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Autoimmune-Summaries: Daily Autoimmune Updates at a Glance

decodeMR Team
4 hours ago
1 min read

13/10/2026









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).


  • The registrational Ph 2b, SAFEGUARD study is expected to completed enrolment in Q4’26, with topline data anticipated in 2H’27.











Legacy Healthcare received US FDA Breakthrough Therapy Designation for CINAINU® (LH-8) in alopecia areata (Ref)


Legacy Healthcare’s CINAINU® (LH-8) received US FDA Breakthrough Therapy Designation for moderate-to-severe alopecia areata in adults, adolescents and children aged ≥2 years.


  • The designation was supported by the Ph2/3, RAAINBOW trial in children and adolescents aged 2–17 years.











Evergreen Therapeutics received FDA Fast Track Designation for EG-501 in NPSLE-CI (Ref)


Evergreen Therapeutics’ EG-501received US FDA Fast Track Designation for the treatment of cognitive impairment in adult patients with neuropsychiatric systemic lupus erythematosus (NPSLE-CI).


  • The designation was supported by positive data from the Ph2, ClearMEMory study which demonstrated clinically meaningful improvements in objective neuropsychological function among patients with NPSLE-CI.



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