Milestone Pharma Awaits FDA Decision on CARDAMYST, Stock Under Scrutiny
FDA Decision on CARDAMYST: Milestone Pharmaceuticals is awaiting a pivotal FDA decision on its lead drug candidate, CARDAMYST nasal spray, for treating paroxysmal supraventricular tachycardia (PSVT), with a target action date set for December 13, 2025.
Clinical Trial Support: The NDA submission for CARDAMYST is backed by results from the Phase 3 NODE clinical program, demonstrating efficacy and safety across over 600 patients, with Etripamil showing higher conversion rates than placebo.
Financial Position and Milestone Payment: Milestone reported $82.6 million in cash as of September 30, 2025, bolstered by a recent equity offering, and anticipates a $75 million milestone payment upon FDA approval, aiding in a swift commercial launch.
Market Impact and Stock Performance: Approval of CARDAMYST could be transformative for Milestone, marking the first new pharmacological option for PSVT in decades, while the company's stock has fluctuated between $0.62 and $2.77 over the past year, closing at $2.64 recently.
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CARDAMYST Nasal Spray Now Available at Retail Pharmacies
- Product Launch: Milestone Pharmaceuticals announces that its first commercial product, CARDAMYST™ (etripamil) nasal spray, is now available at U.S. retail pharmacies, marking a significant advancement in the cardiovascular drug market.
- Sales Force Deployment: The company plans to deploy a national sales force in mid-February 2026 to support product promotion and market penetration, which is expected to significantly enhance market coverage and sales potential.
- Patient Assistance Program: CARDAMYST will be supported by a comprehensive patient assistance platform offering benefits verification and reimbursement support, with a projected $25 copay cap for eligible commercially insured patients, thereby reducing financial burdens on patients.
- FDA Approval Milestone: CARDAMYST received FDA approval on December 12, 2025, becoming the first drug approved for treating paroxysmal supraventricular tachycardia (PSVT) in over 30 years, addressing a critical gap in effective treatment options.
Milestone Pharmaceuticals (MIST) Receives EMA Review for Etripamil Nasal Spray
- Regulatory Progress: Milestone Pharmaceuticals' Marketing Authorization Application for Etripamil nasal spray has been accepted for review by the European Medicines Agency, with a decision expected in Q1 2027, potentially offering the first self-administered therapy for PSVT patients in Europe.
- Clinical Data Support: The application is backed by data from over 1,800 participants and more than 2,000 PSVT episodes, demonstrating that 64% of patients using Etripamil converted to sinus rhythm within 30 minutes, compared to only 31% in the placebo group, significantly enhancing treatment options and quality of life for patients.
- Significant Market Potential: As a fast-acting calcium channel blocker, Etripamil aims to provide patients with a reliable option to convert PSVT episodes outside of healthcare settings, which is expected to reduce the need for emergency visits and invasive ablation procedures, thereby alleviating the burden on healthcare systems.
- U.S. Market Performance: Etripamil was approved in the U.S. in December 2025 under the brand name CARDAMYST, with availability in retail pharmacies anticipated this quarter, further strengthening the company's market position in cardiac care.
Aptar Launches CARDAMYST Nasal Spray to Address Needs of 2 Million PSVT Patients
- New Drug Launch: Aptar's Bidose Liquid Nasal Spray System successfully delivers the FDA-approved CARDAMYST nasal spray, aimed at treating paroxysmal supraventricular tachycardia (PSVT), which leads to 40,000 to 120,000 hospitalizations annually, marking the company's expansion into cardiovascular drug delivery.
- Market Demand: With approximately 2 million people diagnosed with PSVT in the U.S., Aptar's launch of CARDAMYST addresses this significant market need, expected to substantially enhance the company's share in the nasal drug delivery market.
- Collaborative Innovation: Aptar's close collaboration with Milestone Pharmaceuticals has resulted in a patient-friendly dual-container system that ensures reliable drug access at critical moments, further solidifying Aptar's leadership in drug delivery technology.
