secwatch.observer — SEC 8-K summary
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Issuer:     DiaMedica Therapeutics Inc. (DMAC)
CIK:        0001401040
Form:       8-K
Filed at:   2023-06-21T23:59:59+00:00
Accession:  0001437749-23-017914
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1401040/000143774923017914/0001437749-23-017914-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1401040/000143774923017914/dmtp20230620_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-23-017914

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