Savara Announces FDA Files For Review Of Biologics License Application For MOLBREEVI As Autoimmune Pulmonary Alveolar Proteinosis Treatment; Sets Aug. 22 As Prescription Drug User Fee Act Target Action Date

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.

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.