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Sep 30, 2022
Milestone Pharmaceuticals Q3 2022 Earnings Report
Reported financial results for the third quarter and provided a clinical and corporate update.
Key Takeaways
Milestone Pharmaceuticals reported financial results for the third quarter ended September 30, 2022, and provided a clinical and corporate update. The company is keenly focused on preparations for their planned New Drug Application (NDA), which they expect to submit to the U.S. Food and Drug Administration (FDA) in mid-2023 pending agency feedback.
Phase 3 RAPID trial of etripamil in patients with PSVT achieved primary efficacy endpoint.
Safety and tolerability data from repeat dose administration consistent with prior studies utilizing single-dose administration of etripamil.
Analyses from etripamil Phase 3 PSVT studies featured during Late-Breaking session at AHA Scientific Sessions 2022 demonstrated significant reductions in emergency department utilization for etripamil-treated patients.
Company plans to submit NDA for etripamil in PSVT to the U.S. FDA in mid-2023 pending Agency feedback
Forward Guidance
Milestone Pharmaceuticals plans to submit NDA for etripamil in PSVT to the U.S. FDA in mid-2023 pending Agency feedback.
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