secwatch.observer — SEC 8-K summary
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Issuer:     Onconetix, Inc. (ONCO)
CIK:        0001782107
Form:       8-K
Filed at:   2025-03-24T23:59:59+00:00
Accession:  0001013762-25-001260
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Onconetix presents Proclarix data at EAU; 96% sensitivity, 22% biopsy avoidance in Danish cohort
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- Proclarix evaluated in 808 patients; in targeted subpopulation (n=371), negative test gave 5% csPCa probability vs 14% for %fPSA (p=0.028).
- Proclarix avoided 22% of biopsies while missing only 3 of 101 csPCa cases (2 GG2, 1 GG3).
- In extended population (n=654, PSA 2-20 ng/mL), sensitivity 96%, specificity significantly higher than %fPSA and ERSPC RC (p<0.001).
- Data presented March 23, 2025 at EAU congress in Madrid; study led by Ahmed H. Zedan, MD, PhD of Lillebaelt Hospital.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1782107/000101376225001260/0001013762-25-001260-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1782107/000101376225001260/ea0235277-8k_oncon.htm
  HTML page:      https://secwatch.observer/filing/0001013762-25-001260

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