FDA Tells Rezolute To Request Pre-BLA Meeting On Ersodetug, But Won't Say If It's Approvable

Rezolute said Monday in an 8-K filing that the FDA encouraged it to request a pre-BLA meeting for ersodetug in congenital hyperinsulinism, a step toward filing for approval. The agency made that recommendation even though the sunRIZE trial missed its goals, and it explicitly declined to say whether the drug is approvable.

What the filing says

The FDA first did a preliminary review of detailed sunRIZE data, the company said. It then recommended a Type B pre-BLA meeting, a precursor to submitting a biologics license application, the approval request for a biologic drug.

The release says the agency's encouragement came "despite the trial's failure to meet the prespecified primary and key secondary endpoints." The FDA also noted that any approvability decision would come only during a formal BLA review.

The trial missed its main goal because the reduction in hypoglycemia events, measured by finger-stick blood glucose, was not statistically significant versus placebo. The key secondary measure, time in hypoglycemia by continuous glucose monitoring, also missed in the Week 24 evaluable window. The company said consistent and clinically relevant improvements appeared on that and several other monitor-based measures in both treatment arms.

The open-label extension is ongoing with a high retention rate. Treatment duration runs from about nine months to well over two years, the company said.

How the meeting came about

At a March 2026 Type B meeting, the FDA acknowledged the behavioral challenges of running trials in this patient group and the limits of finger-stick measures. It asked Rezolute for its continuous-glucose-monitor data.

In June 2026, the company submitted source and analysis datasets plus results from many pre-specified, post-hoc and sensitivity analyses. The agency has now reviewed them.

What it changes, and what to watch

Nothing is approved or promised. The company's own forward-looking statements warn there is no assurance the FDA will find the evidence shows a clinically meaningful benefit. The FDA could require new data, including a new randomized trial similar to sunRIZE, which the company said would hurt the timing and feasibility of approval and the drug's commercial potential.

CEO Nevan Charles Elam said the company is "encouraged by the Agency's recognition that this data will require in-depth evaluation during a formal BLA review."

Rezolute will set its BLA strategy, potentially for both congenital and tumor hyperinsulinism, after the upLIFT trial reports topline results. The company said those results remain on track for this quarter. A second pre-BLA meeting for the tumor indication is possible if the data support a filing.

The next datapoint is upLIFT's topline readout, due this quarter, which will decide whether Rezolute pursues one BLA or two.

Sources

• 8-K Filing — Rezolute, Inc. (RZLT) — SEC EDGAR
• Exhibit tm2626976d1_ex99-1.htm — Rezolute, Inc. 8-K exhibit — SEC EDGAR
• Rezolute Announces FDA Recommendation to Hold a Pre-BLA — globenewswire.com