DMAC News & Events

DiaMedica Therapeutics announced that it has received a no objection letter from Health Canada for its clinical trial application to evaluate DM199 in a Phase 2 trial in patients with early-onset preeclampsia. This regulatory clearance enables DiaMedica to initiate its Phase 2 study of DM199 in early-onset preeclampsia. The company plans to initiate the trial in 2026 and expand into the United States and United Kingdom as regulatory clearances are obtained.

DiaMedica Therapeutics announced the completion of a productive pre-IND meeting with the FDA for a planned study evaluating DM199 in preeclampsia. The company said minutes from the meeting affirmed the FDA's request for one additional non-clinical study in a rabbit model, with results expected by Q2 2026. DiaMedica also noted that in an ongoing Phase 2 investigator-sponsored trial in South Africa, over 30 women have been dosed, with interim data showing encouraging safety and efficacy signals.