---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-076468"
form_type: "8-K"
ticker: "MIST"
cik: "0001408443"
company_name: "Milestone Pharmaceuticals Inc."
filed_at: "2025-08-12T23:59:59+00:00"
generated_at: "2026-05-17T14:24:45.491646+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Milestone Pharma: FDA accepts CRL response for CARDAMYST; new Dec 13 PDUFA date; Q2 net loss $13M

## Summary
- FDA accepted CRL response for CARDAMYST (etripamil) for PSVT; new PDUFA target Dec 13, 2025.
- Completed public equity offering in July, raising up to $170M gross if warrants exercised; net proceeds ~$48.7M.
- Amended royalty agreement with RTW, extending approval deadline to Dec 31, 2025 for up to $75M payment.
- Cash, cash equivalents and short-term investments $43.4M as of June 30; net loss $13M for Q2 vs $9.4M Q2 2024.
- Commercial expense increased to $5.1M in Q2 (vs $1.8M) as company maintains launch capability pending approval.

## SEC filing metadata
- accession: 0001104659-25-076468
- form_type: 8-K
- ticker: MIST
- cik: 0001408443
- company_name: Milestone Pharmaceuticals Inc.
- filed_at: 2025-08-12T23:59:59+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1408443/000110465925076468/0001104659-25-076468-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1408443/000110465925076468/tm2523169d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-076468
- JSON: https://secwatch.observer/filing/0001104659-25-076468.json
- Plain text: https://secwatch.observer/filing/0001104659-25-076468.txt

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