secwatch.observer — SEC 8-K summary
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Issuer:     Rezolute, Inc. (RZLT)
CIK:        0001509261
Form:       8-K
Filed at:   2026-10-14T21:11:48+00:00
Accession:  0001104659-26-115874
Event type: other_material
Sentiment:  positive
Materiality: 0.60
Item codes: 7.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

Rezolute completes Phase 3 upLIFT enrollment; topline ersodetug data expected mid-December 2026
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- Phase 3 upLIFT fully enrolled 16 participants with insulinoma or non-islet cell tumors causing uncontrolled hypoglycemia; topline results expected mid-December 2026.
- Primary endpoint: at least 50% reduction from baseline in IV glucose infusion rate; responder rate must be at least 56% (95% CI 30-80%) for significance.
- 7 of the first 8 participants met the responder criterion and all 7 fully discontinued IV glucose; the eighth entered hospice and died of cancer progression, counted as a non-responder.
- Ersodetug given at 9 mg/kg weekly for 8 weeks as add-on to standard of care; well-tolerated with no drug-related safety findings reported to date.
- Company continues expanded access for compassionate use in tumor HI and sees potential to advance both indications in 2027 if outcomes are favorable.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1509261/000110465926115874/0001104659-26-115874-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1509261/000110465926115874/tm2627620d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-115874

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