LANGHORNE, PA — The U.S. Food and Drug Administration has extended the review period for Savara Inc.’s (Nasdaq: SVRA) biologics license application for molgramostim by three months, setting a new target action date of November 22, 2026.
The application is under Priority Review for the treatment of autoimmune pulmonary alveolar proteinosis, a rare lung disease.
The FDA determined that Savara’s responses to recent information requests constituted a major amendment to the application, triggering the extension.
The agency did not identify any concerns related to safety, efficacy, or manufacturing in its communication.
The extension allows additional time for the FDA to review recently submitted materials tied to the application.
Molgramostim has received Fast Track and Breakthrough Therapy designations in the United States, as well as Orphan Drug designation from both the FDA and the European Medicines Agency.
The therapy has also received Innovation Passport and Promising Innovative Medicine designations from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency.
Autoimmune pulmonary alveolar proteinosis is a condition in which surfactant accumulates in the lungs due to impaired clearance by immune cells, leading to reduced gas exchange and symptoms including shortness of breath and fatigue.
Savara is developing molgramostim as an inhaled therapy using a nebulizer system for patients with the disease.
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