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DiaMedica Says FDA Seeks Additional Study Ahead of Pre-IND Submission for Preeclampsia Treatment
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DiaMedica Says FDA Seeks Additional Study Ahead of Pre-IND Submission for Preeclampsia Treatment
Mar 10, 2026 10:53 PM

10:44 AM EST, 12/18/2025 (MT Newswires) -- DiaMedica Therapeutics ( DMAC ) said Thursday that the US Food and Drug Administration has asked the company to undertake an additional study before submitting an investigational new drug application for its preeclampsia treatment candidate, DM199.

Minutes from a pre-investigational new drug meeting with the FDA showed the request for one additional non-clinical, 10-day modified embryo-fetal development and pre- and postnatal development study in a rabbit model.

DiaMedica said preparations for the study have begun, with results expected by Q2 2026.

Shares of DiaMedica were down 1.7% in recent trading.

Price: 8.07, Change: -0.14, Percent Change: -1.71

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