Milestone Pharma's CARDAMYST Launch Exceeds Expectations, EMA Accepts Application, New Phase 3 Program Planned
Summary
Milestone Pharmaceuticals reported its fourth quarter and full year 2025 financial results and provided a significant update on its CARDAMYST nasal spray. The company announced that the commercial launch of CARDAMYST for PSVT is tracking or exceeding pre-launch expectations. Crucially, the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for etripamil, with a decision anticipated by the first half of 2027. Additionally, Milestone plans to initiate a Phase 3 program for etripamil in patients with Atrial Fibrillation with Rapid Ventricular Rate (AFib-RVR). While the financial results were broadly covered in the company's 10-K filing earlier today, the positive launch performance, EMA acceptance, and new Phase 3 program represent material new information. These developments significantly expand the potential market and future revenue streams for etripamil, enhancing the company's long-term growth prospects. Investors should monitor the continued commercial uptake of CARDAMYST, progress on the EMA review, and the initiation of the AFib-RVR Phase 3 study.
At the time of this announcement, MIST was trading at $1.72 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $144.8M. The 52-week trading range was $0.63 to $3.06. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.