Milestone Starts Pivotal Phase 3 Trial for Etripamil in AFib-RVR
MIST is trading near its 52-week low of $1 (6.0% above the low).
Summary
Milestone has enrolled the first patient in ReVeRA-301, a Phase 3 trial testing etripamil nasal spray for atrial fibrillation with rapid ventricular rate (AFib-RVR). The trial uses the same 70 mg repeat-dose regimen already FDA-approved for PSVT as CARDAMYST. With ~150 patients and a primary endpoint of ventricular rate reduction within 30 minutes, the company is pursuing a single-study sNDA pathway. This expands the addressable market beyond PSVT into a large unmet need—30-40% of AFib patients experience RVR episodes requiring urgent care. Positive Phase 2 data showed etripamil reduced ventricular rate and improved symptoms. The trial's event-driven design and global site activation suggest a multi-year timeline, but initiation is a key de-risking step for the pipeline. Follows the Q2 update showing CARDAMYST launch momentum with over 800 prescribers.
At the time of this announcement, MIST was trading at $1.06 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $128.2M. The 52-week trading range was $1.00 to $3.06. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: GlobeNewswire.