09/10/2026 Johnson & Johnson reported 2-year data for icotrokinra in plaque PsO Alumis reported new Phase 3 data for envudeucitinib in plaque PsO Johnson & Johnson reported 2-year data for icotrokinra in plaque PsO (Ref) Johnson & Johnson reported 2-year Phase 3, ICONIC-LEAD/ NCT06095115 data for ICOTYDE® (icotrokinra; IL-23 receptor antagonist) in patients aged ≥12 years with moderate-to-severe plaque psoriasis (PsO).  Endpoint Results Timepoint PASI 90 ≥72% At Wk 12 IGA 0/

02/10/2026 Biogen reported 52-week Phase 2 data for litifilimab in CLE Biogen reported 52-week Phase 2 data for litifilimab in CLE (Ref) Biogen reported 52-week results from the Phase 2 portion (Part A) of the ongoing Phase 2/3 AMETHYST study of litifilimab (BIIB059; anti-BDCA2 mAb) showing continued improvement in cutaneous lupus erythematosus (CLE). 27.2% of patients achieved clear or almost clear skin (CLA-IGA 0–1) at Week 52, while 28.8% achieved CLASI-70. Patients who

30/09/2026 Roche’s fenebrutinib received US FDA filing acceptance for RMS and PPMS Merck’s tulisokibart met primary and key secondary endpoints in Ph2b HS study Roche’s fenebrutinib received US FDA filing acceptance for RMS and PPMS (Ref) The US FDA accepted Roche’s NDA for fenebrutinib (BTKi) under Priority Review for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), supported by Ph3 FENhance 1 and 2 RMS studies and the Ph

25/09/2026 J&J’s guselkumab showed significant improvement in axial PsA FDA approved Lilly's baricitinib for sever AA in paediatric patients aged 12 and older J&J’s guselkumab showed significant improvement in axial PsA (Ref) Johnson & Johnson’s TREMFYA® (guselkumab; anti-IL-23) met its primary and major secondary endpoints in the Phase 4 STAR study in biologic-naïve adults with active psoriatic arthritis and axial involvement (axial PsA). Guselkumab significantly improved sp

24/09/2026 aTyr Pharma aligned with FDA on Phase 3 study of efzifitimod in pulmonary sarcoidosis Kyverna reported 1-year data for miv-cel in SPS and gMG aTyr Pharma aligned with FDA on Phase 3 study of efzifitimod in pulmonary sarcoidosis (Ref) aTyr Pharma reached alignment with the US FDA on the Ph3 protocol for efzofitimod (an immunomodulator) in patients with chronic symptomatic pulmonary sarcoidosis with restrictive lung disease. The company will initially focus on regula

23/09/2026 Roche’s sefaxersen significantly reduced proteinuria in IgA nephropathy Immunovant’s IMVT-1402 failed to meet the primary endpoint in CLE Roche’s sefaxersen significantly reduced proteinuria in IgA nephropathy (Ref) Roche reported positive prespecified interim results from Ph3 IMAgINATION study of sefaxersen (ASO targeting complement factor B) in adults with primary IgA nephropathy (IgAN). The trial met its primary endpoint, demonstrating statistically significant

22/09/2026 Amgen reported positive Phase 3 results for dazodalibep in moderate-to-severe systemic sjögren's disease AbbVie’s RINVOQ® received EU approval for children with active pJIA Amgen reported positive Phase 3 results for dazodalibep in moderate-to-severe systemic sjögren's disease (Ref) Amgen’s Ph3 OASIZ 301 trial of dazodalibep (CD40L antagonist) met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement in systemic disease

18/09/2026 CHMP recommended EU approval of Roche’s Ocrevus for children and adolescents with RMS Novartis’ Cosentyx® received a positive CHMP opinion for PMR Klygefa recommended for EU approval for gMG Alfasigma’s filgotinib received a positive CHMP opinion for axSpA CHMP recommended EU approval of Roche’s Ocrevus for children and adolescents with RMS (Ref) The EMA’s CHMP recommended approval of Ocrevus® (ocrelizumab; CD20 inhibitor) intravenous infusion for patients aged ≥10

