Paroxysmal supraventricular tachycardia
MISTMilestone PharmaceuticalsCatalyst overview
Research summary
This catalyst tracks a Approved update for CARDAMYST (Etripamil) in Paroxysmal supraventricular tachycardia. The expected timing is based on the latest available company guidance and may change.
RAPID/RAPID Ext./NODE-303/NODE-301 studies. 5/29/24- NDA accepted. 11/12/24- PDUFA goal date of Mar 27, 2025. 3/28/25- Received CRL: focused on CMC, no clinical issues. 6/16/25- Submitted response to CRL. 7/11/25- FDA accepted response to CRL. 8/12/25- New PDUFA date of Dec 13, 2025. Poster presentation at AHA'25. 12/12/25:- FDA approves CARDAMYST for conversion of acute PSVT episodes; U.S. launch expected Q1 2026. 01/26/26:- CARDAMYST now available in U.S. pharmacies; national sales launch with copay assistance in mid-February 2026. 03/16/26:- ACC.26 poster March 29, 2026 reports minimal BP effects in Ph3 PSVT trials. 03/20/26:- EU MAA accepted; EMA decision expected H1 2027. ACC 2026 blood pressure poster March 30 supports safe self-administration. 04/10/26:- RESET-PSVT Phase 4 registry planned; enrollment begins by end of 2026. 05/13/26:- Early U.S. launch gaining traction; 0.2M Q1 2026 net sales; Express Scripts national formulary coverage secured. 08/12/26:- Q2 2026 net product revenue was $0.6M; coverage reached about 50%. ESC presentation will occur August 28-31, 2026. EMA decision is expected in H1 2027.
Verification
Confirm timing and program details against the company announcement or filing.