{"schema_version":"secwatch.filing_event.v1","accession":"0001564590-21-047970","form_type":"8-K","ticker":"KALV","cik":"0001348911","company_name":"KalVista Pharmaceuticals, Inc.","filed_at":"2021-09-15T23:59:59+00:00","discovered_at":"2026-05-14T18:04:17.795192+00:00","generated_at":"2026-06-29T03:27:40.512553+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA lifts clinical hold on KalVista's Phase 2 KVD824 trial for HAE prophylaxis","bullets":["FDA removed clinical hold on Phase 2 KOMPLETE trial of KVD824 for oral prophylactic treatment of hereditary angioedema.","Clinical hold lifted after FDA review of KalVista's responses on certain preclinical studies of KVD824.","Protocol refinements made; company working to resume study activities as soon as possible."],"urls":{"canonical":"https://secwatch.observer/filing/0001564590-21-047970","json":"https://secwatch.observer/filing/0001564590-21-047970.json","markdown":"https://secwatch.observer/filing/0001564590-21-047970.md","text":"https://secwatch.observer/filing/0001564590-21-047970.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1348911/000156459021047970/0001564590-21-047970-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1348911/000156459021047970/kalv-8k_20210914.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-29T03:27:40.512553+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"}