RECORDATI ANNOUNCES STRATEGIC COLLABORATION WITH MODERNA TO DEVELOP AND COMMERCIALIZE WORLDWIDE mRNA 3927 FOR THE TREATMENT OF PROPIONIC ACIDEMIA

Core Viewpoint - Recordati has entered into a collaboration and license agreement with Moderna to develop and commercialize mRNA-3927, an investigational product for treating propionic acidemia, leveraging Moderna's mRNA technology and Recordati's commercial infrastructure [1][6]. Group 1: Collaboration Details - The agreement allows Moderna to lead the development of mRNA-3927, while Recordati will handle global commercialization if the product is approved [1]. - Recordati will pay Moderna an upfront payment of USD 50 million, with potential additional payments of up to USD 110 million based on development and regulatory milestones [4]. - The transaction is subject to customary closing conditions, including U.S. antitrust clearance expected within 30 days [5]. Group 2: Product Information - mRNA-3927 aims to restore propionyl-CoA carboxylase (PCC) enzyme activity in patients with propionic acidemia, a rare inherited metabolic disorder characterized by toxic metabolite buildup [2][7]. - Interim clinical data published in Nature indicates early signs of clinical improvement, with a potential data readout expected by the end of 2026 [3][10]. - mRNA-3927 is designed as a targeted disease-modifying therapy and is currently in a registrational clinical study to reduce metabolic decompensation events [3][10]. Group 3: Market Context - Propionic acidemia affects approximately 1 in 100,000-150,000 individuals globally and currently lacks effective therapies targeting the disease's root cause [7]. - The collaboration aims to address the significant unmet medical need for disease-modifying treatment options in this patient population [6].