Milestone Pharmaceuticals Inc. has set a PDUFA target date of December 13, 2025, for their nasal spray, CARDAMYST™, used in treating PSVT. They plan to launch quickly upon potential FDA approval, with $82.6 million in cash to support it. Recent data presented at AHA shows promising results for etripamil in PSVT treatment.

Etripamil, a calcium channel blocker nasal spray, is under review by the FDA for PSVT treatment with a PDUFA date of December 13, 2025. Milestone Pharmaceuticals is well-prepared for a potential launch with recent financing and a strong clinical trial program. The company also has plans for a Phase 3 study in AFib-RVR following the success of the ReVeRA Phase 2 trial.

Milestone Pharmaceuticals Inc. is financially stable with $82.6 million in cash as of September 30, 2025. They reported no revenue for the third quarter but have strengthened their commercialization capabilities for the potential launch of CARDAMYST. The company’s net loss for the quarter was $11.9 million, compared to $9.4 million in the prior year period.

Etripamil is Milestone’s lead investigational product for PSVT and AFib-RVR. It is designed as a self-administered nasal spray for rapid response therapy. If approved, etripamil could provide patients with more control over their condition. Milestone Pharmaceuticals focuses on developing innovative cardiovascular solutions for complex heart conditions, with a strong emphasis on patient self-management.

Read more at GlobeNewswire: Milestone Pharmaceuticals Reports Third Quarter 2025