secwatch.observer — SEC 8-K summary
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Issuer:     Rezolute, Inc. (RZLT)
CIK:        0001509261
Form:       8-K
Filed at:   2026-11-13T11:27:13+00:00
Accession:  0001104659-26-126502
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

Rezolute's Phase 3 upLIFT study of ersodetug in tumor hyperinsulinism hits primary endpoint
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- 13 of 16 participants met the ≥50% GIR reduction responder criterion, including 12 with complete IV glucose discontinuation; threshold was ≥9 responders (≥56%).
- Primary endpoint achievement based on preliminary results from a November 5, 2026 data evaluation; topline and statistical analysis expected by mid-December 2026.
- One participant discontinued early to enter home hospice and died a week later from cancer progression; classified as a non-responder.
- Enrollment: 16 participants — 4 with non-islet cell tumors and 12 with insulin-secreting malignant insulinomas; ersodetug dosed 9 mg/kg weekly for 8 weeks.
- Ersodetug well-tolerated with no drug-related safety findings; CEO Nevan Elam targets FDA discussions in Q1 2027 for congenital and tumor HI.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1509261/000110465926126502/0001104659-26-126502-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1509261/000110465926126502/tm2627558d10_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-126502

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer