Business
Milestone Pharmaceuticals Provides Positive Regulatory Updates for Etripamil Pivotal Program in PSVT and Reports Second Quarter 2019 Financial Results
- FDA agrees to allow initiation of NODE-303 open-label safety study without test dose and in population consistent with ongoing studies - - NODE-301 trial
About this update from Milestone Pharmaceuticals Inc.
[{"type":"text","content":"- FDA agrees to allow initiation of NODE-303 open-label safety study without test dose and in population consistent with ongoing studies -\n- NODE-301 trial upsized from 100 to 150 adjudicated PSVT events to satisfy EMA requirements; Company remains on track for topline readout in 1H20 -\n- Company to host mid-year business update conference call today at 8:00 a.m. ET -\n MONTREAL and CHARLOTTE, N.C., Aug. 13, 2019 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a Phase 3 clinical-stage biopharmaceutical company dedicated to developing and commercializing etripamil for the treatment of cardiovascular indications, today announced positive regulatory updates based on its interaction with the U.S. Food and Drug Administration (FDA) that advance its pivotal program of etripamil, the Company's novel, potent and short-acting calcium channel blocker, in patients with paroxysmal supraventricular tachycardia (PSVT). The Company also reported financial results for the second quarter ended June 30, 2019.\n\"We are very encouraged by our most recent interaction with the FDA and remain well positioned for continued execution of our etripamil pivotal program in PSVT,\" said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. \"Following this interaction, we now look forward to beginning enrollment in our NODE-303 open-label global safety study before the end of the year. Execution of our pivotal Phase 3 NODE-301 trial is also tracking ahead of our initial projections, and upsizing of the trial will enable us to satisfy a European Medicines Agency (EMA) regulatory request, increase the study's power and potentially strengthen valuable sub-population analyses and pharmacoeconomic assessments, all while remaining on schedule to report topline data in the first half of 2020. Etripamil has the potential to serve as the first-ever self-administered therapy for the rapid termination of episodes of PSVT wherever and whenever they occur, and our continued progress takes us steps closer to realizing this potential to help patients living with PSVT.\"\nRegulatory Updates\nFollowing interaction with the FDA, the Company announced several regulatory updates to its etripamil pivotal program in patients with PSVT:\nInitiation of NODE-303 open-label safety study. Based on a review of etripamil safety data to dat...