Core Viewpoint - Savara Inc. received a U.S. FDA refusal to file (RTF) letter regarding its Biologic License Application (BLA) for Molbreevi, a treatment for autoimmune Pulmonary Alveolar Proteinosis (PAP) [1][3]. Group 1: FDA Response - The FDA determined that the BLA submitted in March 2025 was not sufficiently complete for substantive review and requested additional data related to Chemistry, Manufacturing, and Controls (CMC) [3]. - The RTF did not arise from safety concerns, and the FDA did not request additional efficacy studies [3]. Group 2: Company Response and Future Plans - The company plans to request a Type A meeting with the FDA within 30 days to discuss the next steps [3]. - The requested CMC data outlined in the RTF letter are currently being generated, and the company is confident in addressing the FDA's request [4]. - The company expects to resubmit the BLA in the fourth quarter of 2025 and remains confident in the clinical data supporting Molbreevi's efficacy [4]. Group 3: Operational Updates - The company is working to establish a redundant supply chain and is on track to complete technology transfer with a second-source drug substance contract manufacturer in the fall [4]. - The company has completed three upstream process performance qualification (PPQ) batches and is in the process of completing the downstream PPQ campaign [4]. Group 4: Market Reaction - Following the news, SVRA stock declined by 28.9%, trading at $2.02 [4].