---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-111088"
form_type: "8-K"
ticker: "MIST"
cik: "0001408443"
company_name: "Milestone Pharmaceuticals Inc."
filed_at: "2023-10-24T23:59:59+00:00"
generated_at: "2026-06-09T13:49:50.352368+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Milestone files NDA for etripamil; Phase 3 showed 2x efficacy, 3x speed vs placebo

## Summary
- Submitted NDA to FDA for etripamil (CARDAMYST) for paroxysmal supraventricular tachycardia (PSVT) on Oct 24, 2023.
- Pivotal Phase 3 RAPID trial published in The Lancet; etripamil restored normal rhythm 2x more effectively and 3x faster than placebo.
- FDA 60-day filing review period to determine completeness; if accepted, standard 10-month review expected.
- Brand name CARDAMYST conditionally approved by FDA; commercial preparations underway for anticipated launch.

## SEC filing metadata
- accession: 0001104659-23-111088
- form_type: 8-K
- ticker: MIST
- cik: 0001408443
- company_name: Milestone Pharmaceuticals Inc.
- filed_at: 2023-10-24T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1408443/000110465923111088/0001104659-23-111088-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1408443/000110465923111088/tm2329058d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-111088
- JSON: https://secwatch.observer/filing/0001104659-23-111088.json
- Plain text: https://secwatch.observer/filing/0001104659-23-111088.txt

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