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

15/04/2026 Savara announced that the US FDA had extended the review period for molgramostim BLA in autoimmune PAP Savara announced that the US FDA had extended the review period for molgramostim BLA in autoimmune PAP ( Ref ) Savara announced that the FDA had extended the review period for the malgramostim ( Molgramostim Inhalation Solution ) BLA in autoimmune pulmonary alveolar proteinosis (Autoimmune PAP) by three months The Agency was reviewing the molgramostim BLA under Pr

13/04/2026 Saphnelo® subcutaneous approved in Canada for the treatment of SLE Saphnelo® subcutaneous approved in Canada for the treatment of SLE ( Ref ) Astrazeneca announced that Health Canada had granted a Notice of Compliance (NOC) for Saphnelo ® (anifrolumab; type 1 IFNR) for subcutaneous self-administration via a single-use autoinjector in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) in addition to standard therapy The approval by

02/04/2026 Immunovant announced Phase 3 results for batoclimab in thyroid eye disease Immunovant announced Phase 3 results for batoclimab in thyroid eye disease ( Ref ) Immunovant announced topline results from its two Phase 3 (GO) studies that evaluated batoclimab (an FcRn antagonist) for the treatment of adult patients with active, moderate-to-severe thyroid eye disease (TED) The studies failed to meet their primary endpoint of achieving ≥2mm proptosis responder rate at We

28/03/2026 Biogen announced Phase 2 results for litifilimab for CLE Results from Sanofi’s Phase 3 studies in AD were presented AAD Alumis announced Phase 3 data for envudeucitinib for plaque psoriasis Incyte announced Phase 3 data for povorcitinib for HS Biogen announced Phase 2 results for litifilimab for CLE ( Ref ) Biogen announced positive results from part A of its Phase2/3 AMETHYST/ NCT05531565 study, which evaluated litifilimab (BDCA2) for the treatment of patients w

11/03/2026 UCB announced Phase 3 results of bimekizumab versus Risankizumab in a head-to-head study in PsA UCB announced Phase 3 results of bimekizumab versus Risankizumab in a head-to-head study in PsA ( Ref ) UCB announced positive topline results from its Phase 3 BE BOLD/ NCT06624228 head-to-head study, which evaluated BIMZELX®▼(bimekizumab; a selective inhibitor of IL-17A and IL-17F) versus SKYRIZI® (risankizumab; a selective inhibitor of IL-23) for the treatment of adu

06/03/2026 The US FDA approved deucravacitinib for the treatment of patients with active PsA Aisa Pharma announced the results from its Phase 2 trial of AISA-021 in patients with SSc RP The US FDA approved deucravacitinib for the treatment of patients with active PsA ( Ref ) BMS announced that the US FDA had approved Sotyktu® (deucravacitinib; TYK2 inhibitor) for the treatment of adult patients with active psoriatic arthritis (PsA) The approval was based on positive results f

24/02/2026 Abcuro announced topline results from its Phase 2/3 study of ulviprubart in patients with inclusion body myositis J&J submitted sBLA to the US FDA for approval of IMAAVY® for warm autoimmune hemolytic anemia Abcuro announced topline results from its Phase 2/3 study of ulviprubart in patients with inclusion body myositis ( Ref ) Abcuro announced topline results from its Phase 2/3 MUSCLE/ NCT05721573 study, which evaluated ulviprubart (ABC008; anti-KLRG1) for the tre

22/02/2026 MoonLake announced topline results from its Phase 2 study of sonelokimab in axial spondyloarthritis MoonLake announced topline results from its Phase 2 study of sonelokimab in axial spondyloarthritis ( Ref ) MoonLake Immunotherapeutics announced positive topline results from its Phase 2, S-OLARIS study evaluating sonelokimab (IL-17A and IL-17F inhibitor) in patients with radiographic and non-radiographic axial spondyloarthritis The study demonstrated a clinically m

19/02/2026 AstraZeneca’s Saphnero was approved in Japan for patients with Systemic Lupus Erythematosus AstraZeneca’s Saphnero was approved in Japan for patients with Systemic Lupus Erythematosus ( Ref ) AstraZeneca announced that Japan had approved Saphnero (aniflorumab; anti-IFN1R) subcutaneous injection 120 mg autoinjector for the treatment of patients with Systemic Lupus Erythematosus (SLE) This approval by the Ministry of Health, Labour and Welfare was based on the result

17/02/2026 Sanofi and Teva’s duvakitug Phase 2b maintenance data demonstrated clinically meaningful durable efficacy in UC and CD Nektar Therapeutics announced a research collaboration with UCSF and Dr. Stephen Hauser for NKTR-0165 in multiple sclerosis Sanofi and Teva’s duvakitug Phase 2b maintenance data demonstrated clinically meaningful durable efficacy in UC and CD ( Ref ) Sanofi and Teva announced positive results from the Phase 2b RELIEVE UCCD LTE/NCT05668013 study of

16/02/2026 Roche announced positive Phase 3 results for Gazyva/Gazyvaro in primary membranous nephropathy Roche announced positive Phase 3 results for Gazyva/Gazyvaro in primary membranous nephropathy ( Ref ) Roche announced positive results from the Phase 3 MAJESTY/ NCT04629248 study which evaluated the efficacy and safety of Gazyva/Gazyvaro (obinutuzumab; anti-CD20) in patients with primary membranous nephropathy The study met its primary endpoint of complete remission at t

12/02/2026 The European Commission approved inebilizumab for the treatment of generalized myasthenia gravis The European Commission approved inebilizumab for the treatment of generalized myasthenia gravis ( Ref ) The European Commission approved Amgen’s Uplizna®(inebilizumab; anti-CD19 mAb) as an add-on treatment to standard therapy for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (M

10/02/2026 US FDA accepted NDA and granted priority review for Takeda’s oveporexton as a potential first-in-class therapy for Narcolepsy Type 1 Evommune reported positive top-line data from Phase 2a POC trial of EVO301 in moderate-to-severe atopic dermatitis Kincell Bio partnered with Regcell to advance Treg cell therapies into clinical trials for autoimmune diseases US FDA accepted NDA and granted priority review for Takeda’s oveporexton as a potential first-in-class therapy