regulatory
confidence high
sentiment positive
materiality 0.60
DiaMedica provides DM199 preeclampsia update after FDA pre-IND meeting; additional rabbit study required
DiaMedica Therapeutics Inc.
- 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.