European decision on approval is expected by Q1 2027If approved, etripamil nasal spray is expected to offer patients a safe and effective self-administered treatment option for PSVT outside of the healthcare setting MONTREAL and CHARLOTTE, N.C., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the acceptance of a Marketing Authorization Applic ...

As previously reported, TD Cowen upgraded Milestone Pharmaceuticals (MIST) to Buy from Hold with an $8 price target after Cardamyst nasal spray was approved by the FDA for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia to sinus rhythm in adults. The label is clean with no market-limiting warnings or monitoring requirements, notes the analyst, who also points out that Cardamyst will be available in retail pharmacies in Q1 of 2026 with a wholesale acquisition cost of ...

PresentationI will now turn the conference over to Michael Wood at LifeSci Advisors. Thank you. You may begin.Michael WoodLifesci Advisors, LLC Thank you, operator. Good morning, everyone, and welcome to Milestone's conference call and webinar to discuss the FDA approval of CARDAMYST nasal spray. On a Friday evening, the company issued a press release on the approval. This can be accessed on the News & Events page of the company's corporate website at milestonepharma.com. During today's call, the company w ...

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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 ...

Milestone Pharmaceuticals Inc. (MIST) has received for its first commercial product, CARDAMYST nasal spray, for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia to sinus rhythm in adults.Paroxysmal supraventricular tachycardia, caused by an abnormality in the electrical system of the heart, affects more than two million Americans. People with this condition experience unexpected episodes of rapid heart rate, ranging from 160 to 220 beats per minute or sometimes exceed ...

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 (NASDAQ:MIST) is currently viewed as a promising investment opportunity, with analysts at Jefferies raising the price target from $1 to $2, maintaining a Hold rating [1][2]. Company Overview - Milestone Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing cardiovascular medicines for self-administration by patients with episodic heart conditions [3]. Product Development and Sales Prospects - The price target increase is attributed to the company's confidence in its upcoming PDUFA, with a product launch scheduled for early next year [2]. - The company anticipates that the first quarter of next year will mark the beginning of significant sales, supported by the deployment of 60 representatives targeting up to 15,000 high-volume prescribers [2]. - Milestone is developing Etripamil, a nasal-administered, short-acting calcium channel blocker aimed at treating paroxysmal supraventricular tachycardia (PSVT) [2].

Financial Performance - Milestone Pharmaceuticals reported cash, cash equivalents, and short-term investments of $82.6 million as of September 30, 2025, up from $69.7 million at the end of 2024[6]. - 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 for the same period in 2024[7]. - Total liabilities increased to $67.2 million as of September 30, 2025, compared to $62.4 million at the end of 2024[13]. - The company's accumulated deficit reached $413.2 million as of September 30, 2025, up from $367.5 million at the end of 2024[13]. Research and Development - Research and development expenses for Q3 2025 were $3.9 million, slightly down from $4.0 million in Q3 2024, while total R&D expenses for the nine months ended September 30, 2025, increased to $12.6 million from $10.4 million in the prior year[6]. - The Phase 3 protocol for etripamil in atrial fibrillation with rapid ventricular rate (AFib-RVR) has been finalized, with plans to leverage data from the PSVT NDA for regulatory approval[4]. - Etripamil has shown aligned efficacy and safety across multiple studies, with higher conversion rates for symptomatic PSVT episodes compared to placebo[3]. Commercial Activities - Commercial expenses surged to $4.6 million in Q3 2025, compared to $1.9 million in Q3 2024, reflecting increased preparations for the launch of CARDAMYST[6]. - The company completed a public equity offering that provided net proceeds of approximately $48.7 million, which, along with a $75 million royalty payment upon FDA approval, is expected to fund the launch of CARDAMYST[5]. - The Prescription Drug User Fee Act (PDUFA) target date for CARDAMYST (etripamil) is set for December 13, 2025, with promotional launch plans in place pending FDA approval[1].