Savara Inc.

Savara Inc. is a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel, best-in-class medicines for rare respiratory diseases. The company's mission is to become a leader in this therapeutic area by addressing significant unmet medical needs. Savara Inc. is headquartered in Langhorne, Pennsylvania.

Savara's primary product candidate is molgramostim, also known as MOLBREEVI*, an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF). This therapy is currently in Phase 3 development for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP), a rare lung disease characterized by surfactant accumulation in the alveoli. MOLBREEVI* is designed for once-daily inhalation via an investigational eFlow® Nebulizer System (PARI Pharma GmbH).

Recent developments include the U.S. Food & Drug Administration (FDA) extending the review period for the molgramostim Biologics License Application (BLA) in aPAP, with a Prescription Drug User Fee Act (PDUFA) target action date of August 22, 2026. The company has also seen its Marketing Authorisation Applications (MAAs) for MOLBREEVI* accepted by the European Medicines Agency (EMA) and the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA). MOLBREEVI* holds Fast Track, Breakthrough Therapy, and Orphan Drug designations. Matt Pauls serves as the Chair of the Board of Directors and Chief Executive Officer, leading the company as it transitions from a clinical to a commercial entity, aiming to provide the first pharmacologic treatment option for aPAP.