New appointment strengthens executive leadership commensurate with launch of CARDAMYST™ (etripamil) nasal sprayMONTREAL and CHARLOTTE, N.C., Feb. 10, 2026 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today announced the appointment of David Sandoval as General Counsel and Chief Compliance Officer. Mr. Sandoval’s appointment comes as Milestone launches CARDAMYST™ (etripamil) nasal spray, the first and only approved self-administered treatment for the conversion of acute symptomatic episo ...

Milestone Pharmaceuticals (MIST) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #1 (Strong Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by ...

CARDAMYST is now conveniently available to patients through retail pharmaciesNational sales force hired with promotional launch in mid-FebruaryExpected $25 copay cap for eligible commercially insured patientsLaunch supported by comprehensive patient assistance program offering benefits verification and reimbursement support MONTREAL and CHARLOTTE, N.C., Jan. 26, 2026 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today announced that CARDAMYST™ (etripamil) nasal spray, its first commerc ...

Milestone Pharmaceuticals Inc. ( MIST ) was founded in 2003 and is based, jointly, in both Montreal and Charlotte, with its 30+ employees split between both locations. It is an early-stage biotech company that has developed a nasal spray based onI have been investing in the stock market since I was 17 years old, and over the 25+ years since I have learned the joy of compounding, the value of dividend reinvesting, and the principle that patient investing through good times and bad brings the greatest rewards ...

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.

FDA Approval Investor Call December 15, 2025 Forward Looking Statements The Presentation contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Words such as ''aim,'' ''anticipate,'' ''assume,'' ''believe,'' ''contemplate,'' ''continue,'' ''could,'' ''design,'' ''due,'' ''estimate,'' ''expect,'' ''goal,'' ''intend,'' ''may,'' ''objective,'' ''plan,'' ''predict,'' ''positioned,'' ''potential,'' ''project,'' ''s ...