secwatch.observer — SEC 8-K summary
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Issuer:     Rezolute, Inc. (RZLT)
CIK:        0001509261
Form:       8-K
Filed at:   2024-05-24T23:59:59+00:00
Accession:  0001104659-24-065073
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Rezolute reports positive Phase 2 results for RZ402 in DME; CST reduced up to ~50 microns
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- Phase 2 study of 94 DME patients met primary endpoints: CST reduction (p=0.02) and good safety profile.
- CST improvement up to ~50 microns; 200 mg dose showed largest response; sub-analysis at CST ≥400 showed ~75 micron improvement.
- RZ402 safe and well-tolerated; AEs mild and comparable to placebo; no ocular adverse effects typical of intravitreal injections.
- No significant BCVA improvement, consistent with study duration; five 200 mg patients (20%) had 1-step DRSS improvement.
- Target concentrations exceeded at all three doses (50, 200, 400 mg) supporting once-daily oral dosing.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1509261/000110465924065073/0001104659-24-065073-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1509261/000110465924065073/tm2415552d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-24-065073

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