Savara is a clinical-stage biopharmaceutical company with a single pipeline asset: MOLBREEVI (molgramostim), an inhaled biologic in development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP), a rare lung disease in which the immune system blocks GM-CSF, impairing the macrophages that clear surfactant from the lungs. Without treatment, surfactant accumulates, causing progressive respiratory failure. The current standard of care is whole lung lavage, an invasive procedure performed under general anesthesia that physically washes surfactant from the lungs but does not address the underlying disease. MOLBREEVI delivers recombinant human GM-CSF directly to the lungs via a nebulizer once daily, aiming to restore macrophage function and treat the root cause. Savara has no revenue and is entirely pre-commercial, with spending focused on clinical development and regulatory activities. If approved, Savara would sell MOLBREEVI as a chronic, long-term therapy to a small, concentrated patient population treated by pulmonologists at specialist centers. Savara operates an asset-light model, outsourcing manufacturing, testing, and device supply to partners including Fujifilm, Patheon, and PARI. Savara submitted a BLA to the FDA, received a Refusal to File related to manufacturing issues, resubmitted in December 2025, and in February 2026 the FDA accepted the BLA and granted Priority Review. MOLBREEVI holds Breakthrough Therapy, Fast Track, and Orphan Drug Designations in the U.S., providing up to 12 years of market exclusivity if approved.