Savara Inc.

Savara Inc. is a clinical stage biopharmaceutical company focused on rare respiratory diseases. The company's sole program is molgramostim inhalation solution, also known as MOLBREEVI, which is an investigational inhaled biologic. MOLBREEVI is an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). This solution is delivered using a proprietary eFlow® Nebulizer System from PARI Pharma GmbH. Savara's strategy involves advancing the MOLBREEVI autoimmune PAP program, including the completion of the Phase 3 IMPALA-2 pivotal clinical trial, for which the 96-Week open-label period is ongoing, and pursuing regulatory approval. The IMPALA-2 trial design was endorsed by regulatory authorities in the U.S. (U.S. Food and Drug Administration), Europe (European Medicines Agency), United Kingdom (Medicines and Healthcare Products Regulatory Agency), and Japan (Pharmaceuticals and Medical Devices Agency), as well as regulatory agencies and ethics committees in various countries and sites where the trial is being conducted. The IMPALA-2 trial enrolled 164 patients, exceeding its target enrollment of 160 patients, making it the largest placebo-controlled trial in autoimmune PAP. In June 2024, positive top-line results from the trial were reported, showing a favorable risk-benefit profile for MOLBREEVI in autoimmune PAP. A biologics license application (BLA) for MOLBREEVI in autoimmune PAP was submitted to the U.S. Food and Drug Administration (FDA) in March 2025. In May 2025, the company received a Refusal to File letter from the FDA, which was not due to safety concerns and did not request or recommend additional efficacy studies, nor did it impact previous designations. The BLA was resubmitted in December 2025 with a request for Priority Review. In February 2026, the FDA formally filed the BLA for MOLBREEVI and granted Priority Review.