{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-200742","form_type":"8-K","ticker":"KALV","cik":"0001348911","company_name":"KalVista Pharmaceuticals, Inc.","filed_at":"2025-09-11T23:59:59+00:00","discovered_at":"2026-05-14T18:02:43.795142+00:00","generated_at":"2026-05-17T06:51:47.541012+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"KalVista Q1: EKTERLY approved in US/UK; 460 patient start forms; positive CHMP opinion","bullets":["EKTERLY (sebetralstat) FDA approved July 7, 2025; UK MHRA authorized same month; positive CHMP opinion; EU decision expected Oct 2025.","Received 460 patient start forms through August 29, 2025 (nearly 5% of US HAE patients).","Net product revenue $1.4M from US sales; R&D expenses $15.2M (down 43% YoY); SG&A $44.7M (up 154% YoY due to commercialization).","Cash and marketable securities $191.5M as of July 31, 2025; runway into 2027.","Orphan designation maintained in EU; 10 years market exclusivity; one of only two HAE medicines with orphan status."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-200742","json":"https://secwatch.observer/filing/0001193125-25-200742.json","markdown":"https://secwatch.observer/filing/0001193125-25-200742.md","text":"https://secwatch.observer/filing/0001193125-25-200742.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1348911/000119312525200742/0001193125-25-200742-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1348911/000119312525200742/d12074d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T06:51:47.541012+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"}