milestone pharmaceuticals pipeline

MONTREAL, Canada and CHARLOTTE, NC, USA I March 23, 2020 I Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced topline results from its Phase 3, multicenter, randomized, double-blind, placebo-controlled NODE-301 trial of its investigational new drug, etripamil … This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Etripamil is currently being tested in Phase 3 trials for PSVT. The NODE-301 trial, which enrolled a total of 431 patients across 65 sites in the U.S. and Canada, is an event-driven Phase 3 efficacy trial of etripamil for terminating supraventricular tachycardia (SVT) episodes in the at-home setting. (PSVT). Milestone Pharmaceuticals Milestone Pharmaceuticals operates in Canada and the United States. ", "PSVT places a significant burden on patients and the healthcare system, and a fast-acting therapy to resolve its symptoms when and where episodes occur would have a material impact on both," said Bruce Stambler, MD, FHRS, Piedmont Heart Institute, Atlanta, GA. "NODE-301 is a first-of-its-kind study, and as such encountered  a number of challenges relative to studying SVT episodes outside of a controlled electrophysiology laboratory environment. Paroxysmal supraventricular tachycardia (PSVT), Atrial Fibrillation with Rapid Ventricular Rate (AF-RVR), Developing Novel Therapies for Cardiovascular Conditions, Milestone Pharmaceuticals, Inc. News Releases, Milestone Pharmaceuticals to Present at the Jefferies Virtual London Healthcare Conference, Milestone Pharmaceuticals Announces Pricing of a Public Offering of $45 Million of Common Shares and Pre-Funded Warrants, Milestone Pharmaceuticals Announces Proposed Public Offering of Common Shares and Pre-Funded Warrants. beat of the way. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, the risks inherent in biopharmaceutical product development and clinical trials, including the lengthy and uncertain regulatory approval process, uncertainties related to the timing of initiation, enrollment and completion of clinical trials, and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others. The study is designed for a population of those PSVT patients who historically experience 20 minutes or longer SVT episodes or episodes requiring termination in the emergency department. We’re developing a nasal spray that fits in your pocket, so you can live confidently and fully. Etripamil is a proprietary, small molecule, new chemical entity that was conceived, discovered, and optimized by Milestone. The Company expects to request a meeting with regulators to discuss the NODE-301 results and its ongoing studies. (AF-RVR). MONTREAL and CHARLOTTE, N.C., March 6, 2020 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today reported financial results for the fourth quarter and year ended December 31, 2019 and provided a clinical and corporate update. To that end, we partner with groups and organizations who share our dedication to supporting and educating people with episodic cardiovascular conditions. ", About Paroxysmal Supraventricular Tachycardia. (PSVT), Atrial Fibrillation OUR PIPELINE A Pocket-Sized Nasal Spray to the Rescue We’ve designed and are developing the investigational drug, etripamil: a new, potent, and fast-acting calcium channel blocker in the form of a nasal spray to stop PSVT or other episodic cardiovascular conditions whenever and wherever they occur. For more information, visit www.milestonepharma.com and follow the Company on Twitter at @MilestonePharma. Mid-stage and early portfolios of these companies are analyzed in detail in the report. There were no significant differences in incidences of severe adverse events or adverse events of interest, such as atrioventricular nodal blocks or blood pressure-related symptoms, across the etripamil and placebo groups. That said, outcomes after 100 minutes, which were affected by a very small number of placebo patients remaining in the study at that time, suggest that the design and analysis plan used in NODE-301 negatively impacted the study's outcome,"  said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. Secondary study endpoints include relief of symptoms commonly associated with an episode of SVT such as heart palpitations, chest pain, anxiety, shortness of breath, dizziness, or fainting, and rating of treatment satisfaction questionnaire for medication (TSQM). Please select which country’s site you’d like to visit. All Rights Reserved. The Company is actively monitoring the potential impact of the COVID-19 pandemic on its ongoing trials and will provide updates on any delayed timelines or cost impacts in the future. MONTREAL and CHARLOTTE, N.C. , May 14, 2020 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today reported financial results for the first quarter ended March 31, 2020 Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Milestone Pharmaceuticals operates in Canada and the United States. "Results from NODE-301, if favorable, have the potential to serve as the sole efficacy registration trial required for an NDA submission with the United States (U.S.) Food and Drug Administration (FDA), bringing us one step closer to providing paroxysmal supraventricular tachycardia (PSVT) patients with a much-needed novel therapeutic option. At Milestone, everything we do is with the patient in mind. – Topline data from Phase 3 NODE-301 trial of etripamil in patients with PSVT expected this month –. Except as required by law, Milestone assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. "Our team is keenly focused on delivering the near-term topline readout of the pivotal Phase 3 efficacy and safety trial, NODE-301," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. Milestone aims to provide that sense of security. The study demonstrated statistically significant improvements in favor of etripamil over placebo in the important secondary endpoint of patient reported treatment satisfaction, as measured by a treatment satisfaction questionnaire for medication (TSQM-9), including global satisfaction (p=0.0069) and effectiveness scores (p=0.0015), with questions addressing the relief of symptoms commonly associated with an episode of SVT, such as rapid pulse, heart palpitations, anxiety, shortness of breath and dizziness. //


No Comments Yet.

leave a comment