Core Insights - Milestone Pharmaceuticals Inc. will present at the TD Cowen 46th Annual Health Care Conference from March 2-4, 2026 [1] - A live webcast of the presentation will be available on March 3 at 9:10 AM EST, with a replay accessible for approximately 90 days [2] Company Overview - Milestone Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative cardiovascular medicines for individuals with specific heart conditions [3] - The company's lead product, CARDAMYST™ (etripamil) nasal spray, is an FDA-approved treatment for converting acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults [3] - Etripamil is also under development for treating symptomatic episodic attacks associated with atrial fibrillation with rapid ventricular response (AFib-RVR) [3]

Core Insights - Milestone Pharmaceuticals has appointed David Sandoval as General Counsel and Chief Compliance Officer, coinciding with the launch of CARDAMYST™ (etripamil) nasal spray, the first self-administered treatment for acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) in adults [1][3] Company Overview - Milestone Pharmaceuticals Inc. is a biopharmaceutical company focused on developing and commercializing innovative cardiovascular medicines, with CARDAMYST™ as its lead product [16] - CARDAMYST™ is a novel calcium channel blocker nasal spray approved by the FDA for converting acute symptomatic episodes of PSVT to sinus rhythm in adults [5][16] Product Details - CARDAMYST™ is designed as a self-administered rapid response therapy, allowing patients to manage their condition without immediate medical oversight [5] - The product has undergone a robust clinical trial program, including a completed Phase 3 clinical-stage program for PSVT treatment [6] Leadership Appointment - David Sandoval brings over 15 years of experience in legal and compliance functions within the life sciences sector, focusing on late-stage development and regulatory approval [2] - His previous roles include Senior Vice President and General Counsel at MaxCyte, where he oversaw global legal and compliance activities and played a key role in strategic transactions [2][4] Strategic Importance - The appointment of Mr. Sandoval is seen as critical for Milestone as it prepares for the commercialization of CARDAMYST, with expectations of scaling operations and building infrastructure for long-term growth [3]

Core Viewpoint - Milestone Pharmaceuticals (MIST) has been upgraded to a Zacks Rank 1 (Strong Buy), indicating a positive outlook driven by rising earnings estimates, which are crucial for stock price movements [1][4]. Earnings Estimates and Revisions - The Zacks Consensus Estimate for Milestone Pharmaceuticals indicates an expected earnings of -$0.71 per share for the fiscal year ending December 2025, showing no year-over-year change [9]. - Over the past three months, analysts have raised their earnings estimates for Milestone Pharmaceuticals by 41.1% [9]. Zacks Rating System - The Zacks rating system is based solely on changes in a company's earnings picture, making it a reliable tool for investors [2][3]. - The system classifies stocks into five groups, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [8]. - Only the top 5% of Zacks-covered stocks receive a "Strong Buy" rating, indicating superior earnings estimate revisions [10][11]. Market Implications - The upgrade to Zacks Rank 1 for Milestone Pharmaceuticals suggests an improvement in the company's underlying business, likely leading to increased buying pressure and a rise in stock price [6][11]. - The correlation between earnings estimate revisions and near-term stock movements highlights the importance of tracking these revisions for investment decisions [7].

Core Insights - Milestone Pharmaceuticals has launched its first commercial product, CARDAMYST™ (etripamil) nasal spray, for the treatment of paroxysmal supraventricular tachycardia (PSVT) in adults, now available through U.S. retail pharmacies [2][4][8] - The FDA approved CARDAMYST on December 12, 2025, marking the first new treatment for PSVT in over 30 years [6] Product Launch and Support - CARDAMYST will be supported by a patient assistance platform that includes benefits verification, reimbursement support, and copay assistance, with copays capped at $25 for eligible commercially insured patients [3][5] - A national sales force is set to be deployed in mid-February 2026 to promote the product [2][5] Patient Impact and Market Need - Approximately two million people in the U.S. are diagnosed with PSVT, which causes episodes of rapid heartbeats and can significantly impact daily life [7] - The availability of CARDAMYST provides patients with a self-administered treatment option, allowing for on-demand care and greater control over their condition [4][8] Clinical Background - CARDAMYST is a novel calcium channel blocker designed for rapid response therapy, bypassing the need for immediate medical oversight [8] - The product has undergone a robust clinical trial program, including a completed Phase 3 clinical-stage program for PSVT [8]

Company Overview - Milestone Pharmaceuticals Inc. (MIST) was founded in 2003 and is based in both Montreal and Charlotte, employing over 30 individuals across these locations [1] Product Development - The company has developed a nasal spray, indicating its focus on innovative biotech solutions [1] Investment Philosophy - The investment approach emphasizes the importance of compounding, dividend reinvesting, and patient investing through various market conditions to achieve wealth accumulation [1]

