Savara Inc. announced that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) of MOLBREEVI for autoimmune pulmonary alveolar proteinosis (aPAP). The FDA determined the BLA was not sufficiently complete for substantive review.
The FDA specifically requested additional data related to Chemistry, Manufacturing, and Controls (CMC). Importantly, the RTF was not a result of safety concerns, and the FDA did not request or recommend additional efficacy studies for MOLBREEVI.
Savara intends to request a Type A meeting with the FDA within 30 days to align on next steps and expects to resubmit the BLA in the fourth quarter of 2025. The company remains confident in its program and the clinical data demonstrating MOLBREEVI's benefits.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.