Free Trial

Kezar Life Sciences (KZR) FDA Events

Kezar Life Sciences logo
$4.35 -0.11 (-2.47%)
Closing price 04:00 PM Eastern
Extended Trading
$4.36 +0.01 (+0.11%)
As of 04:13 PM Eastern
Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more.

Kezar Life Sciences' Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Kezar Life Sciences (KZR). Over the past two years, Kezar Life Sciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as zetomipzomib and Zetomipzomib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

Zetomipzomib FDA Regulatory Timeline and Events

Zetomipzomib is a drug developed by Kezar Life Sciences for the following indication: In Patients with Autoimmune Hepatitis. 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.

Zetomipzomib (LN) FDA Regulatory Events

Zetomipzomib (LN) is a drug developed by Kezar Life Sciences for the following indication: Lupus Nephritis (LN). 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.

Kezar Life Sciences FDA Events - Frequently Asked Questions

In the past two years, Kezar Life Sciences (KZR) has not received FDA approval for any therapies. However, the company does have drugs under review or in active clinical development.

In the past two years, Kezar Life Sciences (KZR) has reported FDA regulatory activity for the following drugs: zetomipzomib and Zetomipzomib (LN).

The most recent FDA-related event for Kezar Life Sciences occurred on July 15, 2025, involving zetomipzomib. The update was categorized as "Lifted Clinical Hold," with the company reporting: "Kezar Life Sciences, Inc. announced that the Division of Hepatology and Nutrition of the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the completed PORTOLA Phase 2a clinical trial evaluating zetomipzomib, a first-in-class selective immunoproteasome inhibitor, in patients with autoimmune hepatitis (AIH)."

Current therapies from Kezar Life Sciences in review with the FDA target conditions such as:

  • In Patients with Autoimmune Hepatitis - zetomipzomib
  • Lupus Nephritis (LN) - Zetomipzomib (LN)

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:KZR) was last updated on 7/18/2025 by MarketBeat.com Staff
From Our Partners