secwatch.observer — SEC 8-K summary
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Issuer:     Milestone Pharmaceuticals Inc. (MIST)
CIK:        0001408443
Form:       8-K
Filed at:   2025-12-15T23:59:59+00:00
Accession:  0001104659-25-120904
Event type: regulatory
Sentiment:  positive
Materiality: 0.90
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Milestone receives FDA approval for CARDAMYST (etripamil) nasal spray for PSVT
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- FDA approved CARDAMYST (etripamil) on Dec 12, 2025 for self-administration in adults with PSVT; first new treatment in 30+ years.
- Phase 3 RAPID: 64% converted to sinus rhythm within 30 min vs 31% placebo (HR=2.62, p<0.001); median time 17 min vs 54 min.
- Product expected in retail pharmacies Q1 2026; company well-capitalized for launch with existing capital and royalty financing.
- FDA approval enables AFib-RVR development under sNDA pathway; Phase 3 program planned.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1408443/000110465925120904/0001104659-25-120904-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1408443/000110465925120904/tm2533390d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-120904

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