Milestone Pharmaceuticals Eyes FDA Approval for CARDAMYST

Milestone Pharmaceuticals ( (MIST) ) has released its Q4 earnings. Here is a breakdown of the information Milestone Pharmaceuticals presented to its investors.

Milestone Pharmaceuticals Inc. is a biopharmaceutical company focused on developing and commercializing innovative cardiovascular solutions, particularly through its lead investigational product, etripamil, a novel nasal spray for heart conditions such as PSVT and AFib-RVR.

In its latest earnings report, Milestone Pharmaceuticals highlighted its progress towards the potential FDA approval of CARDAMYST, the brand name for etripamil, with a review goal date set for March 27, 2025. The company is preparing for a proposed mid-2025 launch, contingent on FDA approval, and has secured resources to support commercialization efforts.

Key financial metrics from the report indicate that Milestone ended 2024 with $69.7 million in cash and investments, a slight increase from the previous year. The company reported no revenue for 2024, compared to $1 million in 2023, due to a milestone payment received in the prior year. Research and development expenses decreased significantly, reflecting the completion of Phase 3 studies, while general and administrative expenses saw a slight increase. Milestone’s net loss for 2024 was $41.5 million, an improvement from the $59.7 million loss in 2023.

Strategically, Milestone is advancing its clinical programs, with plans to initiate a Phase 3 trial for etripamil in AFib-RVR in 2025. The company also received a Notice of Allowance for a new patent, potentially extending CARDAMYST’s intellectual property protection in the U.S. until 2042.

Looking ahead, Milestone Pharmaceuticals remains focused on achieving FDA approval for CARDAMYST and executing its commercialization strategy. The company is well-capitalized to support these efforts and continues to explore opportunities to enhance its product portfolio and address unmet patient needs in the cardiovascular space.