Milestone Pharmaceuticals Announces FDA Acceptance of the Company’s Response to the CRL for CARDAMYST™ (etripamil) Nasal Spray

Provided By GlobeNewswire

Last update: Jul 11, 2025

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MONTREAL and CHARLOTTE, N.C., July 11, 2025 (GLOBE NEWSWIRE) -- Milestone^® Pharmaceuticals Inc. (Nasdaq: MIST) (Milestone) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Milestone’s response to issues raised in the Complete Response Letter (CRL) for CARDAMYST™ (etripamil) nasal spray, an investigational, novel therapy for the treatment of patients with paroxysmal supraventricular tachycardia (PSVT). The FDA has assigned a new Prescription Drug User Fee Act (PDUFA) target action date of December 13, 2025.