secwatch.observer — SEC 8-K summary
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Issuer:     Rezolute, Inc. (RZLT)
CIK:        0001509261
Form:       8-K
Filed at:   2025-02-04T23:59:59+00:00
Accession:  0001104659-25-009180
Event type: other_material
Sentiment:  neutral
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Rezolute DMC clears ersodetug open-label arm in infants; interim analysis expected Q1 2025
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- DMC reviewed 8 infants (3mo-1yr) on 5/10 mg/kg bi-weekly/monthly: safe, target concentrations reached.
- Infants may now enroll in double-blind placebo-controlled portion of sunRIZE Phase 3 study.
- Enrollment completion expected Q2 2025 pending interim analysis; topline results Q4 2025 if no change.
- Interim analysis end of Q1 2025; three outcomes: futility, continue as is, or increase sample size by 33% (18 pts).
- If sample size increased, enrollment shifts to Q4 2025, topline results to mid-2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1509261/000110465925009180/0001104659-25-009180-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1509261/000110465925009180/tm255467d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-009180

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