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KalVista Pharmaceuticals (KALV) FDA Events

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FDA Events for KalVista Pharmaceuticals (KALV)

This section highlights FDA-related milestones and regulatory updates for drugs developed by KalVista Pharmaceuticals (KALV). Over the past two years, KalVista Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as KONFIDENT, KONFIDENT-KID, KONFIDENT-S, and sebetralstat. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

KalVista Pharmaceuticals' Drugs in FDA Review

KONFIDENT - FDA Regulatory Timeline and Events

KONFIDENT is a drug developed by KalVista Pharmaceuticals for the following indication: Treatment of HAE attacks in adults and adolescents aged 12 years and older. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

KONFIDENT-KID - FDA Regulatory Timeline and Events

KONFIDENT-KID is a drug developed by KalVista Pharmaceuticals for the following indication: oral plasma kallikrein inhibitor, in pediatric patients between the ages of two and 11 with hereditary angioedema (HAE). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

KONFIDENT-S - FDA Regulatory Timeline and Events

KONFIDENT-S is a drug developed by KalVista Pharmaceuticals for the following indication: Treatment of hereditary angioedema (HAE) attacks in adult and pediatric patients aged 12 years and older. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

sebetralstat - FDA Regulatory Timeline and Events

sebetralstat is a drug developed by KalVista Pharmaceuticals for the following indication: Therapy for hereditary angioedema (HAE). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

KalVista Pharmaceuticals FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, KalVista Pharmaceuticals (KALV) has reported FDA regulatory activity for the following drugs: sebetralstat, KONFIDENT-S, KONFIDENT-KID and KONFIDENT.

The most recent FDA-related event for KalVista Pharmaceuticals occurred on July 7, 2025, involving sebetralstat. The update was categorized as "FDA Approval," with the company reporting: "KalVista Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has approved EKTERLY® (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. EKTERLY is the first and only oral on-demand treatment for HAE."

Current therapies from KalVista Pharmaceuticals in review with the FDA target conditions such as:

  • Therapy for hereditary angioedema (HAE). - sebetralstat
  • Treatment of hereditary angioedema (HAE) attacks in adult and pediatric patients aged 12 years and older. - KONFIDENT-S
  • oral plasma kallikrein inhibitor, in pediatric patients between the ages of two and 11 with hereditary angioedema (HAE). - KONFIDENT-KID
  • Treatment of HAE attacks in adults and adolescents aged 12 years and older. - KONFIDENT

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:KALV) was last updated on 7/10/2025 by MarketBeat.com Staff
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