regulatory
confidence high
sentiment positive
materiality 0.75
Milestone Pharma gets FDA NDA acceptance for CARDAMYST (etripamil) nasal spray for PSVT
Milestone Pharmaceuticals Inc.
- FDA accepted NDA on May 26, 2024 for CARDAMYST (etripamil) nasal spray for paroxysmal supraventricular tachycardia (PSVT).
- PDUFA target date set at 10 months from acceptance (approx. March 2025).
- CEO Joseph Oliveto cites progress toward a new self-administered treatment option for PSVT patients.
- CARDAMYST clinical program represents the largest data package ever studied for acute self-management of PSVT.
- Brand name CARDAMYST is conditionally approved by FDA; commercial preparations continue for potential launch.