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Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
14/05/2026 Filing of Gazyva for additional indication of Idiopathic Nephrotic Syndrome Filing of Gazyva for additional indication of Idiopathic Nephrotic Syndrome (Ref) Chugai Pharmaceutical and Nippon Shinyaku announced that Chugai had filed a regulatory application with the Ministry of Health, Labour and Welfare (MHLW) for Gazyva® (obinutuzumab; anti-CD20) for intravenous infusion 1000 mg for an additional indication of idiopathic nephrotic syndrome (INS). The filing was ba
decodeMR Team
5 days ago1 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
07/05/2026 Incyte announced long-term data from Phase 3 study of ruxolitinib cream in adult patients with AD Incyte announced long-term data from Phase 3 study of ruxolitinib cream in adult patients with AD (Ref) Incyte announced final 24-week data from its Phase 3, TRuE-AD4 study which evaluated the efficacy and safety of Opzelura® (ruxolitinib) cream in adults with moderate atopic dermatitis (AD) who had an inadequate response, intolerance or contraindication to topical cor
decodeMR Team
May 81 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
05/05/2026 J&J announced Phase 2b data from two studies in IBD J&J announced Phase 3 results for guselkumab in CD Avalo Therapeutics announced positive Phase 2 results for abdakibart in HS J&J announced Phase 2b data from two studies in IBD (Ref) Johnson & Johnson announced data from two Phase 2b studies, DUET-UC/ NCT05242484 and DUET-CD/ NCT05242471, which evaluated JNJ-4804 (IL-23 and TNF-α) in patients with moderately to severely active ulcerative colitis (UC) and Crohn’s
decodeMR Team
May 62 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
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
decodeMR Team
May 41 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
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
decodeMR Team
Apr 291 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
01/04/2026 Alkermes announced initiation of Phase 3 Brilliance studies evaluating alixorexton for NT1 and NT2 Alkermes announced initiation of Phase 3 Brilliance studies evaluating alixorexton for NT1 and NT2 ( Ref ) Alkermes announced the initiation of the Phase 3 Brilliance studies program, which evaluated the safety and efficacy of alixorexton (ALKS 2680; selective OX2R agonist) for the treatment of adult patients with narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2) T
decodeMR Team
Apr 21 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
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
decodeMR Team
Mar 303 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
16/03/2026 Spyre Therapeutics announced results from the Phase 2 rheumatoid arthritis sub-study InnoCare Pharma announced that ICP-538 had been approved for clinical trials in China and had completed dosing of the first subject Lilly announced Phase 3 results of lebrikizumab in pediatric patients with moderate-to-severe AD Sun Pharma announced US FDA had accepted for review the sBLA for tildrakizumab for the treatment of adults with active PsA Spyre Therapeutics announced res
decodeMR Team
Mar 172 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
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
decodeMR Team
Mar 23 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
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
decodeMR Team
Mar 21 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
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
decodeMR Team
Feb 231 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
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
decodeMR Team
Feb 201 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
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
decodeMR Team
Feb 171 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
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
decodeMR Team
Feb 171 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
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
decodeMR Team
Feb 131 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
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
decodeMR Team
Feb 112 min read
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