{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-104929","form_type":"8-K","ticker":"LQDA","cik":"0001819576","company_name":"Liquidia Corp","filed_at":"2026-09-03T12:00:31+00:00","discovered_at":"2026-09-03T12:05:00.421334+00:00","generated_at":"2026-09-03T12:05:15.461520+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"FDA grants Fast Track to Liquidia's YUTREPIA for SSc-Raynaud's phenomenon","bullets":["FDA granted Fast Track designation to YUTREPIA (treprostinil) inhalation powder for systemic sclerosis-associated Raynaud's phenomenon (SSc-RP).","No therapy is currently FDA-approved for SSc-RP; condition affects up to 90% of systemic sclerosis patients.","Liquidia plans to initiate RE-WARM, a Phase 2a dose-finding study of YUTREPIA in SSc-RP, in Q4 2026.","Company estimates U.S. addressable population of ~30,000 moderate-to-severe SSc-RP patients.","Fast Track enables more frequent FDA interactions and potential rolling review and Priority Review eligibility."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-104929","json":"https://secwatch.observer/filing/0001104659-26-104929.json","markdown":"https://secwatch.observer/filing/0001104659-26-104929.md","text":"https://secwatch.observer/filing/0001104659-26-104929.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1819576/000110465926104929/0001104659-26-104929-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1819576/000110465926104929/tm2624724d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-03T12:05:15.461520+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"}