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Autoimmune-Summaries: Daily Autoimmune Updates at a Glance

  • decodeMR Team
  • 4 days ago
  • 3 min read

03/03/2026





























UCB and Antengene entered into a global license agreement for ATG-201 targeting B cell-related autoimmune diseases (Ref)


UCB and Antengene announced they had entered into a global license agreement for ATG-201 (CD19/CD3 bispecific T-cell engager antibody), targeting B cell-related autoimmune diseases


  • The agreement granted UCB worldwide exclusive rights to develop, manufacture, and commercialize ATG-201, including access to its manufacturing technology


  • Antengene planned to submit clinical trial applications for ATG‑201 in China and Australia in the Q1 2026


  • Antengene was set to receive USD 80 million upfront and could earn up to USD 1.1 billion in milestones, plus tiered royalties on future sales




























Johnson & Johnson received US FDA fast track designation for nipocalimab in SLE (Ref)


Johnson & Johnson announced that the US FDA had granted fast track designation to Imaavy (nipocalimab; FcRn blocker) as a potential treatment for adults with systemic lupus erythematosus (SLE)


  • The designation was supported by the Phase 2b, JASMINE/ NCT04882878 study in which nipocalimab demonstrated a reduction in lupus disease activity and the potential for steroid sparing


  • The company had initiated patient enrollment for Phase 3, GARDENIA/ NCT07438496 study in adults with active SLE

























Priovant’s brepocitinib received US FDA acceptance and priority review for patients with dermatomyositis (Ref)


Priovant Therapeutics announced that the US FDA had accepted its New Drug Application (NDA) and had granted the application priority review for brepocitinib (dual inhibitor of TYK2 & JAK1) for the treatment of patients with dermatomyositis (DM)


  • The priority review was supported by the positive Phase 3 VALOR/ NCT05437263 study that evaluated brepocitinib in DM


  • The FDA had assigned a Prescription Drug User Fee Act (PDUFA) target action date in Q3 2026 with launch expected at the end of September 2026





























COUR Pharma announced Phase 2a results of CNP-104 in PBC (Ref)


COUR Pharma announced positive one-year results from its Phase 2a/ NCT05104853 study evaluating CNP-104 for the treatment of patients with Primary Biliary Cholangitis (PBC)


  • CNP-104 improved key cholestasis endpoints at one year, including a composite serum alkaline phosphatasecand bilirubin biochemical response


  • Durable effects were observed across liver stiffness, prognostic risk markers, and liver function following only two doses of CNP-104 administered one week apart


  • Detailed one-year results from the Phase 2a study were expected to be submitted for presentation at a future scientific conference





























Kyowa Kirin announced the discontinuation of rocatinlimab clinical trials (Ref)


Kyowa Kirin announced the discontinuation of all ongoing clinical trials for rocatinlimab (anti-OX40) which were being evaluated for potential indications in moderate-to-severe atopic dermatitis (AD), moderate-to-severe asthma, and prurigo nodularis


  • Kyowa Kirin and Amgen concluded that the risks of the rocatinlimab clinical program outweighed its benefits following a recent safety review


  • The review had identified emerging viral or immune-related malignancy concerns, specifically pointing to recent and previously confirmed cases of Kaposi’s sarcoma


  • Both companies notified clinical trial investigators and regulatory authorities and stated that after trial participants completed the required safety follow-up visits, all studies would be formally terminated




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