Rezolute, Inc. RZLT
Rezolute, Inc. (Nasdaq: RZLT) is an endocrine/women's health drug developer. Its lead program, Ersodetug, is in Phase 3 for Tumor hyperinsulinism (insulinoma and non-islet cell tumor hypoglycemia). Its next catalyst on record is Ersodetug (tumor HI): Topline data from registrational Phase 3 upLIFT study (December 2026).
Upcoming catalysts
- December 2026Ersodetug (tumor HI) — Topline data from registrational Phase 3 upLIFT study
topline data is expected in mid-December 2026
Next further out: Ersodetug — BLA submission to FDA (H1 2027). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Ersodetug (tumor HI) | Tumor hyperinsulinism | antibody | Phase 3 |
| Ersodetug (congenital HI) | Congenital hyperinsulinism | antibody | Phase 3 |
| RZ402 / PKI Portfolio | Paused; exploring other indications (previously diabetic macular edema) | small molecule | Phase 2 |
Recent results and decisions
- Nov 5, 2026n/a FDA recommended the Company file a BLA for ersodetug for congenital HI after a pre-BLA meeting, with submission planned for 2027.
The Agency recommended the Company file for review under a Biologics License Agreement (BLA) for congenital HI after holding a pre-BLA meeting.
Filing - Oct 29, 2026missed Phase 3 sunRIZE study primary endpoint (SMBG weekly hypoglycemia events) not met due to confounding placebo/study effect caused by functional unblinding.
Primary endpoint (SMBG weekly hypoglycemia events) not met due to confounding placebo/study effect caused by functional unblinding of the endpoint
Filing - Oct 14, 2026completed enrollment Phase 3 upLIFT (single-arm, 16 participants) is fully enrolled; 7 of the first 8 participants were responders.
Rezolute Announces Completion of Enrollment in Phase 3 upLIFT Study of Ersodetug in Tumor Hyperinsulinism
Filing
3 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 endocrine/women's health companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.