Core Insights - Milestone Pharmaceuticals has received FDA approval for CARDAMYST™ (etripamil) nasal spray, marking the first new treatment for paroxysmal supraventricular tachycardia (PSVT) in over 30 years, providing a self-administered option for over two million Americans with this condition [1][4][12] Company Overview - Milestone Pharmaceuticals is a biopharmaceutical company focused on developing innovative cardiovascular medicines, with CARDAMYST being its lead product aimed at treating PSVT [27] Product Details - CARDAMYST is a rapid-acting calcium channel blocker designed for the conversion of acute symptomatic episodes of PSVT to sinus rhythm in adults, allowing patients to manage episodes independently [3][14] - The product is expected to be available in retail pharmacies in the first quarter of 2026 [1] Clinical Data - The FDA approval is supported by a clinical trial program involving over 1,800 participants and more than 2,000 PSVT episodes, demonstrating that CARDAMYST users were twice as likely to convert to sinus rhythm compared to placebo [6][7] - In the Phase 3 RAPID trial, 64% of participants using CARDAMYST converted to sinus rhythm within 30 minutes, compared to 31% for placebo, with a median conversion time of 17 minutes for CARDAMYST versus 54 minutes for placebo [6][7] Market Potential - The approval of CARDAMYST opens the door for further development of etripamil for atrial fibrillation with rapid ventricular rate (AFib-RVR) under a supplemental New Drug Application (sNDA) pathway, targeting an estimated market of three to four million patients by 2030 [4][10][13] Financial Position - As of September 30, 2025, Milestone had cash and equivalents of $82.6 million, positioning the company well for the launch and commercialization of CARDAMYST [22] - The company has entered into a Royalty Purchase Agreement to secure additional funding contingent upon the FDA approval of etripamil [22][23]