continue into the open-label extension and that many children there have discontinued all other therapies and remain on ersodetug monotherapy, while Rezolute prepares to discuss the full dataset and potential regulatory path with the FDA under its Breakthrough Therapy Designation in early 2026. Rezolute also released cumulative data from the first nine tumor hyperinsulinism patients treated with ersodetug in its expanded access program over the past two years, showing that 75% of those on IV dextrose or total parenteral nutrition were able to fully discontinue these infusions, evidence that supported redesign of the Phase 3 upLIFT tumor HI trial into a single-arm, open-label study using glucose infusion rate reduction as the primary endpoint and underscored the potential of ersodetug to address severe, refractory hypoglycemia in this population.

The most recent analyst rating on (RZLT) stock is a Hold with a $2.50 price target. To see the full list of analyst forecasts on Rezolute stock, see the RZLT Stock Forecast page.

Spark’s Take on RZLT Stock

According to Spark, TipRanks’ AI Analyst, RZLT is a Neutral.

The score is held down primarily by continued pre-revenue losses and heavy cash burn, along with weak technicals (price below major moving averages and negative MACD). A low-debt balance sheet provides some support, and the recent positive program update is a modest offset, but valuation remains constrained by negative earnings and no dividend support.

To see Spark’s full report on RZLT stock, click here.

More about Rezolute

Rezolute, Inc. is a late-stage rare disease biopharmaceutical company focused on treating hypoglycemia caused by all forms of hyperinsulinism (HI). Its lead product candidate, ersodetug, is a fully human monoclonal antibody designed to allosterically modulate the insulin receptor, with potential applicability across both congenital and tumor-related HI, and has been evaluated in clinical trials as well as in real-world expanded access settings.

Average Trading Volume: 6,054,667

Technical Sentiment Signal: Sell

Current Market Cap: $182.2M

See more insights into RZLT stock on TipRanks’ Stock Analysis page.