Savara Inc. (SVRA) announced that it has resubmitted the Biologics License Application to the FDA for MOLBREEVI, its investigational therapy currently in Phase 3 development, seeking approval for the treatment of autoimmune pulmonary alveolar proteinosis (autoimmune PAP).
Autoimmune PAP is a rare, chronic lung disease marked by the abnormal accumulation of surfactant in the alveoli. In healthy lungs, surfactant is cleared by alveolar macrophages, but in autoimmune PAP, antibodies neutralize granulocyte-macrophage colony-stimulating factor (GM-CSF), impairing macrophage function. This leads to impaired gas exchange and symptoms such as shortness of breath, cough, fatigue, and, in severe cases, lung fibrosis or the need for transplant.
MOLBREEVI (molgramostim inhalation solution) is a recombinant human GM-CSF delivered via PARI Pharma's proprietary eFlow Nebulizer System. The therapy is designed to restore macrophage function by replacing GM-CSF, thereby enabling clearance of excess surfactant. The company has requested Priority Review for the resubmission, which could accelerate FDA decision-making.
The investigational therapy has already received multiple regulatory designations, including Fast Track and Breakthrough Therapy from the FDA, Orphan Drug designation from both the FDA and EMA, and Innovation Passport and Promising Innovative Medicine designations from the UK's MHRA. These highlight the significant unmet need and potential impact of MOLBREEVI in treating autoimmune PAP.
In May of this year, the FDA refused to accept the MOLBREEVI BLA submitted in March 2025, citing that the application was incomplete for a substantive review and requested additional data on Chemistry, Manufacturing, and Controls.
The resubmitted BLA addresses the concerns raised by the U.S. regulatory agency while also reflecting the inclusion of FUJIFILM Biotechnologies as the drug substance manufacturer.
If approved, MOLBREEVI would represent the first targeted therapy for autoimmune PAP, offering patients a disease-modifying option beyond supportive care and invasive procedures like whole lung lavage.
SVRA has traded between $1.89 and $7.01 over the past year. The stock closed yesterday's trading at $6.47, up 6.94%.
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