Milestone Pharmaceuticals(MIST)

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Milestone® Pharmaceuticals to Present at the TD Cowen 45th Annual Health Care Conference
GlobeNewswire· 2025-02-27 13:00
Core Insights - Milestone Pharmaceuticals Inc. will present at the TD Cowen 45th Annual Health Care Conference from March 3-5, 2025 [1] - A live webcast of the presentation will be available on March 4 at 9:10 AM EST, with a replay option for 90 days [2] - Milestone Pharmaceuticals focuses on developing innovative cardiovascular solutions, with its lead product being etripamil, a nasal spray for self-administration in treating symptomatic episodic attacks associated with PSVT and AFib-RVR [3]
Milestone® Pharmaceuticals Notice of Allowance on New U.S. Patent for Etripamil
GlobeNewswire News Room· 2025-02-19 13:00
Core Viewpoint - Milestone Pharmaceuticals has received a Notice of Allowance for a new Method of Use patent for its lead investigational product, etripamil nasal spray (proposed trade name CARDAMYST), aimed at managing paroxysmal supraventricular tachycardia (PSVT) [1][2] Group 1: Patent and Intellectual Property - The patent covers the repeat dose regimen used in the RAPID Phase 3 study for CARDAMYST, which is part of the New Drug Application (NDA) currently under FDA review [2][4] - The Notice of Allowance potentially extends intellectual property protection for CARDAMYST in the U.S. until July 2042, providing an additional 6 years of protection [2][3] Group 2: Product Development and Commercialization - 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 oversight [5][6] - The NDA for CARDAMYST is under FDA review with a Prescription Drug User Fee Act (PDUFA) target date of March 27, 2025, and commercial preparations are advancing for an anticipated launch in mid-2025 [4][6] Group 3: Company Overview - Milestone Pharmaceuticals focuses on developing innovative cardiovascular solutions to improve the lives of patients with complex heart conditions, emphasizing unmet patient needs and self-management [6]
Milestone Pharmaceuticals to Host Commercial Launch Plan Investor Event in New York on February 25, 2025
GlobeNewswire· 2025-02-11 13:00
Core Viewpoint - Milestone Pharmaceuticals is preparing for the commercial launch of its lead investigational product, etripamil nasal spray (proposed trade name CARDAMYST™), aimed at managing paroxysmal supraventricular tachycardia (PSVT) with a launch expected in mid-2025 [2][4]. Group 1: Company Overview - Milestone Pharmaceuticals Inc. is a biopharmaceutical company focused on developing innovative cardiovascular solutions to improve the lives of patients with complex heart conditions [5]. - The company emphasizes understanding unmet patient needs and enhancing the patient experience through new treatment approaches that allow for self-management [5]. Group 2: Product Details - Etripamil is a novel calcium channel blocker nasal spray designed for self-administration, targeting symptomatic episodes of PSVT and atrial fibrillation with rapid ventricular rate (AFib-RVR) [4]. - The product is currently under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target date of March 27, 2025 [2]. - Etripamil aims to provide healthcare providers with a new treatment option for on-demand care and patient self-management, potentially enhancing patients' control over their condition [4]. Group 3: Upcoming Event - Milestone Pharmaceuticals will host an investor event on February 25, 2025, in New York, featuring presentations from the CEO and Chief Commercial Officer, detailing the commercial strategy for etripamil [1][2]. - A live question and answer session will follow the formal presentation, allowing for direct engagement with investors [3].
