Savara Resubmits MOLBREEVI BLA to FDA and Requests Priority Review

Savara Inc., a clinical stage biopharmaceutical company focused on rare respiratory diseases, has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI (molgramostim inhalation solution) for the potential treatment of autoimmune pulmonary alveolar proteinosis (autoimmune PAP). The resubmission names FUJIFILM Biotechnologies as the drug substance manufacturer, and Savara has requested Priority Review of the application. MOLBREEVI has previously been granted Fast Track and Breakthrough Therapy Designations by the FDA, Orphan Drug Designation by both the FDA and the European Medicines Agency $(EMA)$, and Innovation Passport and Promising Innovative Medicine designations by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) for this indication.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Savara Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251221214643) on December 22, 2025, and is solely responsible for the information contained therein.