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Milestone Pharmaceuticals FDA Announcement summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.FDA Announcement summary15 Dec, 2025
Introduction and purpose
FDA approved Cardamyst (etripamil) nasal spray as the first new, self-administered treatment for PSVT in over 30 years, addressing a significant unmet need for over 2 million Americans.
The product is a novel, short-acting calcium channel blocker designed for rapid, on-demand self-administration outside healthcare settings.
Details of approval or decision
Cardamyst is indicated for acute treatment of PSVT in adults, approved for intranasal use only, with each device delivering a 70 mg dose via two sprays.
The FDA label met or exceeded expectations, with a clean safety and tolerability profile and no major surprises.
Patent protection extends until 2042, supporting long-term market exclusivity.
Impact on industry and stakeholders
Cardamyst is expected to become the new standard of care, reducing emergency department visits and improving patient quality of life.
Over 2 million patients diagnosed with PSVT in the US, costing the healthcare system at least $5 billion annually.
No anticipated branded competition and a low barrier to prescribing are expected to drive strong demand and minimal rebate pressure.
The launch targets 10,000 key healthcare providers, primarily cardiologists and electrophysiologists, with an initial sales force of 60 representatives.
Expected to be available in retail pharmacies in Q1 2026.
Confirm receipt of $75M royalty financing
AFib-RVR Phase 3 study initiation timing
Update on CARDAMYST insurance coverage efforts
What factors influence net revenue per script?
How will patient compliance be ensured?
Which prescriber segment will adopt fastest?
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Next Milestone Pharmaceuticals earnings date
Q4 202520 Mar, 2026
Next Milestone Pharmaceuticals earnings date
Q4 202520 Mar, 2026
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Frequently asked questions
Milestone Pharmaceuticals Inc. is a biopharmaceutical company focused on developing cardiovascular therapies. The company specializes in the research and development of treatments for episodic cardiovascular conditions, aiming to provide rapid and effective symptom relief. Its lead drug candidates target conditions such as paroxysmal supraventricular tachycardia (PSVT) and other heart-related disorders. The company is headquartered in Montreal, Canada, and its shares are listed on the NASDAQ.
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