Milestone Pharmaceuticals Inc. (MIST), a biopharmaceutical company, on Friday announced the enrollment of the first patient in the Canadian site of the Phase 3 ReVeRA-301 trial evaluating the Etripamil nasal spray for treating atrial fibrillation with rapid ventricular rate (AFib-RVR). Etripamil received approval from the U.S. Food and Drug Administration (FDA) in December 2025 and is marketed in the country as CARBAMYST. The drug is formulated as a nasal spray for treating Paroxysmal Supraventricular Tachycardia (PSVT), and was made available in retail pharmacies in January 2026, with a national sales force launched in February. A Marketing Authorization Approval (MAA) for the drug is expected from the European Medicines Agency (EMA) in mid 2027. The Phase 3 ReVeRA-301 trial is a multinational, multi-center, randomized, double-blind, placebo-controlled study that plans to enroll 150 patients of Afib-RVR. The study aims to test etripamil when administered in a 70 mg repeated daily dose at home, with the primary endpoint set at a change in ventricular rate (VR) within 30 minutes of dosing. The company plans to submit a supplemental new drug application (sNDA) for the same based on the strength of the study's results. MIST closed Friday at $0.79, down 0.82%.
For comments and feedback contact: editorial@rttnews.com
September 28, 2026 06:25 ET Every month, the FDA issues decisions on drug approvals — and for biotech investors, these dates are important milestones for the companies and patients involved. In this video, we highlight five key FDA decisions scheduled for October 2026, covering potential approvals and expanded indications across oncology, rare diseases, ophthalmology, and chronic hepatitis B.
