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 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]

Core Insights - Milestone Pharmaceuticals has received FDA approval for CARDAMYST™ (etripamil) nasal spray, marking the first new treatment for paroxysmal supraventricular tachycardia (PSVT) in over 30 years, providing a self-administered option for over two million Americans with this condition [1][4][12] Company Overview - Milestone Pharmaceuticals is a biopharmaceutical company focused on developing innovative cardiovascular medicines, with CARDAMYST being its lead product aimed at treating PSVT [27] Product Details - CARDAMYST is a rapid-acting calcium channel blocker designed for the conversion of acute symptomatic episodes of PSVT to sinus rhythm in adults, allowing patients to manage episodes independently [3][14] - The product is expected to be available in retail pharmacies in the first quarter of 2026 [1] Clinical Data - The FDA approval is supported by a clinical trial program involving over 1,800 participants and more than 2,000 PSVT episodes, demonstrating that CARDAMYST users were twice as likely to convert to sinus rhythm compared to placebo [6][7] - In the Phase 3 RAPID trial, 64% of participants using CARDAMYST converted to sinus rhythm within 30 minutes, compared to 31% for placebo, with a median conversion time of 17 minutes for CARDAMYST versus 54 minutes for placebo [6][7] Market Potential - The approval of CARDAMYST opens the door for further development of etripamil for atrial fibrillation with rapid ventricular rate (AFib-RVR) under a supplemental New Drug Application (sNDA) pathway, targeting an estimated market of three to four million patients by 2030 [4][10][13] Financial Position - As of September 30, 2025, Milestone had cash and equivalents of $82.6 million, positioning the company well for the launch and commercialization of CARDAMYST [22] - The company has entered into a Royalty Purchase Agreement to secure additional funding contingent upon the FDA approval of etripamil [22][23]

Core Insights - Milestone Pharmaceuticals is preparing for the potential launch of CARDAMYST (etripamil) nasal spray for treating symptomatic paroxysmal supraventricular tachycardia (PSVT) with a PDUFA target date set for December 13, 2025 [1][6] - The company has strengthened its financial position through a successful equity offering and an amended Royalty Purchase Agreement, providing resources for a successful launch [2][5] - Etripamil is also being developed for atrial fibrillation with rapid ventricular rate (AFib-RVR), with plans for a pivotal Phase 3 program following positive Phase 2 trial results [4][9] Financial Overview - As of September 30, 2025, Milestone reported cash and cash equivalents of $82.6 million, an increase from $69.7 million at the end of 2024 [12] - The company reported a net loss of $11.9 million for the third quarter of 2025, compared to a net loss of $9.4 million in the same period of 2024 [12][18] - Research and development expenses for the third quarter of 2025 were $3.9 million, slightly down from $4.0 million in the prior year [12][18] Clinical Development - Etripamil has shown promising efficacy and safety in clinical trials, with data from over 600 patients indicating higher conversion rates for symptomatic PSVT compared to placebo [6] - The company plans to leverage data from the PSVT NDA for the supplemental NDA regulatory approval pathway for AFib-RVR [4][6] - Recent presentations at the American Heart Association (AHA) Scientific Sessions highlighted the potential of etripamil as a rapid, self-administered treatment option [6][9]