secwatch.observer — SEC 8-K summary
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Issuer:     Milestone Pharmaceuticals Inc. (MIST)
CIK:        0001408443
Form:       8-K
Filed at:   2024-05-29T23:59:59+00:00
Accession:  0001104659-24-065806
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Milestone Pharma gets FDA NDA acceptance for CARDAMYST (etripamil) nasal spray for PSVT
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- FDA accepted NDA on May 26, 2024 for CARDAMYST (etripamil) nasal spray for paroxysmal supraventricular tachycardia (PSVT).
- PDUFA target date set at 10 months from acceptance (approx. March 2025).
- CEO Joseph Oliveto cites progress toward a new self-administered treatment option for PSVT patients.
- CARDAMYST clinical program represents the largest data package ever studied for acute self-management of PSVT.
- Brand name CARDAMYST is conditionally approved by FDA; commercial preparations continue for potential launch.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1408443/000110465924065806/0001104659-24-065806-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1408443/000110465924065806/tm2415708d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-24-065806

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