secwatch.observer — SEC 8-K summary
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Issuer:     KalVista Pharmaceuticals, Inc. (KALV)
CIK:        0001348911
Form:       8-K
Filed at:   2024-02-13T23:59:59+00:00
Accession:  0001193125-24-032859
Event type: other_material
Sentiment:  positive
Materiality: 0.90
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

KalVista announces positive Phase 3 KONFIDENT results; sebetralstat meets all endpoints with rapid symptom relief
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- Sebetralstat 300 mg achieved beginning of symptom relief in median 1.61 hours vs placebo 6.72 hours (p<0.0001).
- Trial met all primary and key secondary endpoints; no treatment-related SAEs and no withdrawals due to AEs.
- Treatment-related adverse event rates: 2.3% for 300 mg, 2.2% for 600 mg, 4.8% for placebo.
- Plan to submit NDA to U.S. FDA in first half of 2024 and in EU and Japan later in 2024.
- Largest HAE trial ever with 136 patients from 66 sites across 20 countries.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1348911/000119312524032859/0001193125-24-032859-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1348911/000119312524032859/d785380d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-032859

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer