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DiaMedica Therapeutics Provides DM199 Preeclampsia Program Update Following Pre-IND Meeting with FDA
MINNEAPOLIS, December 18, 2025--DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company developing novel treatments for preeclampsia (PE), fetal growth restriction (FGR) and acute ischemic stroke (AIS), today announced completion of a productive in-person pre-IND meeting with the United States Food and Drug Administration (FDA) for a planned study evaluating DM199 in preeclampsia. Minutes from the meeting affirmed the FDA’s request for one additional non-clinical,
About this update from Diamedica Therapeutics Inc.
[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":2000,"height":631,"url":"https://media.zenfs.com/en/business-wire.com/470bbd0a82c426353063992d8b4ac79f"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/vKYd01RlAkAxOckEwthRig--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTMwMztjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/470bbd0a82c426353063992d8b4ac79f","width":960,"height":303},"lightbox":{"url":"https://s.yimg.com/ny/api/res/1.2/hGUAPwyBRGjfCpywMtZytw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTI0MDA7aD03NTg7Y2Y9d2VicA--/https://media.zenfs.com/en/business-wire.com/470bbd0a82c426353063992d8b4ac79f","width":1200,"height":379}},"lazy":false},{"type":"text","content":"MINNEAPOLIS, December 18, 2025--(BUSINESS WIRE)--DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company developing novel treatments for preeclampsia (PE), fetal growth restriction (FGR) and acute ischemic stroke (AIS), today announced completion of a productive in-person pre-IND meeting with the United States Food and Drug Administration (FDA) for a planned study evaluating DM199 in preeclampsia. Minutes from the meeting affirmed the FDA’s request for one additional non-clinical, 10-day modified embryo-fetal development (EFD) and pre- and postnatal development (PPND) study in a rabbit model. Preparations for this study have commenced, and results are expected to be available by the second quarter of 2026.","length":746,"tagName":"p"},{"type":"text","content":""We believe the meeting minutes provide important regulatory clarity on our non-clinical package as we prepare to submit an IND for the study of DM199 in patients with early-onset preeclampsia," said Rick Pauls, President and CEO of DiaMedica. "We look forward to ongoing engagement with the FDA as we advance efforts to develop a novel treatment for women suffering from this devastating condition, which is one of the leading causes of maternal and neonatal morbidity and mortality worldwide."","length":515,"tagName":"p"},{"type":"text","content":""The ongoing Phase 2 investigator-sponsored trial of DM199 in South Africa has now dosed over 30 women with late-stage PE. Interim data show encouraging safety and efficacy signals, including statistically significant reductions in blood pressure a...