Core Viewpoint - Milestone Pharmaceuticals has announced the acceptance of a Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for etripamil nasal spray, aimed at treating paroxysmal supraventricular tachycardia (PSVT) outside of healthcare settings, with a decision expected by Q1 2027 [1][7] Company Overview - Milestone Pharmaceuticals Inc. is a biopharmaceutical company focused on developing and commercializing innovative cardiovascular medicines, with its lead product being CARDAMYST™ (etripamil) nasal spray, which is FDA approved for PSVT treatment in adults [9] Product Details - Etripamil is a novel calcium channel blocker delivered via nasal spray, designed for self-administration by patients, potentially offering a rapid response to PSVT episodes [1][6] - The product is conditionally approved in Europe under the brand name TACHYMIST™ [1][8] Clinical Trial Insights - The MAA submission is supported by data from over 1,800 participants and more than 2,000 PSVT episodes, including results from the Phase 3 RAPID trial, which demonstrated that 64% of participants using etripamil converted to sinus rhythm within 30 minutes compared to 31% on placebo [3][4] - Etripamil users were found to convert symptomatic PSVT to sinus rhythm more than three times faster than those on placebo, with a median conversion time of 17 minutes for etripamil versus 54 minutes for placebo [3] Safety Profile - A consistent safety profile was observed across all subgroups, with the most common adverse events being mild-to-moderate and transient, such as nasal discomfort and congestion [4] - Less than 2% of trial participants discontinued therapy due to adverse events [4] Market Potential - Approximately two million people in Europe are diagnosed with PSVT, indicating a significant market opportunity for etripamil as a self-administered treatment option [2][5]

Core Viewpoint - TD Cowen upgraded Milestone Pharmaceuticals (MIST) to Buy from Hold with a price target of $8 following the FDA approval of Cardamyst nasal spray for treating acute symptomatic episodes of paroxysmal supraventricular tachycardia in adults [1] Group 1: FDA Approval and Product Details - Cardamyst nasal spray received FDA approval for converting acute symptomatic episodes of paroxysmal supraventricular tachycardia to sinus rhythm in adults [1] - The product label is noted to be clean, with no market-limiting warnings or monitoring requirements [1] - Cardamyst is expected to be available in retail pharmacies in Q1 of 2026, with a wholesale acquisition cost of $1,649 [1]

Core Viewpoint - The FDA has approved Milestone's CARDAMYST nasal spray, marking a significant milestone for the company and its product portfolio [2]. Group 1: Company Overview - Milestone's President and CEO, Joe Oliveto, will provide opening remarks and discuss the product label details during the conference call [4]. - Dr. David Bharucha, the Chief Medical Officer, will address the medical need from a clinician's perspective [4]. - Lorenz Muller, the Chief Commercial Officer, will outline the launch plans for CARDAMYST nasal spray [4].

Group 1 - The article does not contain any relevant content regarding company or industry insights [1]

Summary of Milestone Pharmaceuticals' CARDAMYST FDA Approval Call Company and Product Overview - **Company**: Milestone Pharmaceuticals (NasdaqGS: MIST) - **Product**: CARDAMYST nasal spray - **Indication**: Treatment of Paroxysmal Supraventricular Tachycardia (PSVT) - **FDA Approval Date**: December 15, 2025 - **Market Size**: Over 2 million Americans suffer from PSVT, costing the healthcare system at least $5 billion annually due to emergency visits and hospitalizations [4][22] Key Points and Arguments FDA Approval and Product Significance - CARDAMYST is the first new therapeutic option for PSVT in over 30 years, providing rapid-acting treatment outside healthcare settings [4][11] - The product label received from the FDA met or exceeded expectations, with no major surprises in clinical efficacy and safety data [5][7] - Clinical trials demonstrated that CARDAMYST converts twice as many patients by 30 minutes and three times faster than existing treatments [6][19] Clinical Efficacy and Safety - The primary efficacy endpoint showed a significant p-value at 30 minutes, indicating rapid conversion [5] - Safety profile: Only 0.4% of patients experienced hypotension, and 0.1% experienced syncope, with no significant adverse events reported [7][8] - The product is designed to empower patients to manage their PSVT episodes, reducing reliance on emergency departments [11][19] Commercialization Strategy - The vision for commercial success includes making CARDAMYST easy to use for patients and prescribers, and pricing it to minimize payer restrictions [9][10] - The initial sales force will consist of 60 representatives targeting 10,000 healthcare providers managing 500,000 PSVT patients [24][25] - The wholesale acquisition cost (WAC) is set at $1,649 per prescription, with expected net revenues between $500 and $1,000 [30][57] Market Access and Payer Strategy - Payers are currently not managing PSVT actively, and Milestone aims to secure tier two or three formulary positions with rational pricing [27][29] - The company plans to offer reimbursement support and a copay mitigation program for commercially insured patients [29][30] - The split of patients with PSVT is approximately 45% commercially insured, 45% Medicare, and 10% Medicaid [40] Physician Engagement and Adoption - Physicians have expressed a low barrier to prescribing CARDAMYST due to familiarity with calcium channel blockers [23][26] - The product is expected to be used as an add-on therapy for patients on chronic prophylaxis or as a bridge therapy for those awaiting ablation [26][80] - Early adopters among electrophysiologists are anticipated to drive initial prescriptions, with broader adoption expected over time [61][63] Additional Important Insights - The approval marks a significant transition for Milestone Pharmaceuticals into a commercial organization [34] - The company emphasizes the importance of patient-centric design in the development of CARDAMYST, aiming to alleviate the anxiety associated with PSVT episodes [11][19] - The launch year goals focus on driving provider awareness, trial, and usage, while establishing broad access and affordability [31][32] This summary encapsulates the critical aspects of Milestone Pharmaceuticals' conference call regarding the FDA approval of CARDAMYST, highlighting its significance in the treatment of PSVT, commercialization strategies, and market dynamics.