---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-029047"
form_type: "8-K"
ticker: "MIST"
cik: "0001408443"
company_name: "Milestone Pharmaceuticals Inc."
filed_at: "2025-03-28T23:59:59+00:00"
generated_at: "2026-05-24T02:57:08.046020+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# FDA issues Complete Response Letter for etripamil PSVT NDA; no clinical issues raised

## Summary
- CRL focuses on CMC: additional nitrosamine impurity data and facility inspection required.
- No clinical safety or efficacy concerns cited by FDA for CARDAMYST (etripamil) nasal spray.
- Company plans to request a Type A meeting with FDA to discuss resubmission path.
- Cash, cash equivalents and short-term investments of $69.7M as of Dec 31, 2024.
- CEO expresses disappointment but remains committed to the program.

## SEC filing metadata
- accession: 0001104659-25-029047
- form_type: 8-K
- ticker: MIST
- cik: 0001408443
- company_name: Milestone Pharmaceuticals Inc.
- filed_at: 2025-03-28T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1408443/000110465925029047/0001104659-25-029047-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1408443/000110465925029047/tm2510765d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-029047
- JSON: https://secwatch.observer/filing/0001104659-25-029047.json
- Plain text: https://secwatch.observer/filing/0001104659-25-029047.txt

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