---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-120904"
form_type: "8-K"
ticker: "MIST"
cik: "0001408443"
company_name: "Milestone Pharmaceuticals Inc."
filed_at: "2025-12-15T23:59:59+00:00"
generated_at: "2026-05-16T13:11:33.808689+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Milestone receives FDA approval for CARDAMYST (etripamil) nasal spray for PSVT

## Summary
- 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.

## SEC filing metadata
- accession: 0001104659-25-120904
- form_type: 8-K
- ticker: MIST
- cik: 0001408443
- company_name: Milestone Pharmaceuticals Inc.
- filed_at: 2025-12-15T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1408443/000110465925120904/0001104659-25-120904-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1408443/000110465925120904/tm2533390d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-120904
- JSON: https://secwatch.observer/filing/0001104659-25-120904.json
- Plain text: https://secwatch.observer/filing/0001104659-25-120904.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.