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

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

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

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.

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

27/05/2026 TG Therapeutics announced positive topline results from Phase 3 trial in adults with relapsing form of multiple sclerosis TG Therapeutics announced positive topline results from Phase 3 trial in adults with relapsing form of multiple sclerosis (Ref) TG Therapeutics announced positive topline results from the Phase 3, ENHANCE trial of BRIUMVI® (ublituximab-xiiy; anti-CD20) in adults with relapsing form of multiple sclerosis (RMS). The trial met its primary endpoint,

19/05/2026 UCB announced week 16 data from the BE BOLD study in PsA Zenas BioPharma announced the upcoming presentation of results from the Phase 3 trial of Obexelimab in IgG4-RD at EULAR 2026 Congress Savara presented long-term data from the Phase 3 OLE study of molgramostim inhalation solution in aPAP Tiziana announced positive data for intranasal foralumab in non-active secondary progressive multiple sclerosis ImmuneOnco announced first patient dosed in Phase 2 trial of mo

24/04/2026 Sanofi’s tolebrutinib was recommended for EU approval to treat secondary progressive multiple sclerosis without relapses Sanofi’s tolebrutinib was recommended for EU approval to treat secondary progressive multiple sclerosis without relapses (Ref) Sanofi announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Cenrifki (tolebrutinib; BTK inhibitor) in the EU for the

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

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

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

02/03/2026 Lynk Pharmaceuticals announced positive Phase 3 data for zemprocitinib in moderate-to-severe atopic dermatitis Abbive announced topline results form a Phase 3 study that evaluated resankizumab subcutaneous induction in patients with CD Roche announced positive results from a Phase 3 study that evaluated fenebrutinib in patients with RMS Sanofi's rilzabrutinib earned orphan drug designation in Japan for IgG4-related disease Lynk Pharmaceuticals announced positive Ph

17/02/2026 Sanofi and Teva’s duvakitug Phase 2b maintenance data demonstrated clinically meaningful durable efficacy in UC and CD Nektar Therapeutics announced a research collaboration with UCSF and Dr. Stephen Hauser for NKTR-0165 in multiple sclerosis Sanofi and Teva’s duvakitug Phase 2b maintenance data demonstrated clinically meaningful durable efficacy in UC and CD ( Ref ) Sanofi and Teva announced positive results from the Phase 2b RELIEVE UCCD LTE/NCT05668013 study of