MIST Milestone Pharma

etripamil · NCT06716021 registry update

countries: {'total_sites': 11, 'us_sites': 4} → {'total_sites': 15, 'us_sites': 4}

etripamil · NCT06716021 registry update

countries: {'total_sites': 3, 'us_sites': 2} → {'total_sites': 11, 'us_sites': 4}

Milestone Pharmaceuticals to present PSVT data at ESC Congress Aug 28-31

The company announced that an analysis of PSVT patient burden and quality-of-life impact will be presented at the European Society of Cardiology Congress (Aug 28-31, 2026). This is a scheduled scientific conference presentation, not a regulatory decision or new clinical readout.

Milestone initiates Phase 3 AFib-RVR trial for etripamil

Milestone has initiated a Phase 3 registrational program to evaluate self-administered etripamil for atrial fibrillation with rapid ventricular rate (AFib-RVR). The company is onboarding clinical sites and expects to enroll the first patient in H2 2026, following the sNDA regulatory pathway.

Milestone Pharmaceuticals receives FDA approval for CARDAMYST (etripamil) nasal spray

FDA approved CARDAMYST (etripamil) nasal spray for the conversion of acute symptomatic PSVT episodes to sinus rhythm in adults. The product is now indicated for self-administration by patients, providing a new non-invasive treatment option with demonstrated efficacy in the RAPID trial. The approval enables Milestone to begin commercial launch activities with a 60-rep sales force targeting ~10,000 prescribers.

MIST: PDUFA target date December 13, 2025 for CARDAMYST (etripamil) nasal spray in PSVT

The NDA for etripamil nasal spray is under FDA review with a PDUFA target action date of December 13, 2025. Milestone has completed pre-launch preparations and secured financing to enable rapid commercialization if approved.