Savara Receives FDA Day 74 Letter for MOLBREEVI, Submits MAA to EMA for Autoimmune PAP Treatment

Savara Inc. has received a Day 74 Letter from the FDA for its MOLBREEVI Biologics License Application (BLA) for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). The review is ongoing with a PDUFA target action date of August 22, 2026. The company has also submitted the MAA to the EMA and is on track to submit to the UK's MHRA by Q1 2026. MOLBREEVI has been granted Fast Track, Breakthrough Therapy, and Orphan Drug Designations by the FDA and EMA.