Alleging “untrue statements” included in the approval application for vasculitis drug Tavneos (avacopan), the U.S. FDA’s Center for Drug Evaluation and Research is proposing to withdraw the NDA for small-molecule C5aR antagonist at the center of Amgen Inc.’s 2022 buyout of Chemocentryx Inc. for $3.7 billion.
Pilatus Bio Inc. is working to address a major under-addressed target of current checkpoint inhibitors: metabolic stress within solid tumors. “Traditional immunotherapies release immune ‘brakes,’ but they do not address the underlying metabolic stress in tumors,” Pilatus CEO and cofounder Raven Lin said. “That’s why more than 60% of solid tumor patients do not respond to treatment.”
CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) is awarding US$2.6 million to Adjane Holding BV to advance the development of a vaccine candidate to prevent infections caused by Neisseria gonorrhoeae.
The undrugged transcription factor interferon regulatory factor 5 (IRF5) is involved in autoimmune disorders such as Sjogren’s disease and rheumatoid arthritis in which dysregulation of IRF5 leads to autoantibody formation and secretion of pro-inflammatory cytokines, with type I interferon exacerbating inflammation. Totus Medicines Inc. has presented preclinical data regarding a novel IRF5 inhibitor for controlling autoimmune disorders.
Anaptysbio Inc. announced in September of 2025 that it planned to separate its drug development business from the royalties it receives on Jemperli (dostarlimab) from GSK plc and imsidolimab from Vanda Pharmaceuticals Inc. Just seven months later, on April 20, 2026, well ahead of its “year-end 2026” goal, First Tracks Biotherapeutics Inc., the drug development arm of the company, started trading as a standalone company on Nasdaq under the ticker symbol TRAX.
Four months after receiving a complete response letter from the U.S. FDA for tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis, Sanofi SA received a positive opinion recommending approval in the EU.
Optimism rose for what could be the first CAR T therapy in autoimmune disease as Kyverna Therapeutics Inc. made public a positive primary analysis from its registrational trial, KYSA-8, of mivocabtagene autoleucel (miv-cel, KYV-101) in stiff-person syndrome. Kyverna plans to submit a BLA to the U.S. FDA in the first half of this year.
Researchers from Elpiscience Biopharmaceuticals Inc. hypothesized that dual targeting of the TL1A/DR3 and IL-23 signaling pathways with a single bispecific antibody would exert superior efficacy by reshaping the immune landscape in disorders such as inflammatory bowel disease (IBD). The company has developed a bispecific antibody targeting both TL1A/DR3 and IL-23p19 – ES-302 – for the treatment of IBD.
“Single drugs targeting single biological pathways are insufficient for complex diseases,” Remedy Cell Ltd. CEO Ayelet Dilion Mashiah told BioWorld. Remedy is taking a secretome-based approach to treat lung disorders, having moved its lead asset, RC-0315, into a first-in-human clinical trial for idiopathic pulmonary fibrosis (IPF) in January.
Biogen Inc. has consolidated full global rights to felzartamab through an $850 million deal with TJ Biopharma Co. Ltd. April 20, closing the chapter on a complex 10-year license saga.
RSS
