regulatory
confidence high
sentiment positive
materiality 0.75
Milestone Pharma announces EMA acceptance of MAA for etripamil in PSVT; decision expected Q1 2027
Milestone Pharmaceuticals Inc.
- EMA accepted Marketing Authorization Application for etripamil nasal spray (TACHYMIST) for PSVT; decision expected Q1 2027.
- Phase 3 RAPID trial: 64% conversion to sinus rhythm at 30 min vs 31% placebo (p<0.001); median time 17 min vs 54 min.
- Drug is conditionally approved brand name TACHYMIST in Europe; ~2 million PSVT patients in Europe.
- MAA includes global clinical data that supported U.S. FDA approval of etripamil for PSVT.