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

31/08/2026 Lilly to acquire Merida Biosciences to advance treatments for serious autoimmune and allergic diseases Lilly announced 1-year Ph3b data on ixekizumab and tirzepatide used together in adults with psoriatic disease and obesity Lilly to acquire Merida Biosciences to advance treatments for serious autoimmune and allergic diseases (Ref) Eli Lilly and Company and Merida Biosciences announced a definitive agreement for Lilly to acquire Merida Biosciences, a biotechnology

27/08/2026 AbbVie submitted a regulatory application to the EMA for SC induction dosing of risankizumab in adults with moderately to severely active CD TEZSPIRE® demonstrated positive phase 3 results in eosinophilic esophagitis across both co-primary and all key secondary endpoints Argenx completed the acquisition of Forte Biosciences Priovant announced the US FDA approval of brepocitinib for adults with dermatomyositis AbbVie submitted a regulatory application to the EMA for

27/07/2026 Argenx to acquire Forte Biosciences and adding FB102 to its Immunology pipeline InnoCare's fadeucravacitinib met it primary endpoint in Phase 3 Psoriasis study Jacobio dosed the first patient in China in Phase 2a trial of JAB-8263 for Rheumatoid arthritis Bambusa Therapeutics reported preliminary Proof-of-concept data for BTT001 in Atopic Dermatitis Argenx to acquire Forte Biosciences and adding FB102 to its Immunology pipeline (Ref) Argenx announced that the compa

20/07/2026 AbelZeta received EMA PRIME designation for C-CAR168 in LN and SLE LAPIX Therapeutics completed patient enrollment in the RA arm of the ongoing LPX-TI641 clinical trial Almirall announced EMA acceptance of the pediatric filing for Ebglyss® in atopic dermatitis AbelZeta received EMA PRIME designation for C-CAR168 in LN and SLE (Ref) AbelZeta Pharma announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had granted

09/07/2026 LEO Pharma announced Phase 2 results of tralokinumab in children with moderate-to-severe atopic dermatitis Fate Therapeutics received FDA clearance of its IND Application for FT839 in autoimmune LEO Pharma announced Phase 2 results of tralokinumab in children with moderate-to-severe atopic dermatitis (Ref) LEO Pharma announced positive results from the Phase 2, TRAPEDS-1 trial evaluated tralokinumab (Anti-IL-13) in children aged 6 to 11 years with moderate-to-sever

25/06/2026 Kymera Therapeutics completed enrollment in the Phase 2b trial of KT-621 in Atopic Dermatitis Tiziana announced that the last patient was dosed in its Phase 2 trial for the treatment of na-SPMS Leads Biolabs announced that its partner Oblenio Bio had closed a $62 million oversubscribed Series B financing to advance LBL-051 for autoimmune diseases into clinical development Kymera Therapeutics completed enrollment in the Phase 2b trial of KT-621 in Atopic Dermatitis

17/06/2026 UCB completed acquisition of Candid Therapeutics strengthening next generation immunology pipeline Biogen expanded immunology pipeline with agreement to acquire RayThera UCB completed acquisition of Candid Therapeutics strengthening next generation immunology pipeline (Ref) UCB announced the successful completion of its previously announced acquisition of Candid Therapeutics, a clinical-stage biotechnology company developing novel T-cell engager therapies for autoi

06/06/2026 Cullinan Therapeutics presented initial clinical data for CLN-978 at the EULAR-2026 congress Cullinan Therapeutics presented initial clinical data for CLN-978 at the EULAR-2026 congress (Ref) Cullinan Therapeutics announced that it would present initial clinical data from two ongoing Phase 1 studies of CLN-978 (CD19xCD3 T cell engager) at the EULAR-2026 congress. Clinical activity and biomarker findings in OUTRACE SLE Among 14 patients with ≥4 weeks follow up, a ≥4

05/06/2026 Otsuka presented interim Phase 3 data showing sibeprenlimab preserved kidney function over 12 months in IgAN InnoCare presented Phase 2b results for Orelabrutinib in patients with SLE at EULAR-2026 Otsuka presented interim Phase 3 data showing sibeprenlimab preserved kidney function over 12 months in IgAN (Ref) Otsuka Pharmaceutical announced that VOYXACT® (sibeprenlimab-szsi; APRIL inhibitor) preserved kidney function compared to placebo over 12 months in adults w

03/06/2026 Johnson & Johnson late-breaking results showed nipocalimab significantly reduced SLE disease activity in a Phase 2 study Johnson & Johnson announced biomarker exploratory analyses from a Phase 2 study of nipocalimab in moderate-to-severe SjD Argenx presented efgartigimod data showing long-term sustained patient benefit in myositis and SjD at EULAR-2026 JJP Biologics announces positive interim Phase 1b data for nebaprubart in Linear IgA Disease Spyre Therapeutics an

