MIST Stock Falls 66% Following Complete Response Letter for Cardamyst [Yahoo! Finance]
Milestone Pharmaceuticals Inc. - Common Shares (MIST)
Last milestone pharmaceuticals inc. - common shares earnings: 3/6 07:00 am
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Source: Yahoo! Finance
This drug is being developed for the treatment of paroxysmal supraventricular tachycardia (PSVT), a condition characterized by sudden, rapid heartbeats. While the CRL raises no concerns about the clinical safety or efficacy of etripamil, it points to two key Chemistry, Manufacturing, and Controls (“CMC”) issues that must be addressed before approval can be granted. Shares of MIST plunged 66.2% since the CRL issuance, reflecting the delay in the launch of Cardamyst. The company's shares have lost 67.8% so far this year against the industry's 2.2% growth. The S&P 500 Index has declined 5.6% in the same period. Image Source: Zacks Investment Research The first issue highlighted by the FDA pertains to nitrosamine impurities. The agency has requested additional data based on newly issued draft guidance that was published after MIST's NDA submission. Nitrosamines, which can pose carcinogenic risks when present above acceptable levels over prolonged exposure, have become an increasin
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MIST
News
- Milestone Pharmaceuticals (NASDAQ:MIST) was upgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=MIST&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">WallMarketBeat
- Aptar's Bidose Nasal System Delivers CARDAMYST™ (etripamil), the First and Only Self-Administered FDA-Approved Nasal Spray for Paroxysmal Supraventricular Tachycardia (PSVT) [Yahoo! Finance]Yahoo! Finance
- Milestone Pharmaceuticals upgraded to Buy at TD Cowen after Cardamyst approval [Yahoo! Finance]Yahoo! Finance
- Milestone Pharmaceuticals (NASDAQ:MIST) had its "overweight" rating reaffirmed by analysts at Wells Fargo & Company.MarketBeat
- Milestone Pharmaceuticals (MIST): Taking Stock of Valuation After FDA Approval of CARDAMYST Nasal Spray [Yahoo! Finance]Yahoo! Finance
MIST
Earnings
- 11/12/25 - Beat
MIST
Sec Filings
- 12/15/25 - Form 8-K
- 12/11/25 - Form 4
- 11/14/25 - Form SCHEDULE
- MIST's page on the SEC website