Milestone Pharmaceuticals Inc. (MIST) has received FDA approval 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 exceeding 250 beats per minute, that occur suddenly and then stop. It is most common among young people and may occur during vigorous exercise. Some of the symptoms associated with Paroxysmal supraventricular tachycardia (PSVT) include palpitations, sweating, chest pressure or pain, shortness of breath, sudden onset of fatigue, fainting, and anxiety.
CARDAMYST nasal spray is a novel and rapid-acting calcium channel blocker delivered when needed to treat often highly symptomatic and unpredictable episodes of PSVT. This approval marks the first time that PSVT patients will have a rapid-acting treatment option they can self-administer outside the emergency department or other healthcare setting. The product, which is the first FDA-approved treatment in over 30 years for PSVT, is expected to be available in retail pharmacies in the first quarter of 2026.
The company is scheduled to hold a Conference call and webcast on Monday, December 15, 2025, at 8:00 a.m. ET.
When we alerted readers to MIST on January 29, 2025, it was trading around $1.98. The stock, which touched a 52-week high of $3.06 during intraday trading on Friday (Dec.12, 2025), closed the day at $2.41, down 18.31%.
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