---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-048160"
form_type: "8-K"
ticker: "MIST"
cik: "0001408443"
company_name: "Milestone Pharmaceuticals Inc."
filed_at: "2025-05-14T23:59:59+00:00"
generated_at: "2026-05-21T08:15:15.850818+00:00"
event_type: "earnings"
sentiment: "negative"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Milestone Pharma Q1 net loss $20.8M; CRL issues unresolved; Type A meeting requested

## Summary
- Q1 net loss $20.8M vs $10.4M YoY; no revenue; cash $56.0M down from $69.7M.
- FDA CRL for CARDAMYST (etripamil) in PSVT cites nitrosamine impurities and facility GMP issues.
- Type A meeting requested with FDA to address CMC concerns; no clinical safety/efficacy issues.
- New USPTO method-of-use patent extends etripamil IP protection to July 2042.
- Phase 3 AFib-RVR enrollment paused to prioritize CRL resolution; commercial ramp temporarily halted.

## SEC filing metadata
- accession: 0001104659-25-048160
- form_type: 8-K
- ticker: MIST
- cik: 0001408443
- company_name: Milestone Pharmaceuticals Inc.
- filed_at: 2025-05-14T23:59:59+00:00
- event_type: earnings
- sentiment: negative
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1408443/000110465925048160/0001104659-25-048160-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1408443/000110465925048160/tm2515019d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-048160
- JSON: https://secwatch.observer/filing/0001104659-25-048160.json
- Plain text: https://secwatch.observer/filing/0001104659-25-048160.txt

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