regulatory
confidence high
sentiment neutral
materiality 0.80
Milestone Pharma plans to resubmit NDA for etripamil in 2Q2024 after FDA Type A meeting
Milestone Pharmaceuticals Inc.
- FDA indicated that timing of adverse events had minimal impact on overall etripamil safety profile.
- No additional clinical efficacy or safety trials required before NDA resubmission; standard review expected.
- NDA resubmission for paroxysmal supraventricular tachycardia (PSVT) planned for 2Q2024.
- Cash conservation measures extend operating runway into mid-2025, covering expected PDUFA date.
- Upon FDA approval, Milestone would receive a $75M payment under an existing royalty agreement.