Milestone Pharmaceuticals Provides 2025 Corporate Outlook and Will Host Investor Event on February 25 in NYC
GlobeNewswire News Room· 2025-01-28 13:00
Core Insights - Milestone Pharmaceuticals is preparing for a transformative year in 2025 with the potential FDA approval of CARDAMYST™ (etripamil) nasal spray for Paroxysmal Supraventricular Tachycardia (PSVT) [3][8] - The company is building commercial capabilities for a targeted launch of CARDAMYST in mid-2025, pending FDA approval [8] - A Phase 3 study for etripamil in patients with atrial fibrillation with rapid ventricular rate (AFib-RVR) is set to begin in the first half of 2025 [6] Company Overview - Milestone Pharmaceuticals Inc. focuses on developing and commercializing innovative cardiovascular medicines to improve patient care [10] - Etripamil is the lead investigational product, designed as a self-administered nasal spray for managing symptomatic episodes of PSVT and AFib-RVR [7][10] Regulatory and Clinical Developments - The FDA Prescription Drug User Fee Act (PDUFA) target date for CARDAMYST is March 27, 2025, with no advisory committee planned [8] - The company has completed a Phase 3 clinical program for PSVT and a Phase 2 trial for AFib-RVR, indicating a robust clinical trial background [9] Commercial Strategy - Milestone is enhancing its commercial strategy with the hiring of key personnel, including a new VP of Sales, to prepare for the launch of CARDAMYST [8] - An investor event is scheduled for February 25, 2025, to provide updates on the commercial strategy and product launch [5][8] Upcoming Events - Assuming FDA approval, Milestone will have its first branded product presence at major medical conferences in 2025, including the American College of Cardiology annual meeting and the Heart Rhythm Society Annual Meeting [8]
After Golden Cross, Milestone Pharmaceuticals (MIST)'s Technical Outlook is Bright
ZACKS· 2024-11-19 15:56
Core Viewpoint - Milestone Pharmaceuticals Inc. (MIST) is showing potential for bullish momentum following a technical indicator known as a "golden cross" which occurred when its 50-day simple moving average surpassed its 200-day moving average [1][2] Technical Analysis - The golden cross is characterized by three stages: a downtrend that bottoms out, a crossover of the shorter moving average above the longer one, and continued upward momentum [1] - MIST has experienced a price increase of 15.7% over the last four weeks, indicating a possible breakout [2] - The current Zacks Rank for MIST is 3 (Hold), suggesting a neutral outlook [2] Earnings Outlook - There has been a positive shift in earnings estimates for MIST, with no estimates decreasing in the past two months and two revisions higher [2] - The Zacks Consensus Estimate for earnings has also increased, reinforcing the bullish sentiment around MIST [2]
Milestone Pharmaceuticals(MIST) - 2024 Q3 - Quarterly Results
2024-11-12 14:12
Exhibit 99.1 Milestone Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides Regulatory and Corporate Update NDA for CARDAMYST™ in PSVT under review by FDA; PDUFA March 27, 2025 MONTREAL and CHARLOTTE, N.C., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the third quarter ended September 30, 2024 and provided a corporate update. "Our primary focus at Milestone is preparing for potential FDA approval of CARDAMYST (etrip ...
Milestone Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides Regulatory and Corporate Update
GlobeNewswire News Room· 2024-11-12 14:03
MONTREAL and CHARLOTTE, N.C., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the third quarter ended September 30, 2024 and provided a corporate update. “Our primary focus at Milestone is preparing for potential FDA approval of CARDAMYST (etripamil) nasal spray for the management of PSVT,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “We believe that CARDAMYST has the potential to improve how ...
Milestone Pharmaceuticals(MIST) - 2024 Q3 - Quarterly Report
2024-11-12 12:02
Table of Contents Title of each class Trading Symbol(s) Name of each exchange on which registered Common Shares MIST The Nasdaq Stock Market LLC UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commissi ...
Milestone Partner Ji Xing Pharmaceuticals Ltd Announces Positive Topline Results from the Phase 3 Study of Etripamil in PSVT in China
GlobeNewswire News Room· 2024-09-06 11:00
MONTREAL and CHARLOTTE, N.C., Sept. 06, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced its licensing partner, Ji Xing Pharmaceuticals Ltd, released positive topline results from a multi-center, randomized, double-blind, placebo-controlled trial in China evaluating the efficacy and safety of etripamil nasal spray in paroxysmal supraventricular tachycar ...
Milestone Pharmaceuticals Appoints Industry Veteran Joseph Papa to its Board of Directors
GlobeNewswire News Room· 2024-09-04 12:00
MONTREAL and CHARLOTTE, N.C., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the appointment of Joseph Papa to its Board of Directors ("Board"), effective September 3, 2024. Mr. Papa is a renowned pharmaceutical and healthcare leader, with more than 35 years of experience navigating companies through periods of rapid growth, transformation, ...