---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-22-016730"
form_type: "8-K"
ticker: "DMAC"
cik: "0001401040"
company_name: "DiaMedica Therapeutics Inc."
filed_at: "2022-07-06T23:59:59+00:00"
generated_at: "2026-06-24T20:38:49.617991+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA clinical hold on DiaMedica's ReMEDy2 trial for DM199 after 3 hypotension events

## Summary
- FDA placed clinical hold on Phase 2/3 ReMEDy2 trial of DM199 for acute ischemic stroke after 3 SAEs of transient hypotension.
- Hypotension occurred shortly after IV dose; blood pressure recovered within minutes of stopping infusion; no injuries.
- Company attributes events to different IV bag materials causing higher drug absorption vs. prior ReMEDy1 trial.
- Plans to submit revised protocol with proportionate DM199 dose reduction and shorter infusion times to FDA.
- No further enrollment until FDA reviews analysis and proposed modifications and lifts the hold.

## SEC filing metadata
- accession: 0001437749-22-016730
- form_type: 8-K
- ticker: DMAC
- cik: 0001401040
- company_name: DiaMedica Therapeutics Inc.
- filed_at: 2022-07-06T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1401040/000143774922016730/0001437749-22-016730-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1401040/000143774922016730/dmtp20220706_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-22-016730
- JSON: https://secwatch.observer/filing/0001437749-22-016730.json
- Plain text: https://secwatch.observer/filing/0001437749-22-016730.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.