Milestone Pharmaceuticals has secured U.S. Food and Drug Administration approval for its etripamil nasal spray, CARDAMYST, on December 12, 2025. The approval clears the company’s lead product for commercial launch and marks a pivotal transition from a clinical‑stage biopharma to a revenue‑generating enterprise.
The approval was based on the Phase 3 RAPID trial, in which 64 % of patients who self‑administered CARDAMYST achieved conversion to sinus rhythm within 30 minutes, compared with 31 % on placebo. The study also reported a favorable safety profile, with no serious adverse events related to the drug.
Milestone will begin distribution through retail pharmacies in the first quarter of 2026. The FDA clearance triggers a $75 million royalty payment under the company’s Royalty Purchase Agreement with RTW Investments, and the company’s cash balance of $82.6 million as of September 30, 2025 provides a runway to support launch activities and early commercialization.
President and CEO Joseph Oliveto said the approval “opens a new chapter for patients who have long relied on emergency department visits for PSVT treatment.” He added that the company will use the momentum to advance a Phase 3 program for atrial fibrillation with rapid ventricular rate, leveraging the regulatory and commercial traction generated by CARDAMYST.
Paroxysmal supraventricular tachycardia affects an estimated 1 million adults in the United States, yet treatment options have largely required in‑hospital administration. CARDAMYST’s self‑administered nasal spray is the first at‑home therapy for PSVT, giving patients immediate control and potentially reducing emergency department utilization. The product’s unique delivery platform also positions Milestone ahead of any future competitors that may seek to enter the market.
The approval transforms Milestone’s business model, providing the first revenue stream and a clear path to profitability. The company’s cash runway, combined with the royalty payment, supports the capital intensity of launch and early marketing. However, the company will need to secure reimbursement coverage and build distribution partnerships to realize the full commercial potential, and it faces headwinds from the high cost of launch activities and the uncertainty of payer acceptance.
Investors have responded positively to the approval, viewing it as a major de‑risking event that validates the company’s scientific platform and commercial strategy. Analysts have highlighted the approval as a key milestone that could accelerate the company’s transition to a revenue‑generating entity.
Milestone will focus on securing reimbursement, establishing pharmacy distribution, and scaling its marketing efforts in the first quarter of 2026, while continuing to develop its atrial fibrillation pipeline. The company’s next steps will determine how quickly it can convert the regulatory win into sustained revenue growth.
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