- Strategic Implications: The launch of CARDAMYST not only showcases Aptar's innovative capabilities in drug delivery solutions but also lays the groundwork for future expansions into other therapeutic areas, aligning with the company's long-term growth strategy.
Aptar Launches CARDAMYST Nasal Spray for PSVT Treatment
- New Drug Approval: Aptar's CARDAMYST nasal spray has received FDA approval for converting acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm, addressing the urgent needs of approximately 2 million PSVT patients in the U.S.
- Significant Market Potential: With up to 525,000 emergency department visits annually due to PSVT, the introduction of CARDAMYST is expected to significantly alleviate patient healthcare burdens and enhance quality of life.
- Innovative Delivery System: CARDAMYST features a dual Bidose delivery system that is convenient for patients to carry and use, ensuring reliable drug access at the moment of need, thus improving medication accessibility and usability.
- Strategic Partnership: The close collaboration between Aptar and Milestone Pharmaceuticals highlights Aptar's capability in developing complex treatment solutions, with plans to further expand nasal drug delivery solutions into additional therapeutic areas in the future.
MIST Achieves Landmark Approval: FDA Greenlights First Self-Administered Nasal Spray for PSVT
FDA Approval: Milestone Pharmaceuticals Inc. has received FDA approval for CARDAMYST nasal spray, the first treatment for paroxysmal supraventricular tachycardia (PSVT) in over 30 years, allowing patients to self-administer the medication outside of healthcare settings.
Condition Overview: PSVT affects over two million Americans, causing sudden episodes of rapid heart rate and associated symptoms like palpitations and shortness of breath, particularly among young individuals during vigorous activities.
Product Details: CARDAMYST is a rapid-acting calcium channel blocker designed to treat acute episodes of PSVT, expected to be available in retail pharmacies by the first quarter of 2026.
Stock Performance: Following the announcement, Milestone Pharmaceuticals' stock experienced fluctuations, trading at $2.41 after reaching a 52-week high of $3.06.
FDA Grants Approval for Milestone Pharma's CARDAMYST, the First Self-Administered Therapy for PSVT
FDA Approval: Milestone Pharmaceuticals Inc. received FDA approval for CARDAMYST (etripamil) nasal spray, a treatment for acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) in adults.
Access to Treatment: The approval allows over two million Americans with PSVT to access a rapid-acting, self-administered treatment option outside of healthcare settings, enhancing their ability to manage episodes.
Product Availability: CARDAMYST is expected to be available in retail pharmacies starting in the first quarter of 2026.
Stock Performance: Following the announcement, MIST's stock closed at $2.41, a decline of 18.31%, but saw a slight recovery in after-hours trading to $2.46.
CARDAMYST Nasal Spray Now Available at Retail Pharmacies
- Product Launch: Milestone Pharmaceuticals announces that its first commercial product, CARDAMYST™ (etripamil) nasal spray, is now available at U.S. retail pharmacies, marking a significant advancement in the cardiovascular drug market.
- Sales Force Deployment: The company plans to deploy a national sales force in mid-February 2026 to support product promotion and market penetration, which is expected to significantly enhance market coverage and sales potential.
- Patient Assistance Program: CARDAMYST will be supported by a comprehensive patient assistance platform offering benefits verification and reimbursement support, with a projected $25 copay cap for eligible commercially insured patients, thereby reducing financial burdens on patients.
- FDA Approval Milestone: CARDAMYST received FDA approval on December 12, 2025, becoming the first drug approved for treating paroxysmal supraventricular tachycardia (PSVT) in over 30 years, addressing a critical gap in effective treatment options.
Milestone Pharmaceuticals (MIST) Receives EMA Review for Etripamil Nasal Spray
- Regulatory Progress: Milestone Pharmaceuticals' Marketing Authorization Application for Etripamil nasal spray has been accepted for review by the European Medicines Agency, with a decision expected in Q1 2027, potentially offering the first self-administered therapy for PSVT patients in Europe.
- Clinical Data Support: The application is backed by data from over 1,800 participants and more than 2,000 PSVT episodes, demonstrating that 64% of patients using Etripamil converted to sinus rhythm within 30 minutes, compared to only 31% in the placebo group, significantly enhancing treatment options and quality of life for patients.
