Savara Inc

Savara Inc. (NASDAQ: SVRA) is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for rare respiratory diseases. The company's website is www.savara.com.

Savara's pipeline consists of a single product candidate, molgramostim inhalation solution, branded as MOLBREEVI, an investigational inhaled biologic formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). The drug is delivered via a proprietary eFlow Nebulizer System manufactured by PARI Pharma GmbH under an exclusive license agreement. MOLBREEVI is administered once daily via inhalation and represents the company's sole development program.

Autoimmune PAP is a rare lung disease characterized by the accumulation of surfactant in the lungs' air sacs, affecting approximately six to seven cases per million people in the United States, with higher prevalence reported in other regions including Japan. Currently, no approved pharmaceutical treatments exist for autoimmune PAP in the United States or Europe, with whole lung lavage representing the only available therapeutic option—an invasive procedure requiring general anesthesia and hospitalization.

The company's MOLBREEVI program has received significant regulatory recognition, including Fast Track Designation, Breakthrough Therapy Designation, and Orphan Drug Designation from the U.S. Food and Drug Administration, as well as corresponding designations from the European Medicines Agency and UK Medicines and Healthcare Products Regulatory Agency. In June 2024, Savara announced positive top-line results from its Phase 3 IMPALA-2 pivotal trial, which enrolled 164 patients across 43 sites in 16 countries, making it the largest placebo-controlled trial conducted in autoimmune PAP. The trial demonstrated statistically significant improvements in lung function and clinical benefit measures. In February 2026, the FDA formally filed the biologics license application for MOLBREEVI and granted Priority Review status.

Savara operates under an asset-light business model, outsourcing manufacturing, clinical development, and other capital-intensive operations to specialized vendors and contract research organizations. The company does not operate its own manufacturing facilities and relies entirely on third-party manufacturers for drug substance, drug product, and device components.