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

10/03/2026 Redx’s RXC008 granted US FDA fast track designation for fibrostenotic CD Redx’s RXC008 granted US FDA fast track designation for fibrostenotic CD ( Ref ) Redx Pharma announced that the US FDA had granted fast track designation to RXC008 (a GI-restricted pan-ROCK inhibitor) for the treatment of patients with fibrostenotic crohn’s disease (CD) Lisa Anson, CEO, Redx Pharma: “ Redx have been working closely with the FDA and the STAR consortium to define the regulatory

09/03/2026 Pfizer announced Phase 2 results of tilrekimig in AD Vertex announced Phase 3 results of Povetacicept in IgA Nephropathy Pfizer announced Phase 2 results of tilrekimig in AD ( Ref ) Pfizer announced positive topline results from its Phase 2 study that evaluated tilrekimig (PF-07275315; trispecific antibody targets Il-4, IL-13 and TSLP) for the treatment of adult patients with moderate to severe atopic dermatitis (AD) The study met its primary endpoint, demonstratin

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

03/03/2026 UCB and Antengene entered into a global license agreement for ATG-201 targeting B cell-related autoimmune diseases Johnson & Johnson received US FDA fast track designation for nipocalimab in SLE Priovant’s brepocitinib received US FDA acceptance and priority review for patients with dermatomyositis COUR Pharma announced Phase 2a results of CNP-104 in PBC Kyowa Kirin announced the discontinuation of rocatinlimab clinical trials UCB and Antengene entered into a globa

02/03/2026 Lynk Pharmaceuticals announced positive Phase 3 data for zemprocitinib in moderate-to-severe atopic dermatitis Abbive announced topline results form a Phase 3 study that evaluated resankizumab subcutaneous induction in patients with CD Roche announced positive results from a Phase 3 study that evaluated fenebrutinib in patients with RMS Sanofi's rilzabrutinib earned orphan drug designation in Japan for IgG4-related disease Lynk Pharmaceuticals announced positive Ph

27/02/2026 Lilly's Olumiant recommended by CHMP for approval of expanded use in the European Union for adolescents with severe alopecia areata Lilly's Olumiant recommended by CHMP for approval of expanded use in the European Union for adolescents with severe alopecia areata ( Ref ) Eli Lilly and Company and Incyte announced European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion for Olumiant (baricitinib; JAK inhib

26/02/2026 GSK’s linerixibat accepted for Priority review by China’s NMPA in patients with PBC Boehringer acquired an exclusive license for a novel oral therapeutics program for immune diseases from Sitryx Argenx announced topline results from Phase 3 trial of VYVGART in Ocular myasthenia gravis Soligenix received a positive opinion from the EMA on its request for orphan drug designation for SGX945 for the treatment of behçet's disease GSK’s linerixibat accepted for Priority

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

21/02/2026 Three-year data demonstrated sustained clinical and endoscopic remission in ulcerative colitis with guselkumab Three-year data demonstrated sustained clinical and endoscopic remission in ulcerative colitis with guselkumab ( Ref ) Johnson & Johnson announced new long-term data from the Phase 2b/3 QUASAR/ NCT04033445 study evaluating TREMFYA® (guselkumab; anti-IL-23) in adult patients with moderately-to-severely active ulcerative colitis (UC) In this study, guselkuma

20/02/2026 Dr. Reddy’s announced that the US FDA had accepted for review its BLA for a proposed interchangeable biosimilar of ORENCIA® Savara announced that the US FDA had filed for review the BLA for MOLBREEVI for the treatment of autoimmune PAP Dr. Reddy’s announced that the US FDA had accepted for review its BLA for a proposed interchangeable biosimilar of ORENCIA® ( Ref ) Dr. Reddy’s Laboratories announced that the US FDA had accepted for review its Biologics License Appl

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

13/02/2026 Novartis announced Phase 3 data in adult patients with IgA nephropathy Novartis announced Phase 3 data in adult patients with IgA nephropathy ( Ref ) Novartis announced final results from its Phase 3 ALIGN/ NCT04573478 study which evaluated Vanrafia (atrasentan; an ETA receptor antagonist) in adult patients with IgA nephropathy (IgAN) The study demonstrated a slowing of kidney function decline in adult patients with IgAN The ALIGN study showed a difference of 2.39

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