16/09/2026 Sling therapeutics dosed the first patient in the Phase 3 trial of linsitinib for TED. Sling therapeutics dosed the first patient in the Phase 3 trial of linsitinib for TED. (Ref) First patient was dosed in Sling Therapeutics’ Phase 3, ORBIT/ NCT07753603 trial evaluating linsitinib (an insulin-like growth factor-1 receptor inhibitor) in adult with moderate to severe active thyroid eye disease (TED). The trial is expected to enroll ~ 130 participants, with the propo

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

10/09/2026 US FDA granted Priority Review to Roche’s Enspryng for MOGAD US FDA granted Priority Review to Roche’s Enspryng for MOGAD. (Ref) Roche announced that the US FDA had granted Priority Review to a supplemental Biologics License Application (sBLA) for Enspryng® (satralizumab; anti- IL-6) for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). The filing acceptance was based on positive results from the Phase 3, METEOROID study, whi

09/09/2026 UCB received US FDA BTD for CIMZIA in pregnant women with antiphospholipid syndrome. Beeline Medicines announced topline results from the Phase 2 study of afimetoran in SLE. UCB received US FDA BTD for CIMZIA in pregnant women with antiphospholipid syndrome. (Ref) UCB announced that the US FDA had granted Breakthrough Therapy Designation (BTD) to CIMZIA® (certolizumab pegol) for the prevention of placenta-mediated adverse pregnancy outcomes in addition to standard

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.

03/09/2026 FDA granted Fast Track Designation to YUTREPIA® for the treatment of Raynaud's phenomenon associated with systemic sclerosis. FDA granted Fast Track Designation to YUTREPIA® for the treatment of Raynaud's phenomenon associated with systemic sclerosis. (Ref) Liquidia Corporation announced that the US FDA had granted Fast Track designation to YUTREPIA® (treprostinil) inhalation powder for the treatment of Raynaud's phenomenon associated with systemic sclerosis (SSc-R

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.

31/08/2026 Lilly to acquire Merida Biosciences to advance treatments for serious autoimmune and allergic diseases Lilly announced 1-year Ph3b data on ixekizumab and tirzepatide used together in adults with psoriatic disease and obesity Lilly to acquire Merida Biosciences to advance treatments for serious autoimmune and allergic diseases (Ref) Eli Lilly and Company and Merida Biosciences announced a definitive agreement for Lilly to acquire Merida Biosciences, a biotechnology

27/08/2026 AbbVie submitted a regulatory application to the EMA for SC induction dosing of risankizumab in adults with moderately to severely active CD TEZSPIRE® demonstrated positive phase 3 results in eosinophilic esophagitis across both co-primary and all key secondary endpoints Argenx completed the acquisition of Forte Biosciences Priovant announced the US FDA approval of brepocitinib for adults with dermatomyositis AbbVie submitted a regulatory application to the EMA for

25/08/2026 Spyre Therapeutics announced topline results from the RA Sub-study of the Phase 2 SKYWAY trial of SPY072 Spyre Therapeutics announced topline results from the RA Sub-study of the Phase 2 SKYWAY trial of SPY072 (Ref) Spyre Therapeutics announced topline results from the rheumatoid arthritis (RA) sub-study of its Phase 2, SKYWAY-RD/ NCT07148414 basket trial evaluating SPY072 (Anti-TL1A) in rheumatic diseases. Both the doses of SPY072 demonstrated statistically signif

24/08/2026 Johnson & Johnson received FDA approval for nipocalimab for the treatment of warm autoimmune hemolytic anemia US FDA granted Orphan Drug Designation to gamgertamig for the treatment of pemphigus Johnson & Johnson received FDA approval for nipocalimab for the treatment of warm autoimmune hemolytic anemia (Ref) Johnson & Johnson announced that the US FDA approved IMAAVY® (nipocalimab-aahu; FcRn blocker) for adults and paediatric patients 12 years of age and older wit

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