secwatch.observer — SEC 8-K summary
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Issuer:     KalVista Pharmaceuticals, Inc. (KALV)
CIK:        0001348911
Form:       8-K
Filed at:   2024-09-05T23:59:59+00:00
Accession:  0000950170-24-104032
Event type: earnings
Sentiment:  neutral
Materiality: 0.75
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

KalVista Q1 net loss $40.4M; FDA accepts NDA for sebetralstat, PDUFA June 17, 2025
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- Net loss $40.4M ($0.87/share) vs $25.3M prior year; no revenue recognized.
- Cash and securities $174.3M at July 31, down from $210.4M on April 30.
- FDA accepted NDA for oral sebetralstat for HAE; PDUFA goal date June 17, 2025.
- EMA validated MAA submission for sebetralstat; UK/Japan filings planned later in 2024.
- Phase 3 KONFIDENT-KID pediatric trial initiated dosing with oral disintegrating tablet.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1348911/000095017024104032/0000950170-24-104032-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1348911/000095017024104032/kalv-20240905.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-104032

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