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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
6 days ago3 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
26/03/2026 UCB received positive CHMP opinion for zilucoplan in EU for adults with gMG Soligenix received orphan drug designation from the European Commission for SGX945 for the treatment of Behçet's Disease UCB received positive CHMP opinion for zilucoplan in EU for adults with gMG ( Ref ) UCB announced that the European Medicines Agency’s CHMP had issued a positive opinion to expand the use of ZILBRYSQ® (zilucoplan; C5 inhibitor), with a new pre-filled pen device as an add
decodeMR Team
Mar 271 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
17/03/2026 Celltrion announced that the tocilizumab SC formulation was now commercially available to patients in the US Celltrion announced that the tocilizumab SC formulation was now commercially available to patients in the US ( Ref ) Celltrion announced that AVTOZMA® (tocilizumab; IL-6 receptor antagonist) subcutaneous (SC) formulation was now commercially available to patients in the United States AVTOZMA® was among the first wave of tocilizumab biosimilars with both intr
decodeMR Team
Mar 171 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
13/03/2026 Novartis announced FDA approval of secukinumab for pediatric patients with moderate to severe HS Novartis announced FDA approval of secukinumab for pediatric patients with moderate to severe HS ( Ref ) Novartis announced that the US FDA had approved Cosentyx® (secukinumab; anti-IL-17A) for the treatment of pediatric patients aged 12 years and older with moderate to severe hidradenitis suppurativa (HS) The use of Cosentyx in patients aged 12 years and older with mod
decodeMR Team
Mar 161 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
11/03/2026 UCB announced Phase 3 results of bimekizumab versus Risankizumab in a head-to-head study in PsA UCB announced Phase 3 results of bimekizumab versus Risankizumab in a head-to-head study in PsA ( Ref ) UCB announced positive topline results from its Phase 3 BE BOLD/ NCT06624228 head-to-head study, which evaluated BIMZELX®▼(bimekizumab; a selective inhibitor of IL-17A and IL-17F) versus SKYRIZI® (risankizumab; a selective inhibitor of IL-23) for the treatment of adu
decodeMR Team
Mar 121 min read


Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
10/03/2026 Redx’s RXC008 granted US FDA fast track designation for fibrostenotic CD Redx’s RXC008 granted US FDA fast track designation for fibrostenotic CD ( Ref ) Redx Pharma announced that the US FDA had granted fast track designation to RXC008 (a GI-restricted pan-ROCK inhibitor) for the treatment of patients with fibrostenotic crohn’s disease (CD) Lisa Anson, CEO, Redx Pharma: “ Redx have been working closely with the FDA and the STAR consortium to define the regulatory
decodeMR Team
Mar 111 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
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