secwatch.observer — SEC 8-K summary
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Issuer:     Milestone Pharmaceuticals Inc. (MIST)
CIK:        0001408443
Form:       8-K
Filed at:   2026-01-06T23:59:59+00:00
Accession:  0001104659-26-001099
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Milestone Pharma announces EMA acceptance of MAA for etripamil in PSVT; decision expected Q1 2027
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- EMA accepted Marketing Authorization Application for etripamil nasal spray (TACHYMIST) for PSVT; decision expected Q1 2027.
- Phase 3 RAPID trial: 64% conversion to sinus rhythm at 30 min vs 31% placebo (p<0.001); median time 17 min vs 54 min.
- Drug is conditionally approved brand name TACHYMIST in Europe; ~2 million PSVT patients in Europe.
- MAA includes global clinical data that supported U.S. FDA approval of etripamil for PSVT.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1408443/000110465926001099/0001104659-26-001099-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1408443/000110465926001099/tm261989d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-001099

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