Savara receives FDA Refusal to File for MOLBREEVI BLA; resubmission expected Q4 2025

Savara Inc

FDA requested additional CMC data; RTF not due to safety or efficacy concerns.
Company plans Type A meeting within 30 days to align on next steps.
BLA for autoimmune PAP was submitted March 2025; resubmission targeted for Q4 2025.
Technology transfer for second-source drug substance manufacturer on track; three PPQ batches completed.
MOLBREEVI retains Fast Track, Breakthrough Therapy, and Orphan Drug status.

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