---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-23-017914"
form_type: "8-K"
ticker: "DMAC"
cik: "0001401040"
company_name: "DiaMedica Therapeutics Inc."
filed_at: "2023-06-21T23:59:59+00:00"
generated_at: "2026-06-13T19:52:44.195531+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA lifts clinical hold on DiaMedica's DM199 phase 2/3 stroke trial; resumption planned

## Summary
- FDA removed clinical hold on ReMEDy2 trial studying DM199 for acute ischemic stroke.
- Protocol amendment includes reduced IV dose of DM199 and additional safety measures against severe hypotension.
- Primary endpoint changed to modified Rankin Scale (mRS) at day 90; secondary endpoints include mRS shift, death, NIHSS, Barthel Index.
- Trial to enroll ~350 patients at ~75 U.S. sites; excludes tPA and mechanical thrombectomy patients.
- CEO Rick Pauls and CMO Kirsten Gruis comment on re-engaging study sites.

## SEC filing metadata
- accession: 0001437749-23-017914
- form_type: 8-K
- ticker: DMAC
- cik: 0001401040
- company_name: DiaMedica Therapeutics Inc.
- filed_at: 2023-06-21T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1401040/000143774923017914/0001437749-23-017914-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1401040/000143774923017914/dmtp20230620_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-23-017914
- JSON: https://secwatch.observer/filing/0001437749-23-017914.json
- Plain text: https://secwatch.observer/filing/0001437749-23-017914.txt

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