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Milestone Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Regulatory and Corporate Update
– NDA for etripamil in PSVT resubmitted in 1Q 2024– Cash resources as of March 31, 2024 expected to fund operations into 2026– Dialogue with FDA to finalize
About this update from Milestone Pharmaceuticals Inc.
[{"type":"text","content":"– NDA for etripamil in PSVT resubmitted in 1Q 2024– Cash resources as of March 31, 2024 expected to fund operations into 2026– Dialogue with FDA to finalize Phase 3 protocol for etripamil in AFib-RVR is progressing MONTREAL and CHARLOTTE, N.C., May 13, 2024 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the first quarter ended March 31, 2024 and provided a regulatory and corporate update. “We’re currently on track for the potential FDA approval of CARDAMYST™ (etripamil) nasal spray in the first half of 2025 to deliver a valuable treatment option to patients suffering from PSVT,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “We remain focused on working with FDA through the review process and preparing for commercialization and launch readiness. We expect that our current cash position, together with a potential future synthetic royalty payment, provides the needed resources to launch CARDAMYST in the U.S. market for patients suffering from PSVT.” First Quarter and Recent Program Updates Etripamil for Patients with paroxysmal supraventricular tachycardia (PSVT) Resubmitted a New Drug Application (NDA) for etripamil for PSVT. The resubmission followed a Type A meeting held with the U.S. Food and Drug Administration (FDA) in February 2024, during which the Company worked to reach alignment with the Agency on resolution of the items raised in the Refusal to File letter. The resubmission package included restructured data sets that captured timing of reported adverse events in the Phase 3 PSVT trial and certain data files reformatted to facilitate the FDA’s analyses. The Company currently expects a standard NDA review period.New clinical data, demonstrating real-world use of etripamil for conversion of PSVT, were presented at The American College of Cardiology Scientific Sessions and published in the Journal of the American College of Cardiology. The NODE-303 Phase 3 study (ClinicalTrials.gov ID NCT04072835) evaluated self-administered etripamil in an outpatient setting for up to multiple episodes of PSVT. The results indicated that symptom-prompted treatment with etripamil converted PSVT (restoring sinus rhythm) was 60.0% by 30 minutes after drug self-administration, and 69.9% by 60 minutes after drug self-administration; these rates ...