Milestone Pharmaceuticals Surges into New Era with FDA Approval of CARDAMYST
Milestone Pharmaceuticals, a leading pharmaceutical company, marked a significant milestone in its journey by securing FDA approval for CARDAMYST, an etripamil nasal spray for paroxysmal supraventricular tachycardia (PSVT), also known as the conversion of PSVT to normal sinus rhythm in adults.
The approval, announced in December 2025, represents a transformative event for the company as it enters a new phase of growth, focusing on bringing this innovative therapy to patients and building a strong commercial franchise.
According to Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals, the FDA approval is the culmination of years of clinical development and scientific commitment. He expressed his appreciation for the hard work and dedication of the clinical trial investigators, clinical support staff, partners, patients, and colleagues in bringing CARDAMYST to market.
The company's commercial strategy this year is centered on driving new patient starts, achieving commercial coverage, and ensuring patients have a good initial experience with CARDAMYST. While only about a month into the launch, Milestone Pharmaceuticals is encouraged by the initial feedback from prescribers, as shared by Lorenz Muller, Chief Commercial Officer.
In addition to its commercial endeavors, the FDA approval of CARDAMYST will enable Milestone Pharmaceuticals to leverage its comprehensive clinical data and seek marketing approvals in other parts of the world. The company has filed a Marketing Authorization Application (MAA) for etripamil nasal spray, known as TACHYMIST in Europe, which is currently under review by the European Medicines Agency (EMA).
Milestone Pharmaceuticals' financials also show promise, with the company reporting a strengthened balance sheet that supports its successful launch of CARDAMYST and provides an expected operating runway into late 2027.
