Zetomipzomib

DelveInsight's report highlights a robust lupus nephritis pipeline with 30+ companies developing 35+ therapies, including key players like AstraZeneca and Novartis. Promising therapies like Anifrolumab and Ianalumab are in various clinical phases, with recent updates from companies like Adicet Bio and Kyverna Therapeutics. The report provides comprehensive insights into the pipeline, therapeutic assessments, and market dynamics.

Kezar Life Sciences faces a second FDA clinical hold in two months, this time on its PORTOLA study for zetomipzomib in autoimmune hepatitis, following a previous hold on the PALIZADE study for lupus nephritis. The company plans to investigate safety events and report data in 2025.

AstraZeneca to pay $2B to CSPC for a cardiovascular drug, Astellas Pharma licenses gene therapy from AviadoBio, Merck partners with Mestag Therapeutics for fibrosis treatments, Insitro signs three agreements with Eli Lilly for metabolic diseases, MiNK Therapeutics and Autonomous Therapeutics collaborate on metastatic tumors, Bayer and MOMA Therapeutics partner in oncology, Wonderskin names 5W Public Relations as AOR, Eversana signs with Oracle Argus Cloud, Qinotto and Eli Lilly collaborate, Onspire Health acquires Aesthetic Brand Marketing, Reunion Neuroscience partners with Seleni Institute, Danco Laboratories to seek FDA approval for Mifeprex use in miscarriages, Exact Sciences' Cologuard Plus wins FDA approval, Boehringer Ingelheim's survodutide gets Breakthrough Therapy designation, Lunds & Byerlys recalls Lone Star Dip, Kezar Life Sciences' zetomipzomib development halted by FDA, Bayer's elinzanetant NDA accepted by FDA, Biogen's felzartamab gets Breakthrough Therapy Designation, Black Diamond Therapeutics to cut jobs, Upstream Bio targets $182M for IPO, City Therapeutics launches with $135M, Purespring Therapeutics raises $105M, Judo Bio launches with $100M, Orasis Pharmaceuticals raises $78M, CAMP4 Therapeutics targets $67M for IPO, Basecamp Research closes $60M Series B, Arda Therapeutics raises $43M Series A, Crinetics Pharmaceuticals announces public offering, GSK to pay $2.2B to settle Zantac lawsuits, Scholar Rock's SMA drug shows muscle function improvement, CDC to screen travelers due to Marburg virus outbreak in Rwanda, Ad Council, AMA, and CDC launch flu vaccination campaign, Sage Therapeutics' Sage-718 fails in Alzheimer's study, WeightWatchers adds GLP-1 obesity treatments, Gritstone Bio files for Chapter 11, BioPharmCatalyst launches AI-powered chatbot Aiden, Otsuka Precision Health and Amalgam Rx launch Alzheimer's app Elevmi, PatientPoint unveils interactive communication solution, Curia rebrands, Switzerland's COMCO terminates Novartis investigation, Bluebird Bio's Skysona linked to blood cancer in seven children, Solera Health rebrands, HearingLife launches pickleball sweepstakes, Alfasigma launches Morpho brand, Healthy Minds Innovations launches Our World Of Emotions campaign.

FDA placed a clinical hold on Kezar Life Sciences’ zetomipzomib for lupus nephritis after the company voluntarily ended enrollment and dosing in its Phase 2b PALIZADE trial due to serious adverse events, including four deaths.

FDA placed a clinical hold on Kezar Life Sciences' zetomipzomib development for lupus nephritis after 4 patients died in Phase IIb PALIZADE trial. Kezar observed common symptoms and proximity to dosing in the deaths and other serious adverse events, leading to voluntary suspension of enrollment and dosing. The company is investigating potential risk mitigation strategies and expects a formal FDA letter. Kezar continues zetomipzomib development for autoimmune hepatitis unaffected by the hold.

FDA imposes clinical hold on Kezar Life Sciences' zetomipzomib trial for lupus nephritis due to fatal serious adverse events in Phase II PALIZADE trial.

Kezar Life Sciences' zetomipzomib IND for lupus nephritis is on clinical hold due to safety concerns, including four fatal SAEs in the Philippines and Argentina. The company remains committed to patient safety and unaffected by the hold in its autoimmune hepatitis IND.

Johnson & Johnson proposed changes to the 340B drug discount program, but backed down after HRSA deemed them inconsistent with the statute. The 340B program, established in 1992, aims to help underserved communities by allowing eligible hospitals and clinics to purchase outpatient prescription medications at discounts. Recent regulatory developments include FDA approvals for Exact Sciences' Cologuard Plus, Partners Fresenius Kabi and Formycon's Otulfi, Eli Lilly's Retevmo, Sanofi and Regeneron's Dupixent, Bristol Myers Squibb's Cobenfy, and others. Additionally, Pfizer withdrew Oxbryta from the market due to safety concerns.