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.
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.
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.
Asahi Kasei has started a Phase I clinical trial in Japan for AK1940, a peptide-based investigational compound for autoimmune diseases. The study will assess pharmacokinetics, safety and tolerability in healthy volunteers.
CRISPR Therapeutics reported a $581.6 million net loss in 2025 with revenue of just $3.5 million, while continuing to advance its gene-editing pipeline including the approved CASGEVY therapy and next-generation CAR T cell programs. The company maintains strategic partnerships and expects current funds to support operations for at least 24 months.
Blackstone closed its sixth dedicated life sciences fund at a $6.3 billion hard cap, the largest private fund raised for the sector. The vehicle is nearly 40% larger than its 2020 predecessor and targets late-stage drug assets.
The National Institute of Allergy and Infectious Diseases has been instructed to remove "biodefense" and "pandemic preparedness" language from its website, signaling a major shift away from these research priorities. NIH leadership says the institute will now focus on current infectious diseases and basic immunology rather than predicting future threats. Public health experts warn this could leave the U.S. less prepared for future health emergencies.
Kelun-Biotech reported 2025 revenue of RMB2.06 billion with four products now marketed in China. The company's TROP2 ADC received multiple regulatory approvals for breast and lung cancer indications. A Phase 3 trial combining the ADC with pembrolizumab met its primary endpoint in first-line NSCLC treatment.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07604792 |
FIT-(BCMA+CD19)-CAR-T Cells in Recurrent/Refractory Autoimmune Diseases Patients. |
ENROLLING_BY_INVITATION | 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 |
Cluster of Differentiation 19 (CD19)/B Cell Maturation Antigen (BCMA) Chimeric Antigen Receptor T-Cell (CAR-T) Therapy for Refractory Autoimmune Diseases |
NOT_YET_RECRUITING | NA |
| NCT07455578 |
Study of S-4321 in Participants With an Autoimmune or Immune-mediated Disease |
NOT_YET_RECRUITING | PHASE1 |
| NCT07408336 |
Clinical Study of AFN50 Injection in the Autoimmune Diseases |
RECRUITING | EARLY_PHASE1 |
| NCT07391046 |
Integrating Vaccination Into Hospital Care Pathways for Vulnerable Patients |
NOT_YET_RECRUITING | |
| NCT07388212 |
Exploratory Study on LNP-mRNA Drugs Targeting CD19/BCMA for the Treatment of Relapsed and Refractory Autoimmune Diseases |
NOT_YET_RECRUITING | EARLY_PHASE1 |
| NCT07363954 |
To Evaluate the Safety and Tolerability of STR-P004 for the Treatment of Immune-mediated Kidney Diseases |
NOT_YET_RECRUITING | NA |
