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

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

19/05/2026 UCB announced week 16 data from the BE BOLD study in PsA Zenas BioPharma announced the upcoming presentation of results from the Phase 3 trial of Obexelimab in IgG4-RD at EULAR 2026 Congress Savara presented long-term data from the Phase 3 OLE study of molgramostim inhalation solution in aPAP Tiziana announced positive data for intranasal foralumab in non-active secondary progressive multiple sclerosis ImmuneOnco announced first patient dosed in Phase 2 trial of mo

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

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

21/04/2026 FDA accepted application for Roche’s Gazyva for the treatment of SLE Cristcot announced FDA acceptance of NDA for ngHCA for treatment of UC of the Rectum AstraZeneca announced Phase 3 results for ravulizumab for IgA Nephropathy FDA accepted application for Roche’s Gazyva for the treatment of SLE ( Ref ) Roche announced that the US FDA had accepted a supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab; anti-CD20) for the treatment o

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

30/03/2026 Aurinia Pharmaceuticals announced acquisition of Kezar Life Sciences Savara announced EMA validation of MAA for MOLBREEVI in autoimmune PAP Aurinia Pharmaceuticals announced acquisition of Kezar Life Sciences ( Ref ) Aurinia Pharmaceuticals entered into a definitive merger agreement to acquire Kezar life sciences for $6.955 per share in cash, plus one non-transferable Contingent Value Right (CVR), which represents the right to receive: Potential payments from the

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