secwatch.observer — SEC 8-K summary
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Issuer:     DiaMedica Therapeutics Inc. (DMAC)
CIK:        0001401040
Form:       8-K
Filed at:   2025-12-18T23:59:59+00:00
Accession:  0001437749-25-038211
Event type: regulatory
Sentiment:  positive
Materiality: 0.60
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

DiaMedica provides DM199 preeclampsia update after FDA pre-IND meeting; additional rabbit study required
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- FDA requested one non-clinical 10-day rabbit EFD/PPND study; results expected by Q2 2026.
- Phase 2 investigator-sponsored trial in South Africa has dosed over 30 women with late-stage PE.
- Interim data: statistically significant blood pressure reductions, uterine artery dilation, no placental transfer.
- Regulatory clarity obtained for IND submission to study DM199 in early-onset preeclampsia.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1401040/000143774925038211/0001437749-25-038211-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1401040/000143774925038211/dmtp20251217_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-25-038211

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