Savara Receives European Medicines Agency Validation For Submission Of MOLBREEVI MAA In Autoimmune Pulmonary Alveolar Proteinosis
Benzinga Newsdesk 7 months ago
News
Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that the EMA has validated the submission of the MOLBREEVI MAA in autoimmune PAP;
Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that the EMA has validated the submission of the MOLBREEVI MAA in autoimmune PAP; the submission will now be reviewed by the Committee for Medicinal Products for Human Use (CHMP). In the U.S., the FDA is reviewing the MOLBREEVI BLA under Priority Review with an August 22, 2026 Action Date.