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].

Group 1 - Savara Inc. shares fell over 30% in intraday trading on May 27, 2025, following the FDA's issuance of a Refusal to File letter for its Biologics License Application for Molbreevi, its lead drug candidate for autoimmune PAP [2] - The FDA cited that the submission was "not sufficiently complete" for review, specifically pointing out issues with the CMC section of the application, and Savara was unable to specify what data was missing or why deficiencies were not addressed prior to submission [2] Group 2 - Block & Leviton is investigating Savara Inc. for potential securities law violations and may file an action to recover losses for investors [4] - Investors who have lost money in Savara Inc. investments are encouraged to contact Block & Leviton to learn more about recovery options [5][3] Group 3 - Block & Leviton is recognized as a leading securities class action firm, having recovered billions of dollars for defrauded investors and representing many top institutional investors [7]