---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-126273"
form_type: "8-K"
ticker: "SVRA"
cik: "0001160308"
company_name: "Savara Inc"
filed_at: "2025-05-27T23:59:59+00:00"
generated_at: "2026-05-20T10:14:41.971635+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-25-126273
- form_type: 8-K
- ticker: SVRA
- cik: 0001160308
- company_name: Savara Inc
- filed_at: 2025-05-27T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1160308/000119312525126273/0001193125-25-126273-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1160308/000119312525126273/d845572d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-126273
- JSON: https://secwatch.observer/filing/0001193125-25-126273.json
- Plain text: https://secwatch.observer/filing/0001193125-25-126273.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.