secwatch.observer — SEC 8-K summary
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Issuer:     Milestone Pharmaceuticals Inc. (MIST)
CIK:        0001408443
Form:       8-K
Filed at:   2023-11-13T23:59:59+00:00
Accession:  0001104659-23-116598
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Milestone's etripamil Phase 2 meets primary endpoint; 30 bpm ventricular rate reduction vs placebo
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- Mean ventricular rate reduction of 29.91 bpm vs placebo (p<0.0001); absolute max reduction 35 bpm etripamil vs 5 bpm placebo.
- 58.3% of etripamil patients achieved <100 bpm vs 4% placebo; median time to max reduction 13 min, effect ~150 min.
- TSQM-9 patient-reported symptom relief significantly improved: effectiveness (p<0.0001) and relief of symptoms (p=0.0002).
- Safety consistent with PSVT program; SAEs rare: one patient with transient severe bradycardia/syncope resolved.
- Company plans Phase 3 trial; NDA for etripamil in PSVT already submitted with FDA.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1408443/000110465923116598/0001104659-23-116598-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1408443/000110465923116598/tm2330492d2_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-23-116598

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