secwatch.observer — SEC 8-K summary
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Issuer:     DiaMedica Therapeutics Inc. (DMAC)
CIK:        0001401040
Form:       8-K
Filed at:   2022-07-06T23:59:59+00:00
Accession:  0001437749-22-016730
Event type: regulatory
Sentiment:  negative
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1401040/000143774922016730/0001437749-22-016730-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1401040/000143774922016730/dmtp20220706_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-22-016730

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer