Milestone FDA OK on 1st, Only Self-Administered Spray for Paroxysmal Supraventricular Tachycardia

Milestone (Nasdaq: MIST) announced FDA approval of CARDAMYST (etripamil) nasal spray for conversion of acute symptomatic paroxysmal supraventricular tachycardia (PSVT) in adults, the first FDA‑approved PSVT treatment in 30+ years for more than 2 million Americans. CARDAMYST is expected to be available in retail pharmacies in Q1 2026. Approval is supported by safety data from >1,800 participants and >2,000 PSVT episodes, including the Phase 3 RAPID trial (64% vs 31% conversion at 30 minutes; HR=2.62; p<0.001) and a median time to conversion of 17 vs 54 minutes. Milestone said it is well‑capitalized to launch using existing capital and royalty financing and is pursuing a Phase 3 program for AFib‑RVR via an sNDA pathway.

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