Core Insights - The FDA has accepted a New Drug Application (NDA) for a new formulation of Lantheus' F 18 PSMA imaging agent, with a PDUFA date set for March 6, 2026 [1][2][3] - The new formulation aims to increase batch size by approximately 50%, enhancing patient access and supply resilience [1][3] - PYLARIFY, the current market-leading PSMA PET imaging agent, has shown an 86% median true-positive rate in diagnosing recurrent prostate cancer [2][3] Company Developments - Lantheus is focused on advancing prostate cancer imaging through sustainable innovation, with the new formulation expected to improve patient access and streamline operations [3][4] - The new formulation is designed to optimize the manufacturing process, increasing the radioactive concentration of the agent [3] - The company has a strong market presence, with PYLARIFY being the number one ordered PSMA PET imaging agent in the U.S., supported by over 500,000 scans [6] Industry Context - Prostate cancer is the second most frequently diagnosed cancer in the U.S., with estimates suggesting nearly 315,000 new cases and over 35,000 deaths in 2025 [4] - Projections indicate that annual prostate cancer cases could nearly double to 2.9 million by 2040, driven by aging populations and increased life expectancy [4] - The growing burden of prostate cancer highlights the need for accurate and early detection methods, positioning Lantheus for continued leadership in this area [3][4]