Autoimmune diseases are conditions in which the immune system mistakenly attacks the body's own tissues and organs. They comprise many disorders affecting multiple organ systems.
CAR-T therapy reaches 150 patients in Ireland and expands into autoimmune trials for lupus and MS. Kyverna's miv-cel nears FDA approval for stiff person syndrome, and new research links gene variants to CAR-T outcomes.
Amgen detailed its T-cell engager and precision therapy strategy at Citi's 2026 summit. GT Biopharma, Onco-Innovations, Oncotelic, and Samsung Biologics also advanced AI and organoid platforms in drug development.
Cue Biopharma appointed Dominic Borie as chief medical officer and R&D head as it advances CUE-221 (Phase 2 data expected Q3 2026) and CUE-401 (Phase 1 start Q4 2026). He brings over 20 years of immunology and clinical development experience. The company recently raised $50M to support clinical development.
Colorado's Prescription Drug Affordability Board imposed a price cap on Enbrel, making it the first U.S. state to cap a specific drug's price. Amgen is suing to block the cap, arguing it interferes with federal patent law protections for innovative drugs. The federal court is considering whether to issue a temporary injunction, with a ruling expected soon.
ByteDance is expanding its AI drug-discovery work through Anew Labs and US hiring for its Seed AI team. Anew Labs has presented AI-developed therapies and molecular modeling work at international conferences.
Global biologics market projected to grow to USD 1.28 trillion by 2035; Japan cell and gene therapy market to reach USD 2.15 billion by 2034; Japan biologic drug lifecycle management market to hit USD 9.69 billion by 2033.
The iPSC-derived NK cells pipeline includes 12+ active players and 15+ drugs in development. FT522 is in Phase I, while CNTY-101 and NCR300 are among other programs in the clinic.
Astellas terminated its phase 1 ASP5502 study in Sjögren’s syndrome as Novartis said the FDA granted breakthrough therapy designation to ianalumab. Novartis plans global regulatory submissions from early 2026 after positive phase III data.
Eli Lilly and Company has agreed to acquire Orna Therapeutics for up to $2.4 billion in cash. The deal includes ORN-252, a clinical-trial-ready CD19-targeting in vivo CAR-T therapy for B cell-driven autoimmune diseases.
Kyverna Therapeutics reports positive long-term follow-up results for its CAR-T therapy miv-cel in generalized myasthenia gravis, with plans to submit a biologics license application in the first half of 2026. The company has $279.3 million in cash providing runway into 2028 to fund launch and Phase 3 trials.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07778446 |
A Study to Test CRT-402 in Refractory Autoimmune Disease |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07759115 |
Music-4-MS to Improve Cognition in People Living With Multiple Sclerosis: A Feasibility Study |
RECRUITING | NA |
| NCT07699380 |
METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D) |
RECRUITING | PHASE2 |
| NCT07674147 |
RD06-05 Universal CD19/BCMA CAR-T for Refractory Pediatric Autoimmune Diseases |
NOT_YET_RECRUITING | EARLY_PHASE1 |
| NCT07613411 |
Safety and Efficacy of KSVCBD Injection in Autoimmune Diseases |
NOT_YET_RECRUITING | EARLY_PHASE1 |
| NCT07604792 |
FIT-(BCMA+CD19)-CAR-T Cells in Recurrent/Refractory Autoimmune Diseases Patients. |
SUSPENDED | EARLY_PHASE1 |
| NCT07586267 |
CD19/BCMA UCAR-T for B Cell-Related Autoimmune Disease |
RECRUITING | EARLY_PHASE1 |
| NCT07513181 |
Proof of Concept Study Evaluating the Efficacy and Safety of ATH-063 Treatment in Patients With Relapsed/Refractory Moderately to Severely Active Ulcerative Colitis (UC) |
NOT_YET_RECRUITING | PHASE2 |
| NCT07507201 |
Allogeneic CD19/BCMA CAR-T for B Cell-Related Autoimmune Disease |
RECRUITING | EARLY_PHASE1 |
| NCT07490951 |
A Clinical Study of the Safety, Tolerability and Preliminary Efficacy of CD19/BCMA-targeted CAR-T Therapy in Refractory Autoimmune Diseases |
RECRUITING | NA |
