Posted: 06/27/2025 03:05 am
Milestone Pharmaceuticals has been active in the news, especially around its lead investigational product, Etripamil. The company's attempt to solidify its position with a new method-of-use patent for Etripamil nasal spray, proposed under the trade name CARDAMYST™, marks a pivotal effort to manage Paroxysmal Supraventricular Tachycardia (PSVT)^2. However, their path to securing FDA approval faced an obstacle when the FDA issued a Complete Response Letter (CRL) in March 2025, focusing on chemistry, manufacturing, and control (CMC) aspects, without raising clinical safety or efficacy concerns^3.
This regulatory hiccup has influenced investor sentiment and stock performance. Indeed, following the FDA's non-approval news, Milestone's stock price witnessed a sharp 66% decline^4. Despite these challenges, MIST's outlook experienced a boost when a Zacks Rank upgrade to Buy was announced, driven by optimism towards its earnings prospects^5.
The company's current stock trades at $1.94, with a market capitalization of approximately $103.7 million^6. Although the stock's price struggles can reflect its tumultuous journey toward regulatory compliance, the continued expansion efforts in commercialization and product adaptation signal its resilience and potential for recovery. With sustained innovation and strategic financial leadership, Milestone Pharmaceuticals aims to overcome its recent setbacks and achieve long-term success in the competitive pharmaceutical landscape.
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1. Securities and Exchange Commission, Amit Hasija Compensation Data 2024, 2022, 2020
2. MILESTONE Pharmaceuticals Press Release, February 19, 2025
3. Globe Newswire, FDA Issues Complete Response Letter for Etripamil for PSVT, March 28, 2025
4. Reuters, US FDA declines to approve Milestone Pharma's heart rhythm nasal spray, March 28, 2025
5. Zacks.com, Milestone Pharmaceuticals (MIST) Upgraded to Buy, May 22, 2025
6. NASDAQ, Milestone Pharmaceuticals Stock Data, Accessed June 2025
