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Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
27/07/2026 Argenx to acquire Forte Biosciences and adding FB102 to its Immunology pipeline InnoCare's fadeucravacitinib met it primary endpoint in Phase 3 Psoriasis study Jacobio dosed the first patient in China in Phase 2a trial of JAB-8263 for Rheumatoid arthritis Bambusa Therapeutics reported preliminary Proof-of-concept data for BTT001 in Atopic Dermatitis Argenx to acquire Forte Biosciences and adding FB102 to its Immunology pipeline (Ref) Argenx announced that the compa
decodeMR Team
Jul 273 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
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
decodeMR Team
Jul 212 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
09/07/2026 LEO Pharma announced Phase 2 results of tralokinumab in children with moderate-to-severe atopic dermatitis Fate Therapeutics received FDA clearance of its IND Application for FT839 in autoimmune LEO Pharma announced Phase 2 results of tralokinumab in children with moderate-to-severe atopic dermatitis (Ref) LEO Pharma announced positive results from the Phase 2, TRAPEDS-1 trial evaluated tralokinumab (Anti-IL-13) in children aged 6 to 11 years with moderate-to-sever
decodeMR Team
Jul 101 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
25/06/2026 Kymera Therapeutics completed enrollment in the Phase 2b trial of KT-621 in Atopic Dermatitis Tiziana announced that the last patient was dosed in its Phase 2 trial for the treatment of na-SPMS Leads Biolabs announced that its partner Oblenio Bio had closed a $62 million oversubscribed Series B financing to advance LBL-051 for autoimmune diseases into clinical development Kymera Therapeutics completed enrollment in the Phase 2b trial of KT-621 in Atopic Dermatitis
decodeMR Team
Jun 262 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
17/06/2026 UCB completed acquisition of Candid Therapeutics strengthening next generation immunology pipeline Biogen expanded immunology pipeline with agreement to acquire RayThera UCB completed acquisition of Candid Therapeutics strengthening next generation immunology pipeline (Ref) UCB announced the successful completion of its previously announced acquisition of Candid Therapeutics, a clinical-stage biotechnology company developing novel T-cell engager therapies for autoi
decodeMR Team
Jun 192 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
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
decodeMR Team
Jun 81 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
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
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
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
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
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
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
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
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
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
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
decodeMR Team
Apr 292 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
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
decodeMR Team
Apr 222 min read


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


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
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
decodeMR Team
Apr 151 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
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
decodeMR Team
Apr 31 min read
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