13/10/2026 SAB BIO received US FDA Fast Track Designation for SAB-142 in stage 3 T1D Legacy Healthcare received US FDA Breakthrough Therapy Designation for CINAINU® (LH-8) in alopecia areata Evergreen Therapeutics received FDA Fast Track Designation for EG-501 in NPSLE-CI SAB BIO received US FDA Fast Track Designation for SAB-142 in stage 3 T1D (Ref) SAB Biotherapeutics’ SAB-142 received US FDA Fast Track Designation for treatment of new-onset Stage 3 Type 1 diabetes (T1D). T

09/09/2026 UCB received US FDA BTD for CIMZIA in pregnant women with antiphospholipid syndrome. Beeline Medicines announced topline results from the Phase 2 study of afimetoran in SLE. UCB received US FDA BTD for CIMZIA in pregnant women with antiphospholipid syndrome. (Ref) UCB announced that the US FDA had granted Breakthrough Therapy Designation (BTD) to CIMZIA® (certolizumab pegol) for the prevention of placenta-mediated adverse pregnancy outcomes in addition to standard