DM199 (rinvecalinase alfa)

June 16, 2026: DiaMedica Therapeutics Inc. (NASDAQ: DMAC) said it received written FDA feedback on additional nonclinical reproductive toxicity data needed to support continued development of DM199 (rinvecalinase alfa) for preeclampsia and a potential U.S. IND. The FDA indicated the company’s previously completed rat reproductive toxicity study may be acceptable for an IND if DiaMedica can show DM199 exposure and enzymatic activity throughout that study and demonstrate adequate pharmacologic effect in rats to justify rats as an appropriate toxicology species. To address this, DiaMedica is initiating a rat pharmacokinetic (PK) and pharmacologic activity study and is summarizing recently completed data intended to support DM199 pharmacodynamic activity in rats. After completing the rat PK study, the company plans to submit the requested information to the FDA for review. DiaMedica also said it plans to initiate a preeclampsia study in Canada and the United Kingdom later in 2026.