---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-059671"
form_type: "8-K"
ticker: "MIST"
cik: "0001408443"
company_name: "Milestone Pharmaceuticals Inc."
filed_at: "2025-06-16T23:59:59+00:00"
generated_at: "2026-05-19T06:12:15.979099+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Milestone submits CRL response for CARDAMYST (etripamil) PSVT NDA after Type A meeting

## Summary
- Submitted CRL response to FDA on June 16, 2025, following a productive Type A meeting.
- FDA will determine acceptance and set PDUFA date within 30 days.
- Review timeline expected to be 2 or 6 months depending on classification.
- CARDAMYST, if approved, would be the first self-administered therapy for acute PSVT episodes.

## SEC filing metadata
- accession: 0001104659-25-059671
- form_type: 8-K
- ticker: MIST
- cik: 0001408443
- company_name: Milestone Pharmaceuticals Inc.
- filed_at: 2025-06-16T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1408443/000110465925059671/0001104659-25-059671-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1408443/000110465925059671/tm2518093d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-059671
- JSON: https://secwatch.observer/filing/0001104659-25-059671.json
- Plain text: https://secwatch.observer/filing/0001104659-25-059671.txt

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