secwatch.observer — SEC 8-K summary
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Issuer:     Milestone Pharmaceuticals Inc. (MIST)
CIK:        0001408443
Form:       8-K
Filed at:   2025-08-12T23:59:59+00:00
Accession:  0001104659-25-076468
Event type: earnings
Sentiment:  positive
Materiality: 0.85
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1408443/000110465925076468/0001104659-25-076468-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1408443/000110465925076468/tm2523169d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-076468

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