FDA Requests Additional Data for DiaMedica’s Preeclampsia Drug DM199
Event summary
- FDA requests additional nonclinical reproductive toxicity data for DM199 (rinvecalinase alfa) to support U.S. IND application.
- DiaMedica believes existing rat study may suffice if it can demonstrate sufficient exposure, enzymatic activity, and pharmacologic effect.
- Company plans to initiate a pharmacokinetic study in rats to address FDA’s request.
- DiaMedica to initiate preeclampsia studies in Canada and the UK later in 2026.
The big picture
The FDA’s request for additional data highlights the regulatory scrutiny faced by novel therapeutic candidates. DiaMedica’s ability to navigate this feedback will be critical for advancing DM199, a recombinant form of human tissue kallikrein-1, which is also being explored for fetal growth restriction and acute ischemic stroke. The company’s parallel initiation of studies in Canada and the UK suggests a strategic pivot to mitigate U.S. regulatory delays.
What we're watching
- Regulatory Hurdles
- Whether DiaMedica can successfully demonstrate sufficient evidence of DM199 exposure and activity in rats to meet FDA requirements.
- Clinical Execution
- The pace at which DiaMedica completes the additional nonclinical studies and submits the requested information to the FDA.
- Market Strategy
- How the delay in U.S. IND filing may impact DiaMedica’s competitive positioning in the preeclampsia treatment space.
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