Milestone activates sites for Phase 3 AFib-RVR trial, reports $170.6M cash

Milestone Pharmaceuticals reported on August 12, 2026 that its Phase 3 registrational trial in atrial fibrillation with rapid ventricular rate (AFib-RVR) is now open and enrolling patients, with several sites activated and evaluating patients for enrollment.¹ The company said previously announced plans to enroll the first patient in the second half of 2026 remain on track.¹ Milestone said it intends to follow the supplemental New Drug Application (sNDA) regulatory approval pathway and expects to leverage the initial PSVT indication and its safety database along with the results from the planned Phase 3 study in AFib-RVR.¹

On the regulatory side for its approved product, Milestone said regulatory review of the marketing authorization application for etripamil for PSVT in Europe remains on track for a decision from the European Medicines Agency (EMA) in the first half of 2027.¹ In China, the New Drug Application for etripamil for PSVT is currently under review by the National Medical Products Administration, with partner Everest Medicines responsible for engagement with the agency.¹

For CARDAMYST commercialization, the company said more than 800 unique prescribers had started patients on CARDAMYST through June 30, compared to approximately 200 at the end of the first quarter.¹ It also said commercial lives covered remained relatively unchanged through the second quarter at approximately 25%, but grew to approximately 50% as of the report date following formulary coverage decisions from UnitedHealthcare and other insurers.¹

On finances, Milestone reported cash, cash equivalents, and short-term investments of $170.6 million as of June 30, 2026, compared to $106.0 million as of December 31, 2025.¹ The company said this is expected to be sufficient to cover operating expenses and capital expenditures into the second half of 2027.¹