Business
Milestone Pharmaceuticals Reports Second Quarter 2024 Financial Results and Provides Regulatory and Corporate Update
– NDA for CARDAMYST™ in PSVT accepted by FDA in 2Q 2024; PDUFA in March 2025 – Cash of $83.3 million as of June 30, 2024 expected to fund operations into 2026
About this update from Milestone Pharmaceuticals Inc.
[{"type":"text","content":"– NDA for CARDAMYST™ in PSVT accepted by FDA in 2Q 2024; PDUFA in March 2025 – Cash of $83.3 million as of June 30, 2024 expected to fund operations into 2026 – Stuart Duty and Andrew Saik Appointed as Independent Board Directors MONTREAL and CHARLOTTE, N.C., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the second quarter ended June 30, 2024 and provided a regulatory and corporate update. “The FDA acceptance of our New Drug Application (NDA) for CARDAMYST™ (etripamil) nasal spray (an investigational new drug), has enabled our commercial team to advance preparations for potential approval and launch in 2025,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “Further, we are encouraged by the interest and input from cardiology experts in our Phase 3 AFib-RVR study that we plan to commence in the first half of 2025.” Second Quarter and Recent Program Updates CARDAMYST for patients with paroxysmal supraventricular tachycardia (PSVT) FDA accepted the NDA of CARDAMYST for PSVT. On May 26, 2024, the U.S. Food and Drug Administration (FDA) accepted the resubmission of the NDA for CARDAMYST. The FDA Prescription Drug User Fee Act (PDUFA) target date has been set for March 2025.Milestone hosted a KOL webinar entitled “Learnings from the Field: Expert Perspectives on Managing PSVT in the Community Setting.” The event, which is the first of a series of planned webinars learning from community-based health care providers, featured George Mark, MD, FACC and Vivek Sailam, MD from The Heart House and Cooper University Health Care. Both physicians discussed the burden of PSVT on patients and their practice, current treatments and unmet needs, and expectations for how the treatment landscape is likely to evolve in coming years. A replay of the webinar is available on the Milestone corporate website here. The second event of the webcast series is planned for this Fall. Etripamil for patients with atrial fibrillation with rapid ventricular rate (AFib-RVR) Planning and Design of Phase 3 pivotal trial is ongoing, following guidance received from FDA in 1Q 2024 meeting. Milestone is working with experts to finalize the design of a Phase 3 trial for etripamil in AFib-RVR. The Company plans to propose to the FDA a Phase 3 clinical study, condu...