The U.S. Food and Drug Administration has extended the review period for Savara Inc.'s (NASDAQ: SVRA) molgramostim inhalation solution by three months, pushing the target action date to November 22, 2026.

The FDA determined that Savara's responses to recent information requests constituted a major amendment to the Biologics License Application, triggering the three-month extension under the Prescription Drug User Fee Act. The agency did not cite safety, efficacy, or manufacturing concerns in its correspondence with the Pennsylvania-based biopharmaceutical company.

Molgramostim is under review for the treatment of autoimmune pulmonary alveolar proteinosis, a rare lung disease. The FDA is conducting the review under Priority Review status, which typically shortens the standard review timeline.

The drug has received multiple regulatory designations including Fast Track and Breakthrough Therapy designations from the FDA, as well as Orphan Drug Designation from both the FDA and the European Medicines Agency. The U.K.'s Medicines and Healthcare Products Regulatory Agency has granted it Innovation Passport and Promising Innovative Medicine designations.

Autoimmune PAP affects the lungs' ability to clear surfactant, a substance that prevents lung collapse. In patients with the condition, antibodies neutralize granulocyte-macrophage colony-stimulating factor, impairing immune cells' ability to clear excess surfactant from lung air sacs.

Savara's molgramostim is a recombinant human granulocyte-macrophage colony-stimulating factor delivered through an investigational nebulizer system developed specifically for inhaling large molecules. The company focuses on developing treatments for rare respiratory diseases.