FDA accepts Milestone's CRL response for CARDAMYST; new PDUFA Dec 13, 2025

Milestone Pharmaceuticals Inc.

FDA accepted Milestone's response to CRL for CARDAMYST (etripamil) nasal spray for PSVT; new PDUFA target date Dec 13, 2025.
$75M Royalty Purchase Agreement with RTW extended; approval deadline moved from Sept 30, 2025 to Dec 31, 2025.
CRL response submitted June 13, 2025 after FDA Type A meeting; included additional nitrosamine studies and facility transfer.
FDA raised no concerns regarding clinical section of NDA.
RTW proceeds expected to aid CARDAMYST commercial launch if approved.

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