28/05/2026 Zenas BioPharma announced submission of BLA to US FDA for Obexelimab in IgG4-RD Innocare announced the acceptance of the NDA for Orelabrutinib in Primary ITP in China Zenas BioPharma announced submission of BLA to US FDA for Obexelimab in IgG4-RD (Ref) Zenas BioPharma announced the submission of its Biologics License Application (BLA) to the US FDA for obexelimab (CD19 and FcγRIIb) in Immunoglobulin G4-Related Disease (IgG4-RD). The BLA submission was supported by

26/05/2026 Jade Biosciences announced first participant dosed in Phase 2 trial of JADE101 in IgA Nephropathy Jade Biosciences announced first participant dosed in Phase 1 trial of JADE201 in Rheumatoid Arthritis Jade Biosciences announced first participant dosed in Phase 2 trial of JADE101 in IgA Nephropathy (Ref) Jade Biosciences announced that the first participant had been dosed in the Phase 2, JUNIPER/ NCT07541287, trial which evaluated JADE101(Anti-APRIL) in participants

11/05/2026 Fate Therapeutics showcased FT819 clinical activity in SLE without the use of conditioning chemotherapy at the 2026 ASGCT Annual Meeting Fate Therapeutics showcased FT819 clinical activity in SLE without the use of conditioning chemotherapy at the 2026 ASGCT Annual Meeting (Ref) Fate Therapeutics showcased FT819 (an Off-the-shelf CD19 CAR T-cell therapy) which was being investigated in a Phase 1/ NCT06308978 study in patients with moderate-to-severe systemic lupu

06/05/2026 InflaRx announced advancement of Izicopan in AAV and select renal diseases SynAct Pharma completed dosing for the last patient in Phase 2b study for RA InflaRx announced advancement of Izicopan in AAV and select renal diseases (Ref) InflaRx announced that it intended to develop izicopan (an oral C5a receptor inhibitor) in ANCA-Associated Vasculitis (AAV). InflaRx was conducting Phase 2 planning for izicopan in AAV and was evaluating the feasibility of multiple deve

30/04/2026 Merck announced first patient dosed in Phase 3 study with enpatoran for lupus patients with active skin manifestations Merck announced first patient dosed in Phase 3 study with enpatoran for lupus patients with active skin manifestations (Ref) Merck announced that the first patient had been dosed in the Phase 3 program, ELOWEN-1/ NCT07332481and ELOWEN-2/ NCT07355218, evaluating enpatoran (TLR 7/8 inhibitor) in people living with lupus who experience active skin man

29/04/2026 Hutchmed announced NDA acceptance in China with Priority Review status and Breakthrough Designation for sovleplenib for the treatment of wAIHA Hutchmed announced NDA acceptance in China with Priority Review status and Breakthrough Designation for sovleplenib for the treatment of wAIHA (Ref) Hutchmed announced that the New Drug Application (NDA) for sovleplenib (a spleen tyrosine kinase) for the treatment of adult patients with warm antibody autoimmune hemolytic ane

28/04/2026 AbbVie submitted an application to the FDA for upadacitinib for adults and adolescents with Severe AA InnuCare announced that the first patient had been dosed in a Phase 3 trial of orelabrutinib for SLE AbbVie submitted an application to the FDA for upadacitinib for adults and adolescents with Severe AA (Ref) AbbVie announced that it had submitted an application to the US FDA for RINVOQ® (upadacitinib; JAK inhibitor) for the treatment of adult and adolescent patien

27/04/2026 AbbiVe submitted a regulatory application to the FDA for risankizumab for adults with moderately to severely active CD Saphnelo was approved in the US for subcutaneous self-administration for the treatment of SLE Novartis announced that remibrutinib had received EU approval for the treatment of chronic spontaneous urticaria The FDA granted Priority Review for nipocalimab for the treatment of wAIHA AbbiVe submitted a regulatory application to the FDA for risankizuma

22/04/2026 Roche announced Phase 3 data for fenebrutinib in RMS Johnson & Johnson announced Phase 3 data for nipocalimab in gMG Sanofi's Tzield approved in the US to delay the onset of stage 3 T1D in young children Roche announced Phase 3 data for fenebrutinib in RMS (Ref) Roche announced new positive data from the Phase 3 FENhance 1 and 2 studies, Which investigated fenebrutinib (BTK inhibitor) for the treatment of patients with Relapsing Multiple Sclerosis (RMS). FENhance 1