Zetomipzomib

Plus, news about Praxis, Lexeo Therapeutics and Atai Life Sciences: 🔭 Kezar Life Sciences looks for strategic alternatives: The decision comes after the company said it was “unable to align” with the FDA on a registrational study for zetomipzomib in relapsed and refractory autoimmune hepatitis (AIH), adding that the agency canceled its previously scheduled type C meeting set for the fourth quarter. According to Kezar, the FDA said it should run a stand-alone pharmacokinetics trial in patients with significant hepatic impairment, in addition to another AIH trial. The biotech said that the additional investigation would delay zetomipzomib trials in AIH by about two years. William Blair analysts said they were “surprised” by the update, considering the FDA lifted the partial hold on the drug in July. Kezar’s stock $KZR was up 40% at market open. — Reynald Castaneda 🧳 Taysha regains full rights to Rett syndrome program: The company said its agreement with Astellas from 2022 for the gene therapy has expired. Astellas had the exclusive option to negotiate for a license to the asset, codenamed TSHA-102. Taysha reported data from Part A of a Phase 1/2 trial in May and also announced plans for a pivotal study. — Reynald Castaneda 💰 Praxis’ $525M offering: It is selling about 3 million shares at $157.00 apiece. The move comes after the company reported two Phase 3 wins in essential tremor earlier this week. — Reynald Castaneda 💵 Lexeo Therapeutics’ $135M offering: The company announced that it’s selling about 15.6 million shares for $8.00 apiece. It’s also selling roughly 1.2 million shares to Balyasny Asset Management for the same price in a private placement. Earlier this month, Lexeo said it may be able to apply for accelerated approval of its gene therapy for heart muscle disease in people with Friedreich’s ataxia sooner than expected. — Jaimy Lee 💸  Atai Life Sciences targets $130M in stock sale: The company priced the sale of about 23.7 million shares at $5.48 apiece. It also said the FDA had granted breakthrough therapy designation to BPL-003, its experimental psychedelic nasal spray for patients with treatment-resistant depression. — Jaimy Lee

SOUTH SAN FRANCISCO, CA, USA I July 15, 2025 I Kezar Life Sciences, Inc . (Nasdaq: KZR), a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases, today 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). “We are pleased that the FDA has lifted the partial clinical hold on zetomipzomib in AIH after their review of our comprehensive safety assessment of the zetomipzomib program,” said Chris Kirk, PhD, CEO and co-founder of Kezar. “We continue to believe that zetomipzomib has the potential to positively transform the lives of patients living with AIH. We look forward to engaging with the FDA to align on the design of the next clinical trial of zetomipzomib in AIH.” Although Kezar has suspended development of zetomipzomib in lupus nephritis (LN) to focus on AIH, the company met with the Independent Data Monitoring Committee (IDMC) for the previously terminated PALIZADE clinical trial to review the safety profile of zetomipzomib. The IDMC has provided Kezar with recommendations for conducting future clinical trials in LN. Based on this feedback and internal analysis of safety data across all clinical studies involving zetomipzomib, Kezar plans to respond to the FDA Division of Rheumatology and Transplant Medicine with a request to lift the clinical hold on zetomipzomib in LN. About Zetomipzomib Zetomipzomib is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Preclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression. Data generated from completed clinical trials provide evidence that zetomipzomib exhibits a favorable safety and tolerability profile for development in severe, chronic autoimmune diseases. About Autoimmune Hepatitis Autoimmune hepatitis (AIH) is a rare chronic disease in which the immune system attacks the liver and causes inflammation and tissue damage, severely impacting patients’ physical health and quality of life. Lifelong maintenance therapy is required to avoid relapse and burdensome adverse effects. If left untreated, AIH can lead to cirrhosis, liver failure and hepatocellular carcinoma. In the United States, AIH affects approximately 100,000 individuals, with incidence rates increasing. The cause of this condition remains unclear, with females affected four times as often as males. Currently, standard of care treatment for AIH is chronic, immunosuppressive treatment with corticosteroids that frequently cause life-altering side effects, including diabetes, osteoporotic fractures and cataracts. There is a significant need for treatment regimens that reduce or remove the need for chronic immunosuppression from use of corticosteroids. About Kezar Life Sciences Kezar Life Sciences is a clinical-stage biopharmaceutical company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases. Zetomipzomib, a selective immunoproteasome inhibitor, is currently being evaluated for autoimmune hepatitis. This product candidate also has the potential to address multiple chronic immune-mediated diseases. For more information, visit www.kezarlifesciences.com , and follow us on LinkedIn , Facebook , Twitter and Instagram . SOURCE: Kezar Life Sciences