15/04/2026 Savara announced that the US FDA had extended the review period for molgramostim BLA in autoimmune PAP Savara announced that the US FDA had extended the review period for molgramostim BLA in autoimmune PAP ( Ref ) Savara announced that the FDA had extended the review period for the malgramostim ( Molgramostim Inhalation Solution ) BLA in autoimmune pulmonary alveolar proteinosis (Autoimmune PAP) by three months The Agency was reviewing the molgramostim BLA under Pr

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

02/04/2026 Immunovant announced Phase 3 results for batoclimab in thyroid eye disease Immunovant announced Phase 3 results for batoclimab in thyroid eye disease ( Ref ) Immunovant announced topline results from its two Phase 3 (GO) studies that evaluated batoclimab (an FcRn antagonist) for the treatment of adult patients with active, moderate-to-severe thyroid eye disease (TED) The studies failed to meet their primary endpoint of achieving  ≥2mm proptosis responder rate at We

01/04/2026 Alkermes announced initiation of Phase 3 Brilliance studies evaluating alixorexton for NT1 and NT2 Alkermes announced initiation of Phase 3 Brilliance studies evaluating alixorexton for NT1 and NT2 ( Ref ) Alkermes announced the initiation of the Phase 3 Brilliance studies program, which evaluated  the safety and efficacy of alixorexton (ALKS 2680; selective OX2R agonist) for the treatment of adult patients with narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2) T

31/03/2026 Galapagos and Gilead entered into a binding agreement to collaborate on advancing a T cell engager program for autoimmune diseases Galapagos and Gilead entered into a binding agreement to collaborate on advancing a T cell engager program for autoimmune diseases ( Ref ) Galapagos and Gilead Sciences entered into a binding collaboration agreement to co-develop gamgertamig (OM336; BCMAxCD3 T cell engager) originally developed by Ouro Medicines targeting deep B-cell de

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

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

23/03/2026 Gilead Sciences to acquire Ouro Medicines to advance first in class T cell engager program for autoimmune diseases Apogee Therapeutics announced Phase 2 results of zumilokibart in Moderate-to-Severe AD Galapagos and Gilead in advanced discussions to collaborate on advancing first in class T cell engager program for autoimmune diseases Kali Therapeutics announced a worldwide exclusive license agreement with Sanofi for KT501 for autoimmune diseases Gilead Sciences to

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

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

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

09/03/2026 Pfizer announced Phase 2 results of tilrekimig in AD Vertex announced Phase 3 results of Povetacicept in IgA Nephropathy Pfizer announced Phase 2 results of tilrekimig in AD ( Ref ) Pfizer announced positive topline results from its Phase 2 study that evaluated tilrekimig (PF-07275315; trispecific antibody targets Il-4, IL-13 and TSLP) for the treatment of adult patients with moderate to severe atopic dermatitis (AD) The study met its primary endpoint, demonstratin

06/03/2026 The US FDA approved deucravacitinib for the treatment of patients with active PsA Aisa Pharma announced the results from its Phase 2 trial of AISA-021 in patients with SSc RP The US FDA approved deucravacitinib for the treatment of patients with active PsA ( Ref ) BMS announced that the US FDA had approved Sotyktu® (deucravacitinib; TYK2 inhibitor) for the treatment of adult patients with active psoriatic arthritis (PsA) The approval was based on positive results f

03/03/2026 UCB and Antengene entered into a global license agreement for ATG-201 targeting B cell-related autoimmune diseases Johnson & Johnson received US FDA fast track designation for nipocalimab in SLE Priovant’s brepocitinib received US FDA acceptance and priority review for patients with dermatomyositis COUR Pharma announced Phase 2a results of CNP-104 in PBC Kyowa Kirin announced the discontinuation of rocatinlimab clinical trials UCB and Antengene entered into a globa

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

24/02/2026 Abcuro announced topline results from its Phase 2/3 study of ulviprubart in patients with inclusion body myositis J&J submitted sBLA to the US FDA for approval of IMAAVY® for warm autoimmune hemolytic anemia Abcuro announced topline results from its Phase 2/3 study of ulviprubart in patients with inclusion body myositis ( Ref ) Abcuro announced topline results from its Phase 2/3 MUSCLE/ NCT05721573 study, which evaluated ulviprubart (ABC008; anti-KLRG1) for the tre

22/02/2026 MoonLake announced topline results from its Phase 2 study of sonelokimab in axial spondyloarthritis MoonLake announced topline results from its Phase 2 study of sonelokimab in axial spondyloarthritis ( Ref ) MoonLake Immunotherapeutics announced positive topline results from its Phase 2, S-OLARIS study evaluating sonelokimab (IL-17A and IL-17F inhibitor) in patients with radiographic and non-radiographic axial spondyloarthritis The study demonstrated a clinically m

21/02/2026 Three-year data demonstrated sustained clinical and endoscopic remission in ulcerative colitis with guselkumab Three-year data demonstrated sustained clinical and endoscopic remission in ulcerative colitis with guselkumab ( Ref ) Johnson & Johnson announced new long-term data from the Phase 2b/3 QUASAR/ NCT04033445 study evaluating TREMFYA® (guselkumab; anti-IL-23) in adult patients with moderately-to-severely active ulcerative colitis (UC) In this study, guselkuma

20/02/2026 Dr. Reddy’s announced that the US FDA had accepted for review its BLA for a proposed interchangeable biosimilar of ORENCIA® Savara announced that the US FDA had filed for review the BLA for MOLBREEVI for the treatment of autoimmune PAP Dr. Reddy’s announced that the US FDA had accepted for review its BLA for a proposed interchangeable biosimilar of ORENCIA® ( Ref ) Dr. Reddy’s Laboratories announced that the US FDA had accepted for review its Biologics License Appl

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