{"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","discovered_at":"2026-05-14T18:03:55.615407+00:00","generated_at":"2026-06-24T20:38:49.617991+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA clinical hold on DiaMedica's ReMEDy2 trial for DM199 after 3 hypotension events","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-22-016730","json":"https://secwatch.observer/filing/0001437749-22-016730.json","markdown":"https://secwatch.observer/filing/0001437749-22-016730.md","text":"https://secwatch.observer/filing/0001437749-22-016730.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-24T20:38:49.617991+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}