MOLBREEVI (Molgradex) - (IMPALA-2)

April 15, 2026: Savara Inc. (NASDAQ: SVRA) said the FDA extended the PDUFA review period by three months for the molgramostim BLA for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). The BLA is under Priority Review, and the new PDUFA target action date is November 22, 2026. The FDA stated the company’s responses to recent information requests constituted a “major amendment,” triggering the extension; the agency did not cite any safety, efficacy, or manufacturing concerns. Savara noted molgramostim has Fast Track and Breakthrough Therapy Designations in the U.S., Orphan Drug Designation from FDA and EMA for autoimmune PAP, and U.K. MHRA Innovation Passport and Promising Innovative Medicine designations.