---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-067108"
form_type: "8-K"
ticker: "MIST"
cik: "0001408443"
company_name: "Milestone Pharmaceuticals Inc."
filed_at: "2025-07-11T23:59:59+00:00"
generated_at: "2026-05-18T06:53:46.935436+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Milestone's CRL response for CARDAMYST; new PDUFA Dec 13, 2025

## Summary
- FDA accepted Milestone's response to CRL for CARDAMYST (etripamil) nasal spray for PSVT; new PDUFA target date Dec 13, 2025.
- $75M Royalty Purchase Agreement with RTW extended; approval deadline moved from Sept 30, 2025 to Dec 31, 2025.
- CRL response submitted June 13, 2025 after FDA Type A meeting; included additional nitrosamine studies and facility transfer.
- FDA raised no concerns regarding clinical section of NDA.
- RTW proceeds expected to aid CARDAMYST commercial launch if approved.

## SEC filing metadata
- accession: 0001104659-25-067108
- form_type: 8-K
- ticker: MIST
- cik: 0001408443
- company_name: Milestone Pharmaceuticals Inc.
- filed_at: 2025-07-11T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 1.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1408443/000110465925067108/0001104659-25-067108-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1408443/000110465925067108/tm2520348d2_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-067108
- JSON: https://secwatch.observer/filing/0001104659-25-067108.json
- Plain text: https://secwatch.observer/filing/0001104659-25-067108.txt

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