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Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
14/09/2026 AbelZeta’s C-CAR168 received FDA IND clearance for PMS Takeda’s zasocitinib won US FDA priority review in PsO. AbelZeta’s C-CAR168 received FDA IND clearance for PMS. (Ref) The US FDA cleared AbelZeta Pharma’s Investigational New Drug (IND) application for a Phase 1b/2 trial of C-CAR168 (an anti-CD20/BCMA bispecific CAR-T), in patients with progressive multiple sclerosis (PMS) refractory to standard therapy. The clearance expanded C-CAR168’s development into refrac
decodeMR Team
3 days ago1 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
08/09/2026 Vor Bio announced the completion of enrollment in its Phase 3 trial of telitacept in gMG Spyre Therapeutics announced Phase 2 Part A induction results for SPY003 in UC Alebund Pharmaceuticals announced FDA clearance of its IND application for AP308 for the treatment of IgA Nephropathy Greywolf Therapeutics dosed the first participant with axSpA in the Ph1/2 trial of GRWD0715. Vor Bio announced the completion of enrollment in its Phase 3 trial of telitacept in gMG.
decodeMR Team
Sep 102 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
01/09/2026 Novartis’s remibrutinib significantly reduced relapse rates and demonstrated a favourable safety profile in Ph3 RMS trials. Adicet Bio announced completion of the last patient visit for the planned analysis of prula-cel study in patients with SLE with or without LN. Alumis announced topline results from the Ph2b trail of envudeucitinib in SLE. Novartis’s remibrutinib significantly reduced relapse rates and demonstrated a favourable safety profile in Ph3 RMS trials.
decodeMR Team
Sep 32 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
18/08/2026 Biocon announced US FDA approval of Yesintek® single dose prefilled autoinjector Abcuro announced a $66 million series D financing to advance ulviprubart in inclusion body myositis Biocon announced US FDA approval of Yesintek® single dose prefilled autoinjector (Ref) Biocon announced that its US Subsidiary had received supplemental US FDA approval for Yesintek® (ustekinumab-kfce) as a single-dose prefilled autoinjector. The approval covered 45 mg/0.5 mL and 90 mg/m
decodeMR Team
Aug 181 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
06/08/2026 Biogen completed the acquisition of RayThera to strengthen its immunology pipeline Ono Pharmaceutical entered into a drug discovery partnership with Mediar Therapeutics to create novel antibody therapeutics for fibro-inflammatory diseases Mediar Therapeutics entered into a collaboration and option agreement with Ono Pharmaceutical Biogen completed the acquisition of RayThera to strengthen its immunology pipeline (Ref) Biogen announced the completion of its acquisit
decodeMR Team
Aug 72 min read


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
13/07/2026 Novartis received Health Canada approval for VANRAFIA™ to reduce proteinuria in adults with primary IgAN IQIRVO® demonstrated statistically significant improvement in ALP normalization in patients with PBC in Phase 3b study Q32 Bio announced results from Part B of the Phase 2a study of bempikibart in Alopecia Areata Novartis received Health Canada approval for VANRAFIA™ to reduce proteinuria in adults with primary IgAN (Ref) Novartis Pharmaceuticals Canada announce
decodeMR Team
Jul 152 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
07/07/2026 Vera Therapeutics announced US FDA accelerated approval of TRUTAKNA™ for adults with primary IgA nephropathy Turn Therapeutics announced the final stage 2 design and data-driven expansion of the GX-03 phase 2 trial in Atopic Dermatitis Everest Medicines announced the closing of its exclusive licencing agreement with Travere Therapeutics for civorebrutinib Vera Therapeutics announced US FDA accelerated approval of TRUTAKNA™ for adults with primary IgA nephropathy (R
decodeMR Team
Jul 82 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
26/06/2026 SKYRIZI® received US FDA approval for pediatric psoriatic disease Viridian Therapeutics announced US FDA approval and commercial launch of Lumvoa™ for Thyroid Eye Disease SKYRIZI® received US FDA approval for pediatric psoriatic disease (Ref) AbbVie announced that the US FDA had approved SKYRIZI® (risankizumab-rzaa; IL-23 inhibitor) for the treatment of children six years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic ther
decodeMR Team
Jun 291 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
08/06/2026 Telitacicept received NMPA conditional approval for the treatment of IgA Nephropathy in China Telitacicept received NMPA approval for the treatment of Sjögren’s disease in China Alvotech announced FDA acceptance of a BLA for AVT16, a proposed interchangeable biosimilar to Entyvio® Telitacicept received NMPA conditional approval for the treatment of IgA Nephropathy in China (Ref) Vor Bio and RemeGen Co. announced that China’s National Medicinal Products Administrati
decodeMR Team
Jun 92 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
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
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
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
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
07/04/2026 Climb Bio announced FDA Fast Track Designation for budoprutug for the treatment of pMN Climb Bio announced FDA Fast Track Designation for budoprutug for the treatment of pMN ( Ref ) Climb Bio announced that the US FDA had granted Fast Track Designation to budoprutug (anti-CD19 mAb) for the treatment of primary membranous nephropathy (pMN) Brudoprutug was being studied in Phase 2 patinets with pMN The company anticipated initial data from Phase 2 study in H2 2026
decodeMR Team
Apr 91 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
06/04/2026 Tenvie Therapeutics announced dosing of first subject in Phase 1 trial of TNV262 Amgen announced topline results from Phase 3 teprotumumab in active TED Tenvie Therapeutics announced dosing of first subject in Phase 1 trial of TNV262 ( Ref ) Tenvie Therapeutics announced the first subject dosed in a Phase 1 clinical study evaluating TNV262 (a fully CNS-penetrant small molecule inhibitor targeting NLRP3) for the treatment of cardiometabolic diseases, including obesi
decodeMR Team
Apr 72 min read
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