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Savara's Molbreevi Receives FDA Priority Review with August 22 PDUFA Date for Autoimmune PAP

Mar 02, 2026

The FDA has accepted Savara's Biologics License Application for Molbreevi in autoimmune pulmonary alveolar proteinosis, granted priority review, and set a PDUFA action date of August 22, 2026. The company plans to file marketing authorization applications in the EU and UK by the end of March.

FDA Accepts Savara's MOLBREEVI Application for Rare Lung Disease with August Decision Date

Feb 16, 2026

Savara Inc. announced the FDA has accepted its resubmitted Biologics License Application for MOLBREEVI, a treatment for autoimmune pulmonary alveolar proteinosis, with Priority Review granted and a target decision date of August 22, 2026.