DiaMedica Therapeutics confirmed that it completed a productive in‑person pre‑IND meeting with the U.S. Food and Drug Administration on December 18, 2025, for its lead candidate DM199 in the early‑onset preeclampsia program. The FDA’s primary request is a single additional non‑clinical study—a 10‑day modified embryo‑fetal development (EFD) and pre‑ and postnatal development (PPND) assessment in a rabbit model. The company has already begun preparing the study, with results slated for release in the second quarter of 2026.
The FDA’s request underscores the agency’s focus on safety in a pregnancy indication. By requiring a rabbit EFD/PPND study, the agency seeks confirmation that DM199, a recombinant human tissue kallikrein‑1 (rhKLK1), does not cross the placental barrier and poses no fetal risk. Successful completion of this study will provide the regulatory clarity needed to file an IND for a U.S. Phase 2 trial, a critical step toward commercial approval.
Parallel to the regulatory milestone, DiaMedica’s investigator‑sponsored Phase 2 trial in South Africa has enrolled more than 30 women with late‑stage preeclampsia. Interim data show significant reductions in maternal blood pressure and improved uterine artery Doppler indices, with no detectable placental transfer of DM199. These findings reinforce the drug’s mechanism of action—activation of bradykinin‑2 receptors to promote vasodilation and nitric oxide production—while addressing the unmet need for disease‑modifying therapy in preeclampsia.
Financially, DiaMedica reported approximately $55.3 million in cash and cash equivalents as of September 30, 2025, giving the company a runway into the second half of 2027. The company’s Q3 2025 earnings reflected a net loss of $8.6 million, driven largely by higher non‑cash share‑based compensation and personnel costs. Despite the loss, the cash position supports continued investment in the DM199 pipeline and the planned rabbit study.
Analysts remain cautiously optimistic. Consensus estimates for the upcoming U.S. Phase 2 filing are tempered by the additional study requirement, but the strong interim data and the company’s solid cash base suggest a favorable outlook for DM199’s development trajectory.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.