08/07/2026 Merck announced that the US FDA had granted Breakthrough Therapy designation to enpatoran Chemomab Therapeutics and Scipher Medicine announced a merger to advance nebokitug in an AI-powered Phase 2 Rheumatoid Arthritis study Merck announced that the US FDA had granted Breakthrough Therapy designation to enpatoran (Ref) Merck announced that the US FDA had granted Breakthrough Therapy designation to enpatoran (TLR 7/8 inhibitor) for the treatment of lupus with active

07/07/2026 Vera Therapeutics announced US FDA accelerated approval of TRUTAKNA™ for adults with primary IgA nephropathy Turn Therapeutics announced the final stage 2 design and data-driven expansion of the GX-03 phase 2 trial in Atopic Dermatitis Everest Medicines announced the closing of its exclusive licencing agreement with Travere Therapeutics for civorebrutinib Vera Therapeutics announced US FDA accelerated approval of TRUTAKNA™ for adults with primary IgA nephropathy (R

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

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

02/06/2026 Gilead announced positive phase 3 results for Seladelpar in PBC Vera Therapeutics announced US FDA alignment on an earlier ORIGIN phase 3 eGFR analysis to support potential full approval for atacicept in adults with IgA Nephropathy Rise Therapeutics announced completion of enrollment in the 4-Week dose expansion cohort for R-2487 in RA clinical trial Gilead announced positive phase 3 results for Seladelpar in PBC (Ref) Gilead Sciences announced positive results fro

01/06/2026 Vertex announced US FDA acceptance of BLA for accelerated approval of Povetacicept in IgA nephropathy Abivax announced Phase 3 maintenance results for obefazimod in moderately to severely active UC Vertex announced US FDA acceptance of BLA for accelerated approval of Povetacicept in IgA nephropathy (Ref) Vertex Pharmaceuticals announced that the US FDA had accepted its Biologics License Application (BLA) submission for povetacicept (anti-BAFF and APRIL) in adults w

28/05/2026 Zenas BioPharma announced submission of BLA to US FDA for Obexelimab in IgG4-RD Innocare announced the acceptance of the NDA for Orelabrutinib in Primary ITP in China Zenas BioPharma announced submission of BLA to US FDA for Obexelimab in IgG4-RD (Ref) Zenas BioPharma announced the submission of its Biologics License Application (BLA) to the US FDA for obexelimab (CD19 and FcγRIIb) in Immunoglobulin G4-Related Disease (IgG4-RD). The BLA submission was supported by

26/05/2026 Jade Biosciences announced first participant dosed in Phase 2 trial of JADE101 in IgA Nephropathy Jade Biosciences announced first participant dosed in Phase 1 trial of JADE201 in Rheumatoid Arthritis Jade Biosciences announced first participant dosed in Phase 2 trial of JADE101 in IgA Nephropathy (Ref) Jade Biosciences announced that the first participant had been dosed in the Phase 2, JUNIPER/ NCT07541287, trial which evaluated JADE101(Anti-APRIL) in participants

06/05/2026 InflaRx announced advancement of Izicopan in AAV and select renal diseases SynAct Pharma completed dosing for the last patient in Phase 2b study for RA InflaRx announced advancement of Izicopan in AAV and select renal diseases (Ref) InflaRx announced that it intended to develop izicopan (an oral C5a receptor inhibitor) in ANCA-Associated Vasculitis (AAV). InflaRx was conducting Phase 2 planning for izicopan in AAV and was evaluating the feasibility of multiple deve

05/05/2026 J&J announced Phase 2b data from two studies in IBD J&J announced Phase 3 results for guselkumab in CD Avalo Therapeutics announced positive Phase 2 results for abdakibart in HS J&J announced Phase 2b data from two studies in IBD (Ref) Johnson & Johnson announced data from two Phase 2b studies, DUET-UC/ NCT05242484 and DUET-CD/ NCT05242471, which evaluated JNJ-4804 (IL-23 and TNF-α) in patients with moderately to severely active ulcerative colitis (UC) and Crohn’s

04/05/2026 Mirum Pharmaceuticals’ Volixibat met its primary endpoint in a Phase 2b study in Patients with PSC Mirum Pharmaceuticals’ Volixibat met its primary endpoint in a Phase 2b study in Patients with PSC (Ref) Mirum Pharmaceuticals announced that the primary endpoint was met in the Phase 2b, VISTAS study, which evaluated volixibat (an IBAT inhibitor) in patients with primary sclerosong cholangitis (PSC). Volixibat demonstrated a statistically significant and clinically m

03/05/2026 UCB announced agreement to acquire Candid Therapeutics, building upon its existing immunology pipeline with novel T-cell engagers UCB announced agreement to acquire Candid Therapeutics, building upon its existing immunology pipeline with novel T-cell engagers (Ref) UCB announced that it had signed a definitive agreement to acquire Candid Therapeutics, a privately held clinical-stage biotechnology company developing novel T-cell engagers for the treatment of autoimm

30/04/2026 Merck announced first patient dosed in Phase 3 study with enpatoran for lupus patients with active skin manifestations Merck announced first patient dosed in Phase 3 study with enpatoran for lupus patients with active skin manifestations (Ref) Merck announced that the first patient had been dosed in the Phase 3 program, ELOWEN-1/ NCT07332481and ELOWEN-2/ NCT07355218, evaluating enpatoran (TLR 7/8 inhibitor) in people living with lupus who experience active skin man

29/04/2026 Hutchmed announced NDA acceptance in China with Priority Review status and Breakthrough Designation for sovleplenib for the treatment of wAIHA Hutchmed announced NDA acceptance in China with Priority Review status and Breakthrough Designation for sovleplenib for the treatment of wAIHA (Ref) Hutchmed announced that the New Drug Application (NDA) for sovleplenib (a spleen tyrosine kinase) for the treatment of adult patients with warm antibody autoimmune hemolytic ane

28/04/2026 AbbVie submitted an application to the FDA for upadacitinib for adults and adolescents with Severe AA InnuCare announced that the first patient had been dosed in a Phase 3 trial of orelabrutinib for SLE AbbVie submitted an application to the FDA for upadacitinib for adults and adolescents with Severe AA (Ref) AbbVie announced that it had submitted an application to the US FDA for RINVOQ® (upadacitinib; JAK inhibitor) for the treatment of adult and adolescent patien

23/04/2026 Cumberland Pharmaceuticals announced strategic transaction to integrate commercial business with Apotex Cumberland Pharmaceuticals announced strategic transaction to integrate commercial business with Apotex (Ref) Cumberland Pharmaceuticals announced it had entered into an agreement with an affiliate of Apotex to integrate their branded US business. Under the terms of the agreement, Apotex was to acquire Cumberland's line of branded pharmaceuticals for cash conside

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

20/04/2026 Nektar Therapeutics announced results from Phase 2b study for rezpegaldesleukin in severe-to-very severe AA Biogen entered into agreement with TJ Biopharma for felzartamab in the Greater China Region Nektar Therapeutics announced results from Phase 2b study for rezpegaldesleukin in severe-to-very severe AA ( Ref ) Nektar Therapeutics announced topline results from its Phase 2b REZOLVE-AA/ NCT06340360 study, which evaluated rezpegaldesleukin (IL-2 pathway agonist) f

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