South Korea’s Ministry of Food and Drug Safety (MFDS) approved Curocell Inc.’s Limcato (anbalcabtagene-autoleucel; anbal-cel) April 29 as the first homegrown CAR T-cell therapy to treat patients with advanced diffuse large B-cell lymphomas.
Riltide Medicines Co. Ltd. has identified new cyclic GMP-AMP synthase (MB21D1; cGAS) inhibitors potentially useful for the treatment of autoimmune disease, rheumatic disease, cardiovascular, dermatological, renal, respiratory, neurological and inflammatory disorders, among others.
The combination of impaired epithelial barrier function, mucosal inflammation and elevated oxidative stress is determinant for the pathogenesis of ulcerative colitis (UC). NF-E2-related factor 2 (NRF2) is an important transcription factor for modulating antioxidant defenses, inhibiting inflammatory pathways and regenerating the epithelial barrier. Montai Therapeutics Inc. has developed a potent and selective NRF2 agonist compound, MTAI-1025, for the management of UC using its proprietary CONECTA platform.
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.
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