Milestone® Pharmaceuticals Inc. (NASDAQ:MIST) a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced financial results for the first quarter ending March 31, 2026, and provided corporate and regulatory updates.
"We're excited to report on our first quarter of sales for CARDAMYST for paroxysmal supraventricular tachycardia, or PSVT. Healthcare professionals' initial reaction to the product is positive and we are very encouraged by the early breadth of unique prescribers writing for their patients," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "Gaining Express Scripts' national formulary coverage in March reflects meaningful early payor adoption, highlighting the value CARDAMYST offers to insurers. We are also observing clinician enthusiasm for expanded development of etripamil in patients with AFib-RVR, as we have now kicked off our Phase 3 pivotal trial and are actively engaging potential clinical trial sites."
Launch Progress for CARDAMYST
- Promotional launch for CARDAMYST™ (etripamil) nasal spray was initiated in mid-February 2026. The product was commercialized within approximately eight weeks of U.S. Food and Drug Administration (FDA) approval, including a 60-person national sales force engaging primarily with cardiologists, electrophysiologists and advanced practice providers in an office-based setting.
- A total of approximately 600 scripts for CARDAMYST have been filled for 560 patients with PSVT through April.
- Approximately 400 unique prescribers have started patients on CARDAMYST.
- Over 25% of commercially insured lives in the U.S. now have coverage for CARDAMYST.
- Express Scripts added CARDAMYST nasal spray to its commercial national formularies, effective March 27, 2026. This inclusion made CARDAMYST broadly accessible and more affordable for their commercially insured lives across the United States.
- Etripamil global expansion advancing in Europe and China.
- The marketing authorization application (MAA) for etripamil nasal spray in PSVT was accepted for review by the European Medicines Agency (EMA).The MAA incorporates the global clinical data package that supported the FDA approval of etripamil for the treatment of PSVT. TACHYMIST™ is the conditionally approved brand name for etripamil nasal spray in Europe. A European decision on approval is expected by the first half of 2027.
- Separately, in March 2026, Everest Medicines announced it had acquired the rights from the Company's China licensing partner, Corxel Pharmaceuticals to develop, manufacture, and commercialize CARDAMYST in Greater China, including Chinese Mainland, Hong Kong, Macao and Taiwan regions. In China, the New Drug Application (NDA) for etripamil nasal spray was accepted by the National Medical Products Administration (NMPA) on January 17, 2025.
- The marketing authorization application (MAA) for etripamil nasal spray in PSVT was accepted for review by the European Medicines Agency (EMA).The MAA incorporates the global clinical data package that supported the FDA approval of etripamil for the treatment of PSVT. TACHYMIST™ is the conditionally approved brand name for etripamil nasal spray in Europe. A European decision on approval is expected by the first half of 2027.
Clinical Updates and Presentations
- Details on RESET-PSVT, a planned Phase 4, multicenter, prospective, observational registry intended to generate real-world evidence on the use of CARDAMYST in adults with PSVT were presented at the Preventive Cardiovascular Nurses Association (PCNA) 2026 Cardiovascular Nursing Symposium in Scottsdale, Ariz. The study will be led by the Duke Clinical Research Institute (DCRI).
- "Minimal Blood Pressure Effects of Intranasal Etripamil for PSVT" was presented at the American College of Cardiology (ACC) Annual Scientific Session in New Orleans. The presentation summarizes analysis of mean heart rate and blood pressure changes measured during clinical trials of CARDAMYST. The results demonstrate minimal blood pressure reductions during test dose and rare symptoms consistent with hypotension, supporting the potential safe self-administration of CARDAMYST for PSVT treatment.
- "Reduction in Health Care Utilization & Emergency Department Visits with Acutely Self-Administered Etripamil for SVT: Study Data" was presented at the Stanford BioDesign Arrhythmia Technologies Meeting held prior to HRS.2026 in Chicago, Ill. Data were described on the level and growth in U.S. healthcare burden from PSVT along with relevant data from the CARDAMYST development program.
Etripamil for Patients with Atrial Fibrillation with Rapid Ventricular Rate (AFib-RVR)
- Phase 3 program in AFib-RVR now initiated. The Company has initiated a Phase 3 registrational program to evaluate self-administered etripamil as a potential treatment for patients with AFib-RVR, and is currently onboarding clinical sites. The Company expects to enroll the first patient in the trial in the second half of 2026. The Company 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 single Phase 3 study in AFib-RVR.
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