{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-25-012825","form_type":"8-K","ticker":"XAIR","cik":"0001641631","company_name":"Beyond Air, Inc.","filed_at":"2025-09-08T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.545443+00:00","generated_at":"2026-05-17T07:37:01.358623+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"NeuroNOS (Beyond Air unit) receives FDA Orphan Drug Designation for BA-101 in glioblastoma","bullets":["FDA grants Orphan Drug Designation for BA-101, an investigational nNOS inhibitor, for treatment of glioblastoma.","This is NeuroNOS's second orphan drug designation; ODD provides tax credits, fee waivers, and 7-year market exclusivity if approved.","GBM median survival is <12 months; standard of care (surgery, radiation, temozolomide) is not curative.","NeuroNOS CEO cites urgent unmet need and NO modulation strategy; preclinical data showed NOS inhibition reduced GBM cell proliferation.","Company plans to advance BA-101 toward first-in-human studies."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-25-012825","json":"https://secwatch.observer/filing/0001493152-25-012825.json","markdown":"https://secwatch.observer/filing/0001493152-25-012825.md","text":"https://secwatch.observer/filing/0001493152-25-012825.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1641631/000149315225012825/0001493152-25-012825-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1641631/000149315225012825/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T07:37:01.358623+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"}