Rezolute Aligns with FDA on Phase 3 Trial Design

Rezolute ( (RZLT) ) just unveiled an update.

On September 2, 2025, Rezolute, Inc. announced alignment with the FDA on a streamlined design for its ongoing Phase 3 trial of ersodetug in treating tumor hyperinsulinism. This decision, made in an August 19, 2025 meeting with the FDA, removes the need for a double-blind randomized placebo-controlled trial, focusing instead on a single-arm open-label study with as few as 16 participants. The FDA’s agreement to this approach, supported by Rezolute’s previous Expanded Access Program outcomes, is expected to expedite the development and availability of this therapy, addressing a significant unmet need in the treatment of hypoglycemia caused by tumor HI.

The most recent analyst rating on (RZLT) stock is a Buy with a $12.00 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.

Rezolute’s overall stock score is impacted by its challenging financial performance, with persistent losses and operational inefficiencies. However, technical analysis shows moderate upward momentum, and positive corporate events, including significant funding and promising clinical trial progress, offer potential upside. Valuation remains weak with negative earnings, suggesting cautious optimism for the stock’s future.

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

More about Rezolute

Rezolute, Inc. is a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI). The company’s antibody therapy, ersodetug, is designed to treat all forms of HI and has shown meaningful benefit in clinical trials and real-world use for both congenital and tumor HI.

Average Trading Volume: 1,036,685

Technical Sentiment Signal: Hold

Current Market Cap: $619.4M

Learn more about RZLT stock on TipRanks’ Stock Analysis page.