Milestone submits CRL response for CARDAMYST (etripamil) PSVT NDA after Type A meeting

Milestone Pharmaceuticals Inc.

Submitted CRL response to FDA on June 16, 2025, following a productive Type A meeting.
FDA will determine acceptance and set PDUFA date within 30 days.
Review timeline expected to be 2 or 6 months depending on classification.
CARDAMYST, if approved, would be the first self-administered therapy for acute PSVT episodes.

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