Autoimmune disease
Kezar Life Sciences suffered multiple clinical holds and four patient deaths in a trial testing zetomipzomib for lupus—a program that has since been canned. The company is still pursuing development in autoimmune hepatitis, but recent FDA communications could delay its timeline.
With a 100% response rate in a Phase II study, KYV-101 sets a new efficacy bar in generalized myasthenia gravis, according to analysts at William Blair.
Phase I/II data for rese-cel point to its therapeutic potential in systemic lupus erythematosus and lupus nephritis, as well as other autoimmune conditions.
Phase III data for dapirolizumab pegol presented at the 2025 conference of the American College of Rheumatology showed quality-of-life benefits in systemic lupus erythematosus that could see Biogen go head-to-head with GSK and AstraZeneca in a blockbuster space.
The anti-CD20 antibody, developed by Roche’s Genentech along with Biogen and already approved for multiple oncology indications, is branching into autoimmune disease. Its B cell–targeting mechanism of action gives it activity in improving kidney conditions in patients with lupus nephritis.
The partners have yet to disclose what their priority indications are, though EVOQ’s NanoDisc technology aims to enable the development of potentially curative treatments for autoimmune conditions such as celiac disease and type 1 diabetes.
While Bruton’s tyrosine kinase inhibitors are often hailed as the next big breakthrough in multiple sclerosis, Immunic Therapeutics and others are leveraging neuroprotective targets and remyelination to keep the disease at bay.
Ocaliva won accelerated approval for primary biliary cholangitis in 2016, which the FDA refused to upgrade to full approval last year after an advisory committee was unable to verify a favorable risk/benefit profile.
The autoimmune and inflammatory disease–focused company canceled plans to go public earlier this year as the IPO window slammed shut.
Health Secretary Robert F. Kennedy Jr. will appear before the Senate Finance Committee Thursday, ahead of a vaccine advisory committee meeting later in September. Meanwhile, deal-making appetite appears healthy, and the weight loss space continues generating clinical data and other news.
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