Milestone Pharmaceuticals Receives FDA Approval for CARDAMYST, Benefiting Over 2 Million PSVT Patients
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 13 2025
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Source: Newsfilter
- First Self-Management Treatment: Milestone's CARDAMYST nasal spray receives FDA approval, providing over 2 million PSVT patients with the first rapid self-management treatment option, enabling them to quickly address arrhythmias at home and significantly improve their quality of life.
- Successful Clinical Trials: In clinical trials involving over 1,800 participants, CARDAMYST users were twice as likely to convert to sinus rhythm within 30 minutes compared to placebo, with a median conversion time of 17 minutes, demonstrating its effectiveness in acute episodes.
- Well-Capitalized for Commercialization: With $82.6 million in cash and short-term investments, along with a $75 million royalty purchase agreement with RTW Investments, Milestone is well-positioned to launch and commercialize CARDAMYST, expected to be available in retail pharmacies in Q1 2026.
- Future R&D Directions: Building on the success of the AFib-RVR trial, Milestone plans to initiate a Phase 3 clinical trial for CARDAMYST, further expanding its market potential, with an estimated addressable market of 3 to 4 million AFib patients by 2030.
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Analyst Views on MIST
Wall Street analysts forecast MIST stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for MIST is 8.00 USD with a low forecast of 8.00 USD and a high forecast of 8.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
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3 Buy
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Strong Buy
Current: 1.910
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8.00
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8.00
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8.00
Current: 1.910
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8.00
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8.00
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8.00
About MIST
Milestone Pharmaceuticals Inc. is a Canada-based biopharmaceutical company. The Company is focused on the development and commercialization of cardiovascular medicines. Its lead product candidate, etripamil, is a potent rapid-onset calcium channel blocker that the Company designed and is developing as a rapid-onset nasal spray to be administered by patients. The Company is also focused on developing etripamil to treat paroxysmal supraventricular tachycardia, atrial fibrillation, and other cardiovascular indications.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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.
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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.
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