{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-155885","form_type":"8-K","ticker":"KALV","cik":"0001348911","company_name":"KalVista Pharmaceuticals, Inc.","filed_at":"2025-07-07T23:59:59+00:00","discovered_at":"2026-05-14T18:02:43.794363+00:00","generated_at":"2026-05-18T09:15:37.494550+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"KalVista receives FDA approval for EKTERLY (sebetralstat), first oral on-demand HAE treatment","bullets":["FDA approved EKTERLY for acute attacks of hereditary angioedema in patients 12+ years; first oral on-demand therapy.","Phase 3 KONFIDENT trial (136 patients, 20 countries) showed faster symptom relief vs placebo; published in NEJM.","KONFIDENT-S open-label extension: median 10 minutes to treat attacks after onset; 1.3 hours to symptom relief for laryngeal/abdominal/breakthrough attacks.","Launching immediately; prescriptions available today; KalVista Cares patient support program launched.","CEO Ben Palleiko says EKTERLY has potential to become foundational HAE treatment; conference call at 8:30am ET."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-155885","json":"https://secwatch.observer/filing/0001193125-25-155885.json","markdown":"https://secwatch.observer/filing/0001193125-25-155885.md","text":"https://secwatch.observer/filing/0001193125-25-155885.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1348911/000119312525155885/0001193125-25-155885-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1348911/000119312525155885/d98157d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T09:15:37.494550+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"}