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Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
06/07/2026 Aurinia announced the initiation of a Phase 4 study investigating the combination of voclosporin and belimumab, obinutuzumab or anifrolumab in patients with LN Aurinia announced the initiation of a Phase 4 study investigating the combination of voclosporin and belimumab, obinutuzumab or anifrolumab in patients with LN (Ref) Aurinia Pharmaceuticals announced the initiation of the Phase 4, PRESERVE/ NCT07611214 study investigating the combination of LUPKYNIS® (voclos
decodeMR Team
8 hours ago1 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
01/07/2026 Ostuka reported positive Phase 3 results for sibeprenlimab in IgAN Ostuka reported positive Phase 3 results for sibeprenlimab in IgAN (Ref) Otsuka Pharmaceutical announced positive topline full study results from the Phase 3, VISIONARY/ NCT05248646 trial for VOYXACT® (sibeprenlimab-szsi; Anti-APRIL) in adults with primary IgA nephropathy (IgAN) at risk of disease progression. Sibeprenlimab demonstrated statistically significant stabilization of eGFR with evidence
decodeMR Team
8 hours ago1 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
30/06/2026 FDA granted priority review to Roche’s satralizumab as a treatment option for TED FDA granted priority review to Roche’s satralizumab as a treatment option for TED (Ref) Roche announced that the US FDA had accepted and granted priority review to a supplemental Biologics License Application (sBLA) for Enspryng® (satralizumab) for the treatment of thyroid eye disease (TED). The filing acceptance was based on results from the two randomized phase 3, SatraGO-1/ NCT0598
decodeMR Team
Jun 301 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
29/06/2026 Abbvie received positive CHMP opinion for upadacitinib for the treatment of adults and adolescents with Non-segmental Vitiligo Abbvie received positive CHMP opinion for upadacitinib for the treatment of adults and adolescents with severe alopecia areata Zura Bio exceeded Phase 2 enrollment target for HS and SSc and expanded tibulizumab program Dianthus Therapeutics announced the initiation of a Phase 3 trial of claseprubart in gMG Abivax announced ABETACT maintenan
decodeMR Team
Jun 303 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
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
23/06/2026 Sanofi’s Wayrilz approved in Japan to treat immune thrombocytopenia Sanofi’s tolebrutinib approved in the EU for secondary progressive multiple sclerosis without relapses Abbive announced EC approval of risankizumab for the treatment of pediatric patients with oderate to severe plaque psoriasis Sanofi’s Wayrilz approved in Japan to treat immune thrombocytopenia (Ref) Sanofi announced that the Ministry of Health, Labour and Welfare in Japan had granted marketing and
decodeMR Team
Jun 242 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
22/06/2026 Merck’s tulisokibart met primary and key secondary endpoints in a Phase 3 study in patiets with moderately to severely active UC FDA and EMA accepted cemdisiran regulatory submissions for review for the treatment of gMG Prolium Biosciences announced milestones in systemic sclerosis and refractory lupus nephritis Merck’s tulisokibart met primary and key secondary endpoints in a Phase 3 study in patiets with moderately to severely active UC (Ref) Merck announced posi
decodeMR Team
Jun 242 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
21/06/2026 MoonLake Immunotherapeutics announced Phase 3 results for sonelokimab in Hidradenitis Suppurativa MoonLake Immunotherapeutics announced Phase 3 results for sonelokimab in Hidradenitis Suppurativa (Ref) MoonLake Immunotherapeutics announced the week 52 results from its Phase 3, VELA-1 and VELA-2 trials of sonelokimab (SLK; IL-17 A/F inhibitor) for the treatment of patients with moderate-to-severe Hidradenitis Suppurativa (HS). At week 52, sonelokimab showed consiste
decodeMR Team
Jun 241 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
18/06/2026 GRI Bio secured FDA Orphan Drug Designation for Tazarotene in Idiopathic Pulmonary Fibrosis GRI Bio secured FDA Orphan Drug Designation for Tazarotene in Idiopathic Pulmonary Fibrosis (Ref) GRI Bio announced that the US FDA had granted Orphan Drug Designation to Tazarotene (GRI-062; oral RARβ/γ-selective agonist) for the treatment of Idiopathic Pulmonary Fibrosis (IPF). The designation marked a significant regulatory milestone and provided a potential pathway to se
decodeMR Team
Jun 191 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
16/06/2026 Avalo Therapeutics added AVTX-010, a long-acting next-generation anti-IL-1β antibody, to Its development pipeline Avalo Therapeutics added AVTX-010, a long-acting next-generation anti-IL-1β antibody, to Its development pipeline (Ref) Avalo Therapeutics announced the advancement of AVTX-010 (anti-IL-1β mAb) with the potential for development in hidradenitis suppurativa (HS) as well as additional inflammatory disorders. The Company expected to submit an Investigation
decodeMR Team
Jun 181 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
15/06/2026 SynAct Pharma reported Phase 2b data of resomelagon in Rheumatoid Arthritis Ultomiris granted Priority Review in the US as treatment for adults with immunoglobulin A nephropathy XBiotech launched Phase 2 trial evaluating vilamakitug for the treatment of active axial spondyloarthritis Spyre announced Part A results from Phase 2 trial of SPY002 in moderate-to-severe UC SynAct Pharma reported Phase 2b data of resomelagon in Rheumatoid Arthritis (Ref) SynAct Pharma AB
decodeMR Team
Jun 152 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
12/06/2026 Sanofi’s Tzield approved in the US for patients recently diagnosed with stage 3 T1D Sanofi’s Tzield approved in the US for patients recently diagnosed with stage 3 T1D (Ref) Sanofi announced that the US FDA had granted accelerated approval to Tzield (teplizumab-mzwv; CD30directed mAb) to delay the decline in endogenous (own) insulin production in children aged eight to 17 years recently diagnosed with stage 3 T1D. The approval was supported by the Phase 3, PROTECT/
decodeMR Team
Jun 151 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
11/06/2026 Nipocalimab demonstrated a durable hemoglobin response and rapid onset of effect in a Phase 2/3 study in wAIHA Climb Bio announced initial Phase 1b data for budoprutug in ITP at EHA Congress 2026 Takeda’s Zasocitinib significantly outperformed deucravacitinib in a head-to-head Phase 3 Psoriasis Study Nipocalimab demonstrated a durable hemoglobin response and rapid onset of effect in a Phase 2/3 study in wAIHA (Ref) Johnson & Johnson presented results from the Phase
decodeMR Team
Jun 122 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
10/06/2026 Sanofi provided update on the phase 3 study of riliprubart in chronic inflammatory demyelinating polyneuropathy Sanofi provided update on the phase 3 study of riliprubart in chronic inflammatory demyelinating polyneuropathy (Ref) Sanofi announced that the Phase 3, MOBILIZE/ NCT06290128 study of riliprubart (SAR445088, BIVV020; IgG4 mAb), in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) refractory to standard-of-care treatment would be stopp
decodeMR Team
Jun 111 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
09/06/2026 US FDA approved a new every-eight week maintaince dosing option for Lilly’s lebrikizumab in moderate-to-severe atopic dermatitis US FDA accepted Takeda's application for Intravenous vedolizumab in Pediatric UC and CD US FDA approved a new every-eight week maintaince dosing option for Lilly’s lebrikizumab in moderate-to-severe atopic dermatitis (Ref) Eli lilly announced that the US FDA approved a regimen of one maintenance dose every eight weeks of a single injectio
decodeMR Team
Jun 112 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
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
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