---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-23-015488"
form_type: "8-K"
ticker: "DMAC"
cik: "0001401040"
company_name: "DiaMedica Therapeutics Inc."
filed_at: "2023-05-22T23:59:59+00:00"
generated_at: "2026-06-14T18:07:39.738641+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# DiaMedica files clinical hold response with FDA for ReMEDy2 trial of DM199 in AIS

## Summary
- Filed complete clinical hold response with FDA on May 19, 2023 to lift hold on Phase 2/3 ReMEDy2 trial of DM199 for acute ischemic stroke.
- Protocol amendment includes reduced IV dose of DM199 and additional measures to reduce risk of severe hypotension in participants.
- Investor presentation on ReMEDy2 status furnished as Exhibit 99.1 for use at conferences and meetings.
- No FDA decision timeline disclosed; clinical hold remains in effect pending review.

## SEC filing metadata
- accession: 0001437749-23-015488
- form_type: 8-K
- ticker: DMAC
- cik: 0001401040
- company_name: DiaMedica Therapeutics Inc.
- filed_at: 2023-05-22T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1401040/000143774923015488/0001437749-23-015488-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1401040/000143774923015488/dmtp20230522_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-23-015488
- JSON: https://secwatch.observer/filing/0001437749-23-015488.json
- Plain text: https://secwatch.observer/filing/0001437749-23-015488.txt

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