Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
14/09/2026
AbelZeta’s C-CAR168 received FDA IND clearance for PMS. (Ref)
The US FDA cleared AbelZeta Pharma’s Investigational New Drug (IND) application for a Phase 1b/2 trial of C-CAR168 (an anti-CD20/BCMA bispecific CAR-T), in patients with progressive multiple sclerosis (PMS) refractory to standard therapy.
The clearance expanded C-CAR168’s development into refractory chronic autoimmune neurological disease, following recent US FDA RMAT clearance for a registrational Phase 2 trial and EMA CHMP PRIME designation, both in refractory SLE including lupus nephritis.
Takeda’s zasocitinib won US FDA priority review in PsO. (Ref)
The US FDA accepted Takeda Pharmaceuticals' New Drug Application (NDA) under Priority Review for zasocitinib (TAK-279; TYK2 inhibitor) for the treatment of adults with moderate-to-severe plaque psoriasis (PsO).
Acceptance was based on the Phase 3, LATITUDE PsO 3001/ NCT06088043 and LATITUDE PsO 3002/NCT06108544 trials, with supportive data from LATITUDE PsO 3003/ NCT06550076 trial.
The Prescription Drug User Fee Act (PDUFA) target action date is Q1’27 .
