Milestone® Pharmaceuticals Inc. (MIST) announced that the FDA has accepted for review the company’s response to the Complete Response Letter for CARDAMYST™ (etripamil) nasal spray, an investigational therapy for treating paroxysmal supraventricular tachycardia (PSVT).
Milestone Pharmaceuticals Inc. (MIST) also announced the extension of its $75.0 million Royalty Purchase Agreement with RTW Investments, LP and affiliates until December 31, 2025.
The FDA set a new PDUFA target action date of December 13, 2025. Proceeds from this royalty agreement are expected to support the planned launch of CARDAMYST following FDA approval and customary closing conditions.