Savara Inc. (Nasdaq: SVRA) (the Company), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, announced the FDA has filed for review the BLA for MOLBREEVI as a therapy to treat patients with autoimmune PAP. The FDA granted Priority Review with a PDUFA action date of August 22, 2026.

“The FDA’s filing of the BLA marks another significant milestone for Savara and the autoimmune PAP community and brings us one step closer to a potential approval in the U.S. in August of this year,” said Matt Pauls, Chair and Chief Executive Officer, Savara. “We believe the considerable body of data in the application demonstrates MOLBREEVI improves pulmonary gas transfer, quality of life, and the clinical symptoms associated with this rare and debilitating lung disease. We are grateful to the FDA for the constructive feedback they have provided throughout development and the review process to date and look forward to continued dialogue with the Agency.”

FDA Priority Review designation directs overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard review applications.¹

In addition to Fast Track and Breakthrough Therapy Designations, MOLBREEVI has been granted Orphan Drug Designation for the treatment of autoimmune PAP by the FDA and the EMA, as well as Innovation Passport (IP) and Promising Innovative Medicine (PIM) designations by the UK’s MHRA.