Welcome to our dedicated page for Kezar Life Sciences news (Ticker: KZR), a resource for investors and traders seeking the latest updates and insights on Kezar Life Sciences stock.
Kezar Life Sciences, Inc. (Nasdaq: KZR) is a clinical-stage biopharmaceutical company developing novel small molecule therapeutics for immune-mediated diseases, with a primary focus on its lead candidate zetomipzomib. The KZR news feed on Stock Titan aggregates company-issued press releases and other coverage so readers can follow how Kezar’s clinical programs and corporate decisions evolve over time.
Much of Kezar’s recent news centers on zetomipzomib, a first-in-class, selective immunoproteasome inhibitor. Updates include topline and Phase 2a data from the PORTOLA trial in autoimmune hepatitis, regulatory developments such as the lifting of a partial clinical hold and subsequent FDA feedback on future trial requirements, and presentations of efficacy and biomarker data at major medical meetings. The company has also reported safety and preliminary efficacy findings from the PALIZADE Phase 2b trial in lupus nephritis.
Investors and observers will find earnings and financial results releases that detail research and development spending, general and administrative expenses, restructuring and impairment charges, and reported net losses typical of a clinical-stage enterprise. Kezar’s announcements also describe its strategic review process, workforce reduction and cost-containment measures, repayment and termination of a loan agreement, and the adoption and extension of a shareholder rights plan.
By reviewing KZR news, readers can track clinical milestones, regulatory interactions with the U.S. Food and Drug Administration, participation in healthcare investment conferences, and governance developments such as annual meeting outcomes. This context helps frame how clinical data, capital allocation and strategic alternatives may influence the company’s trajectory. Bookmark this page to follow ongoing disclosures and historical updates related to Kezar Life Sciences.
Kezar Life Sciences (Nasdaq:KZR) announced the FDA Division of Hepatology and Nutrition granted a Type C meeting in Q1 2026 to discuss development of zetomipzomib, a selective immunoproteasome inhibitor, for autoimmune hepatitis (AIH).
Kezar submitted pharmacokinetic and hepatic safety analyses from prior trials to support a proposed global randomized Phase 2b study and parallel AIH and hepatic impairment assessments, plus additional safety data and an updated risk‑mitigation plan intended to address the prior 48‑hour in‑unit monitoring requirement. The company also noted retention of TD Cowen for a strategic review that included workforce reductions and cost‑conservation measures.
Kezar Life Sciences (Nasdaq: KZR) reported Q3 2025 results and strategic actions after failing to align with the FDA on a potential registrational zetomipzomib trial in relapsed/refractory autoimmune hepatitis.
Key items: $90.2M cash and marketable securities at Sept 30, 2025 (down from $132.2M at Dec 31, 2024); initiated a strategic review and retained TD Cowen; repaid $6.3M of Oxford Finance debt on Oct 20, 2025; implemented a restructuring on Nov 6, 2025 reducing headcount by ~70% and estimating ~$6.0M of one-time cash costs, mostly in Q4 2025.
Kezar (Nasdaq: KZR) announced presentations of Phase 2 PORTOLA data in autoimmune hepatitis (AIH) at AASLD The Liver Meeting® 2025 (Nov 7-11, Washington, DC) and Phase 2b PALIZADE data in lupus nephritis at ASN Kidney Week (Nov 5-9, Houston, TX).
Key PORTOLA findings (oral Nov 10, 2025): 36% of steroid-dependent AIH patients on zetomipzomib reached biochemical remission and tapered steroids to ≤5 mg/day versus 0% on placebo; no responders flared during treatment; zetomipzomib was generally well tolerated with mainly mild–moderate injection site reactions. PALIZADE highlights (oral Nov 7, 2025): zetomipzomib 60 mg produced 42% of patients with UPCR ≤0.5 at Week 25 vs 21% placebo and a 64% reduction in SLEDAI-2K from baseline at Week 25.
Kezar Life Sciences (Nasdaq: KZR) announced it is exploring strategic alternatives and retained TD Cowen to support the review while implementing a restructuring and workforce reduction. The FDA canceled a planned Type C meeting about a potential registrational zetomipzomib study in autoimmune hepatitis (AIH) and requested a stand-alone hepatic impairment pharmacokinetic study that would delay AIH trials by ~2 years. The FDA also requires 48-hour in‑unit monitoring for future zetomipzomib trials. Kezar reported ~$90.2M in cash, cash equivalents and marketable securities as of September 30, 2025. Final PORTOLA data will be presented on November 10, 2025 at The Liver Meeting.
Kezar Life Sciences (Nasdaq: KZR), a clinical-stage biotech company focused on immune-mediated disease therapeutics, has announced its participation in two major investor conferences in September 2025.
CEO and Co-founder Chris Kirk will attend the 2025 Wells Fargo Healthcare Conference in Boston on September 5 for a fireside chat, and the H.C. Wainwright 27th Annual Global Investment Conference in New York on September 8 for a pre-recorded presentation. The Wells Fargo conference presentation will be available via webcast on the company's website and archived for 90 days.
Kezar Life Sciences (Nasdaq: KZR) reported key developments in Q2 2025, highlighting progress with its lead drug candidate zetomipzomib. The FDA removed the partial clinical hold on the PORTOLA Phase 2a trial for autoimmune hepatitis (AIH), where the drug showed promising results with 36% of treated patients achieving complete biochemical response versus 0% in placebo group.
The company's financial position shows $100.8 million in cash and equivalents as of June 30, 2025, down from $132.2 million at end-2024. Q2 2025 net loss improved to $13.7 million ($1.87 per share) compared to $21.5 million in Q2 2024, with reduced R&D expenses of $9.6 million and G&A expenses of $5.0 million.
Kezar has submitted a Type C meeting request with the FDA for Q4 2025 to discuss zetomipzomib's development plan in AIH, and the PORTOLA data has been selected for oral presentation at The Liver Meeting® 2025.
Kezar Life Sciences (Nasdaq: KZR) announced that the FDA has lifted the partial clinical hold on its completed PORTOLA Phase 2a trial of zetomipzomib for autoimmune hepatitis (AIH). The decision follows the FDA's review of a comprehensive safety assessment of the zetomipzomib program.
While development in lupus nephritis (LN) remains suspended, Kezar has received recommendations from the Independent Data Monitoring Committee (IDMC) regarding future LN clinical trials. The company plans to request the FDA lift the clinical hold for zetomipzomib in LN based on these recommendations and internal safety data analysis.
Kezar Life Sciences (KZR) announced positive topline results from the PORTOLA Phase 2a trial evaluating zetomipzomib for autoimmune hepatitis (AIH) treatment. In the trial's key findings, 36% of zetomipzomib-treated patients achieved complete biochemical response with significant steroid reduction, compared to 0% in the placebo group.
The study demonstrated that in the intention-to-treat population, 31% of zetomipzomib patients achieved complete response and steroid taper, versus one placebo patient. Notably, the median response duration was 27.6 weeks, with no disease flares reported in responding patients.
Financial highlights as of December 31, 2024:
- Cash position: $132.2 million
- R&D expenses decreased to $65.7 million from $85.7 million in 2023
- G&A expenses reduced to $23.4 million from $26.5 million in 2023
- Net loss: $83.7 million ($11.49 per share)
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