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Milestone Pharmaceuticals Provides 2025 Corporate Outlook and Will Host Investor Event on February 25 in NYC
MISTMilestone Pharmaceuticals(MIST) GlobeNewswire News Room·2025-01-28 13:00

Core Insights - Milestone Pharmaceuticals is preparing for a transformative year in 2025 with the potential FDA approval of CARDAMYST™ (etripamil) nasal spray for Paroxysmal Supraventricular Tachycardia (PSVT) [3][8] - The company is building commercial capabilities for a targeted launch of CARDAMYST in mid-2025, pending FDA approval [8] - A Phase 3 study for etripamil in patients with atrial fibrillation with rapid ventricular rate (AFib-RVR) is set to begin in the first half of 2025 [6] Company Overview - Milestone Pharmaceuticals Inc. focuses on developing and commercializing innovative cardiovascular medicines to improve patient care [10] - Etripamil is the lead investigational product, designed as a self-administered nasal spray for managing symptomatic episodes of PSVT and AFib-RVR [7][10] Regulatory and Clinical Developments - The FDA Prescription Drug User Fee Act (PDUFA) target date for CARDAMYST is March 27, 2025, with no advisory committee planned [8] - The company has completed a Phase 3 clinical program for PSVT and a Phase 2 trial for AFib-RVR, indicating a robust clinical trial background [9] Commercial Strategy - Milestone is enhancing its commercial strategy with the hiring of key personnel, including a new VP of Sales, to prepare for the launch of CARDAMYST [8] - An investor event is scheduled for February 25, 2025, to provide updates on the commercial strategy and product launch [5][8] Upcoming Events - Assuming FDA approval, Milestone will have its first branded product presence at major medical conferences in 2025, including the American College of Cardiology annual meeting and the Heart Rhythm Society Annual Meeting [8]