{"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","discovered_at":"2026-05-14T18:02:47.666695+00:00","generated_at":"2026-05-20T10:14:41.971635+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Savara receives FDA Refusal to File for MOLBREEVI BLA; resubmission expected Q4 2025","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-126273","json":"https://secwatch.observer/filing/0001193125-25-126273.json","markdown":"https://secwatch.observer/filing/0001193125-25-126273.md","text":"https://secwatch.observer/filing/0001193125-25-126273.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-20T10:14:41.971635+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}