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Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
04/06/2026 Gilead Sciences and Lakefront completed the acquisition of Ouro Medicines to further expand inflammation pipeline Gilead Sciences and Lakefront completed the acquisition of Ouro Medicines to further expand inflammation pipeline (Ref) Gilead Sciences and Lakefront Biotherapeutics announced the successful completion of the previously announced acquisition of Ouro Medicines to advance T cell engager therapies for autoimmune diseases. The acquisition added gamgertamig
decodeMR Team
Jun 51 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
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
decodeMR Team
Jun 43 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
02/06/2026 Gilead announced positive phase 3 results for Seladelpar in PBC Vera Therapeutics announced US FDA alignment on an earlier ORIGIN phase 3 eGFR analysis to support potential full approval for atacicept in adults with IgA Nephropathy Rise Therapeutics announced completion of enrollment in the 4-Week dose expansion cohort for R-2487 in RA clinical trial Gilead announced positive phase 3 results for Seladelpar in PBC (Ref) Gilead Sciences announced positive results fro
decodeMR Team
Jun 32 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
01/06/2026 Vertex announced US FDA acceptance of BLA for accelerated approval of Povetacicept in IgA nephropathy Abivax announced Phase 3 maintenance results for obefazimod in moderately to severely active UC Vertex announced US FDA acceptance of BLA for accelerated approval of Povetacicept in IgA nephropathy (Ref) Vertex Pharmaceuticals announced that the US FDA had accepted its Biologics License Application (BLA) submission for povetacicept (anti-BAFF and APRIL) in adults w
decodeMR Team
Jun 21 min read


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


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
27/05/2026 TG Therapeutics announced positive topline results from Phase 3 trial in adults with relapsing form of multiple sclerosis TG Therapeutics announced positive topline results from Phase 3 trial in adults with relapsing form of multiple sclerosis (Ref) TG Therapeutics announced positive topline results from the Phase 3, ENHANCE trial of BRIUMVI® (ublituximab-xiiy; anti-CD20) in adults with relapsing form of multiple sclerosis (RMS). The trial met its primary endpoint,
decodeMR Team
Jun 21 min read


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


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
20/05/2026 Savara presented biomarker data from the Phase 3 trial of molgramostim inhalation solution in aPAP at the ATS International Conference 2026 Savara presented biomarker data from the Phase 3 trial of molgramostim inhalation solution in aPAP at the ATS International Conference 2026 (Ref) Savara presented a poster at American Thoracic Society (ATS) International Conference 2026. The poster reported new biomarker data from the Phase 3, IMPALA-2, double blind study which
decodeMR Team
May 211 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
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
decodeMR Team
May 193 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
18/05/2026 FDA approved IMMGOLIS™ and IMMGOLIS INTRI™ biosimilars for RA and UC FDA approved IMMGOLIS™ and IMMGOLIS INTRI™ biosimilars for RA and UC (Ref) Accord Biopharma announced that the US FDA had approved IMMGOLIS™ (golimumab-sldi) and IMMGOLIS INTRI™ (golimumab-sldi) biosimilar for rheumatoid arthritis (RA) and ulcerative colitis (UC). IMMGOLIS™ (golimumab-sldi), a biosimilar to Simponi® (golimumab), was approved for the treatment of adult patients with moderately to s
decodeMR Team
May 191 min read


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
May 151 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
13/05/2026 Qureight to support Mediar Therapeutics’ Phase 2 trial of MTX-474 in diffuse cutaneous Systemic Sclerosis Qureight to support Mediar Therapeutics’ Phase 2 trial of MTX-474 in diffuse cutaneous Systemic Sclerosis (Ref) Qureight, an imaging CRO and Mediar Therapeutics announced that Qureight’s AI-powered 3D quantitative imaging analytics platform and services will be used to support Mediar’s Phase 2, EncompaSSc trial evaluating MTX-474 (a first in class human mAb, th
decodeMR Team
May 151 min read


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


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
10/05/2026 MoonLake Immunotherapeutics announced a positive outcome from its final Pre-BLA meeting with the US FDA for sonelukimab in HS MoonLake Immunotherapeutics announced a positive outcome from its final Pre-BLA meeting with the US FDA for sonelukimab in HS (Ref) MoonLake Immunotherapeutics announced a positive outcome from its final pre-BLA meeting with the US FDA on the Hidradenitis suppurativa (HS) program for its Nanobody® sonelokimab (SLK; an inhibitor of IL-17A and
decodeMR Team
May 111 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
08/05/2026 BMS received EU approval of deucravacitinib for the treatment of active PsA in adults Argenx announced US approval expanding VYVGART and VYVGART Hytrulo for use in all adult patinets living with gMG BMS received EU approval of deucravacitinib for the treatment of active PsA in adults (Ref) BMS announced that the European Commission had granted approval to Sotyktu (deucravacitinib; TYK2 inhibitor), alone or in combination with methotrexate, for the treatment of acti
decodeMR Team
May 112 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
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
decodeMR Team
May 72 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
04/05/2026 Mirum Pharmaceuticals’ Volixibat met its primary endpoint in a Phase 2b study in Patients with PSC Mirum Pharmaceuticals’ Volixibat met its primary endpoint in a Phase 2b study in Patients with PSC (Ref) Mirum Pharmaceuticals announced that the primary endpoint was met in the Phase 2b, VISTAS study, which evaluated volixibat (an IBAT inhibitor) in patients with primary sclerosong cholangitis (PSC). Volixibat demonstrated a statistically significant and clinically m
decodeMR Team
May 51 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
03/05/2026 UCB announced agreement to acquire Candid Therapeutics, building upon its existing immunology pipeline with novel T-cell engagers UCB announced agreement to acquire Candid Therapeutics, building upon its existing immunology pipeline with novel T-cell engagers (Ref) UCB announced that it had signed a definitive agreement to acquire Candid Therapeutics, a privately held clinical-stage biotechnology company developing novel T-cell engagers for the treatment of autoimm
decodeMR Team
May 41 min read
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