MINNEAPOLIS, Minn. — DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for preeclampsia, fetal growth restriction and acute ischemic stroke (AIS), today announced that it has received a No Objection Letter (NOL) from Health Canada for its Clinical Trial Application to evaluate DM199 in a Phase 2 trial in patients with early-onset preeclampsia (PE). 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.
“Health Canada’s authorization to initiate our Phase 2 clinical trial of DM199 in preeclampsia represents an important regulatory milestone for DiaMedica,” said Rick Pauls, President and Chief Executive Officer of DiaMedica Therapeutics. “This clearance allows us to launch our planned Phase 2 PE study to build upon the encouraging results observed in the investigator-sponsored trial in South Africa. We look forward to continuing our work to bring a clinically meaningful therapeutic option for women suffering from early-onset preeclampsia, a patient population with significant unmet medical need and no currently approved treatment options.”
The Phase 2 trial is an open-label, dose-ranging study evaluating DM199 as a treatment for pregnant women diagnosed with early-onset preeclampsia between 24 and 32 weeks of gestation. The study will evaluate safety, tolerability and, on an exploratory basis, early markers of efficacy after treatment with DM199, including changes in uterine artery pulsatility index, sFlt-1, placental growth factor (PGIF) and other biomarkers associated with preeclampsia, maternal and fetal complications and gestational age at delivery. The study will initially evaluate three dose levels of DM199 administered subcutaneously every three days until delivery. The study is expected to begin later this year, with expansion into the United States and United Kingdom planned following regulatory clearances.
Recent NPR coverage highlights the urgent need for new treatments for preeclampsia and underscores the promise of DM199 as a potential therapeutic approach to improve maternal outcomes, if successfully developed and approved. Read the full story here: https://www.npr.org/2026/02/14/nx-s1-5708744/preeclampsia-pregnancy-complication-treatment
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About DM199 (rinvecalinase alfa) for Preeclampsia
DM199 is a recombinant form of the human tissue kallikrein-1 protein (rhKLK1), currently in clinical development for preeclampsia, fetal growth restriction and acute ischemic stroke. KLK1 is a serine protease enzyme that plays an important role in the regulation of diverse physiological processes via a molecular mechanism that increases production of nitric oxide, prostacyclin and endothelium-derived hyperpolarizing factor. Collectively, in preeclampsia, these processes are believed to improve arterial health, including the uterine arteries, reduce blood pressure and enhance microcirculatory blood flow and tissue perfusion.
About DiaMedica Therapeutics Inc.
DiaMedica Therapeutics Inc. is a clinical stage biopharmaceutical company committed to improving the lives of people suffering from serious ischemic diseases with a focus on preeclampsia, fetal growth restriction and acute ischemic stroke. DiaMedica’s lead candidate DM199 is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality in Asia for the treatment of acute ischemic stroke, preeclampsia and other vascular diseases. For more information visit the Company’s website at www.diamedica.com.
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