CRISPR Therapeutics said CASGEVY launch momentum is building and multiple pipeline assets could generate data in the next 12 to 18 months. The company also highlighted zugo-cel progress in oncology and autoimmune disease.
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.
Sift Biosciences closed an oversubscribed $3.7 million pre-seed round to advance a peptide immunotherapy platform designed to activate pre-existing memory T cells. The financing will fund in vivo studies, expansion of its AI-powered discovery engine, and oncology lead selection.
CRISPR Therapeutics reported a Q4 2025 loss of $1.37 per share, missing estimates, with revenues of $0.9 million falling short of expectations. The company's partner Vertex recorded $54 million in Casgevy sales for the quarter, with regulatory submissions for pediatric label expansion planned for early 2026.
Autolus Therapeutics reported $74.3 million in 2025 revenue during its first commercial year, while facing a -265% gross margin. The company aims to achieve positive margins by 2026 through scaling production and expanding into autoimmune diseases with promising early lupus trial results. The broader CAR-T therapy market is projected to reach $9.85 billion in the US by 2033.
Research reveals how ectopic NMDA receptor expression in triple-negative breast cancer triggers autoimmune disease through antibody maturation. The study shows NMDAR expression recruits B cells and drives affinity maturation, producing antibodies that can cross the blood-brain barrier and cause neurological symptoms while constraining tumor growth.
Monash University and Ono Pharmaceutical have signed two licence agreements for the development of anti-GPCR antibodies targeting autoimmune and inflammatory diseases. The agreements result from Ono exercising options on research collaborations announced in 2023. The partnership combines Monash's research excellence with Ono's drug development capabilities to address unmet medical needs.
The immuno-oncology market is projected to grow from $65.22 billion in 2025 to $170.19 billion by 2032, driven by checkpoint inhibitors, CAR-T cell therapy, and cancer vaccines, with North America commanding 43% market share.
Eli Lilly announced the acquisition of Orna Therapeutics for up to $2.4 billion on February 9, 2026, gaining access to proprietary circular RNA technology and an "in vivo" CAR-T platform for immunology and oncology applications.
The global stem cell therapy market is projected to grow from $18.13 billion in 2025 to $59.70 billion by 2035 at a 12.66% CAGR, driven by chronic disease prevalence and regenerative medicine advances.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07523282 |
Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases |
NOT_YET_RECRUITING | PHASE1 |
| NCT07366866 |
A Study of Safety, Tolerability, PK, and PD of Subcutaneous GenSci136 in Healthy Adults. |
RECRUITING | PHASE1 |
| NCT06993493 |
Autologous CD19CAR-T Therapy for Recurrent/Refractory Autoimmune Diseases |
RECRUITING | NA |
| NCT06983964 |
Safety and Efficacy of CD19 CAR-T Therapy for Recurrent/Refractory Autoimmune Diseases |
RECRUITING | NA |
| NCT06827457 |
A Study of Safety, Tolerability, PK, and PD of Subcutaneous GenSci120 in Healthy Adults. |
COMPLETED | PHASE1 |
| NCT06817889 |
Remdesivir for the Treatment of Upper Respiratory Tract Infection Due to RSV in Immunocompromised Individuals |
RECRUITING | PHASE2 |
| NCT06633042 |
The Safety and Efficacy of Universal CAR-T Cells Targeting BCMA in the Treatment of Refractory NMOSD |
NOT_YET_RECRUITING | PHASE1 |
| NCT06488209 |
Single and Multiple Ascending Dose Study in Healthy Participants and Participants With an Autoimmune Disease |
COMPLETED | PHASE1 |
| NCT06004349 |
Autoimmune and Autoinflammatory Genetics Study |
RECRUITING | |
| NCT05894707 |
Evaluate the Safety and Tolerability of SCT650C in Healthy Volunteers |
UNKNOWN | PHASE1 |
