Novartis Presents 31 Immunology Abstracts at EULAR 2026 Spanning Biologics and CAR-T Modalities

Scaling a portfolio that spans small molecules, biologics, and autologous CAR-T within a single regulatory and manufacturing framework is among the more demanding operational challenges in modern pharma, and Novartis is presenting data at EULAR 2026 (June 3–6, London) that will sharpen scrutiny on exactly that challenge across 31 accepted abstracts.

The highest-profile disclosure is the Phase III REPLENISH trial readout for Cosentyx (secukinumab) in polymyalgia rheumatica, described as the largest global Phase III trial conducted in that indication. An oral session on June 3 will present Week 52 results, with a companion poster covering subgroup analyses. For QA and regulatory leads tracking biologic label expansions, REPLENISH data will inform CMC expectations and post-approval commitments in a patient population with distinct immunological profiles from secukinumab's established indications.

The more operationally complex disclosures centre on rap-cel (rapcabtagene autoleucel, YTB323), Novartis's autologous CD19-directed CAR-T candidate. Preliminary data from the open-label AUTOGRAPH-IIM and AUTOGRAPH-SSC studies in severe refractory idiopathic inflammatory myopathies and diffuse cutaneous systemic sclerosis will be presented in an oral session June 3. A separate poster on June 5 will cover up to 24-month clinical, cellular kinetics, pharmacodynamics, and biomarker data in severe refractory systemic lupus erythematosus. Autologous CAR-T manufacturing operates under distinct GMP requirements, chain-of-identity controls, patient-specific batch release, and cryopreservation logistics, that differ materially from conventional biologic fill-finish. As rap-cel data accumulate across multiple autoimmune indications, manufacturing scalability and comparability between production runs will attract regulatory attention ahead of any BLA or MAA submission.

Ianalumab, a BAFF-receptor-targeting monoclonal antibody, contributes two oral presentations. Interim results from the NEPTUNUS-1 and NEPTUNUS-2 Phase III extension study in Sjögren's disease, covering data to Week 108, will be presented June 3. End-of-study Phase II results in systemic lupus erythematosus follow on June 5. For process validation teams, long-duration extension studies generate stability and comparability datasets that directly inform ICH Q10 lifecycle management planning for the drug substance and drug product.

Taken together, the 31 abstracts represent a cross-modality data package that will inform regulatory strategy, manufacturing scale-up decisions, and supply-chain architecture for multiple programs simultaneously, a coordination burden that plant heads and regulatory affairs leads at Novartis and its contract partners will need to manage in parallel with ongoing commercial operations.

The REPLENISH Phase III oral presentation on June 3 at 4:30 pm BST is the near-term checkpoint most likely to trigger downstream CMC and labeling activity.

Source: Novartis via GlobeNewswire, June 1, 2026.