secwatch.observer — SEC 8-K summary
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Issuer:     Milestone Pharmaceuticals Inc. (MIST)
CIK:        0001408443
Form:       8-K
Filed at:   2025-07-11T23:59:59+00:00
Accession:  0001104659-25-067108
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 1.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1408443/000110465925067108/0001104659-25-067108-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1408443/000110465925067108/tm2520348d2_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-067108

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer