Milestone Pharmaceuticals(US:MIST) Globenewswire·2025-06-16 12:00Core Viewpoint - Milestone Pharmaceuticals has submitted a response to the FDA's Complete Response Letter regarding its New Drug Application for CARDAMYST™ (etripamil) nasal spray, aimed at treating acute episodes of paroxysmal supraventricular tachycardia (PSVT) in adults, with a new PDUFA date expected within the year [1][2]. Group 1: Company Overview - Milestone Pharmaceuticals Inc. is a biopharmaceutical company focused on developing innovative cardiovascular solutions to enhance the lives of individuals with complex heart conditions [4]. - The company's lead investigational product, etripamil, is a novel calcium channel blocker nasal spray designed for self-administration, allowing patients to manage symptomatic episodes of PSVT and AFib-RVR without immediate medical supervision [3][4]. Group 2: Product Development - Etripamil is under clinical development for frequent and symptomatic episodes of PSVT and AFib-RVR, with a robust clinical trial program that includes a completed Phase 3 program for PSVT and a Phase 2 trial for AFib-RVR [3]. - If approved, CARDAMYST™ will be the first self-administered therapy for the rapid termination of PSVT episodes, providing patients with greater control over their condition [2][3]. Group 3: Regulatory Interaction - The recent Type A meeting with the FDA was deemed productive, providing necessary guidance for the resubmission of the NDA [2]. - The acceptance of the response and the corresponding PDUFA date will be determined within the next thirty days, with the review expected to take between 2 to 6 months from resubmission [1].