Milestone Pharmaceuticals (MIST) Receives FDA Response on Etripamil NDA

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Mar 28, 2025
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Milestone Pharmaceuticals Inc. (MIST, Financial) recently received a Complete Response Letter (CRL) from the U.S. FDA concerning its New Drug Application for CARDAMYST™ (etripamil) nasal spray, which targets acute PSVT episodes. While the FDA noted no clinical safety or efficacy issues, it highlighted two Chemistry, Manufacturing, and Controls (CMC) concerns. The company is planning a Type A meeting with the FDA to address these points. As of December 31, 2024, Milestone had $69.7 million in cash and investments.

Wall Street Analysts Forecast

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Based on the one-year price targets offered by 3 analysts, the average target price for Milestone Pharmaceuticals Inc (MIST, Financial) is $12.00 with a high estimate of $25.00 and a low estimate of $2.00. The average target implies an upside of 1,248.16% from the current price of $0.89. More detailed estimate data can be found on the Milestone Pharmaceuticals Inc (MIST) Forecast page.

Based on the consensus recommendation from 4 brokerage firms, Milestone Pharmaceuticals Inc's (MIST, Financial) average brokerage recommendation is currently 2.3, indicating "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.

Disclosures

I/We may personally own shares in some of the companies mentioned above. However, those positions are not material to either the company or to my/our portfolios.