Savara Receives FDA Refusal to File (RTF) Letter

 -Savara Inc. (Nasdaq: SVRA) (the Company), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, today announced that the Company received an RTF letter from the FDA for the BLA of MOLBREEVI as a therapy to treat patients with autoimmune PAP.

Upon preliminary review, the FDA determined that the BLA submitted in March 2025 was not sufficiently complete to permit substantive review and requested additional data related to Chemistry, Manufacturing, and Controls (CMC). The RTF was not the result of safety concerns, and the FDA did not request or recommend additional efficacy studies. Within the next 30 days, the Company intends to request a Type A meeting with the Agency. Typically, Type A meetings are granted by the FDA within 30 days of the request.

https://www.businesswire.com/news/home/20250527493563/en/Savara-Receives-Refusal-to-File-RTF-Letter-From-the-U.S.-Food-and-Drug-Administration-FDA-for-the-Biologics-License-Application-BLA-for-MOLBREEVI-to-Treat-Patients-With-Autoimmune-Pulmonary-Alveolar-Proteinosis-autoimmune-PAP