- Significant Market Potential: As a fast-acting calcium channel blocker, Etripamil aims to provide patients with a reliable option to convert PSVT episodes outside of healthcare settings, which is expected to reduce the need for emergency visits and invasive ablation procedures, thereby alleviating the burden on healthcare systems.
- U.S. Market Performance: Etripamil was approved in the U.S. in December 2025 under the brand name CARDAMYST, with availability in retail pharmacies anticipated this quarter, further strengthening the company's market position in cardiac care.
Aptar Launches CARDAMYST Nasal Spray to Address Needs of 2 Million PSVT Patients
- New Drug Launch: Aptar's Bidose Liquid Nasal Spray System successfully delivers the FDA-approved CARDAMYST nasal spray, aimed at treating paroxysmal supraventricular tachycardia (PSVT), which leads to 40,000 to 120,000 hospitalizations annually, marking the company's expansion into cardiovascular drug delivery.
- Market Demand: With approximately 2 million people diagnosed with PSVT in the U.S., Aptar's launch of CARDAMYST addresses this significant market need, expected to substantially enhance the company's share in the nasal drug delivery market.
- Collaborative Innovation: Aptar's close collaboration with Milestone Pharmaceuticals has resulted in a patient-friendly dual-container system that ensures reliable drug access at critical moments, further solidifying Aptar's leadership in drug delivery technology.
- Strategic Implications: The launch of CARDAMYST not only showcases Aptar's innovative capabilities in drug delivery solutions but also lays the groundwork for future expansions into other therapeutic areas, aligning with the company's long-term growth strategy.
Aptar Launches CARDAMYST Nasal Spray for PSVT Treatment
- New Drug Approval: Aptar's CARDAMYST nasal spray has received FDA approval for converting acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm, addressing the urgent needs of approximately 2 million PSVT patients in the U.S.
- Significant Market Potential: With up to 525,000 emergency department visits annually due to PSVT, the introduction of CARDAMYST is expected to significantly alleviate patient healthcare burdens and enhance quality of life.
- Innovative Delivery System: CARDAMYST features a dual Bidose delivery system that is convenient for patients to carry and use, ensuring reliable drug access at the moment of need, thus improving medication accessibility and usability.
- Strategic Partnership: The close collaboration between Aptar and Milestone Pharmaceuticals highlights Aptar's capability in developing complex treatment solutions, with plans to further expand nasal drug delivery solutions into additional therapeutic areas in the future.
MIST Achieves Landmark Approval: FDA Greenlights First Self-Administered Nasal Spray for PSVT
FDA Approval: Milestone Pharmaceuticals Inc. has received FDA approval for CARDAMYST nasal spray, the first treatment for paroxysmal supraventricular tachycardia (PSVT) in over 30 years, allowing patients to self-administer the medication outside of healthcare settings.
Condition Overview: PSVT affects over two million Americans, causing sudden episodes of rapid heart rate and associated symptoms like palpitations and shortness of breath, particularly among young individuals during vigorous activities.
Product Details: CARDAMYST is a rapid-acting calcium channel blocker designed to treat acute episodes of PSVT, expected to be available in retail pharmacies by the first quarter of 2026.
Stock Performance: Following the announcement, Milestone Pharmaceuticals' stock experienced fluctuations, trading at $2.41 after reaching a 52-week high of $3.06.
FDA Grants Approval for Milestone Pharma's CARDAMYST, the First Self-Administered Therapy for PSVT
FDA Approval: Milestone Pharmaceuticals Inc. received FDA approval for CARDAMYST (etripamil) nasal spray, a treatment for acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) in adults.
Access to Treatment: The approval allows over two million Americans with PSVT to access a rapid-acting, self-administered treatment option outside of healthcare settings, enhancing their ability to manage episodes.
Product Availability: CARDAMYST is expected to be available in retail pharmacies starting in the first quarter of 2026.
Stock Performance: Following the announcement, MIST's stock closed at $2.41, a decline of 18.31%, but saw a slight recovery in after-hours trading to $2.46.
