Amgen(US:AMGN)2026-02-12 23:00Summary of Amgen Conference Call - February 12, 2026 Company Overview - Company: Amgen (NasdaqGS:AMGN) - Focus: Development of innovative therapies for autoimmune diseases and other conditions Key Products and Developments UPLIZNA - Indications: Plans to initiate Phase III studies for autoimmune hepatitis (AIH) and chronic inflammatory demyelinating polyneuropathy (CIDP) later in 2026 - Mechanism: B-cell depleter targeting CD19, effective in conditions driven by pathogenic B-cells - Market Potential: - CIDP prevalent pool in the U.S. estimated at 35,000 patients, with 7,000-10,000 new cases annually - AIH likely has a larger patient population, though exact numbers are difficult to ascertain - Rationale: Proven effectiveness in similar conditions like IgG4-related disease and generalized myasthenia gravis supports the potential for UPLIZNA in AIH and CIDP [1][2][3][4][6] Daxdilimab - Indications: Positive Phase II results in discoid lupus; previously failed in systemic lupus erythematosus (SLE) - Mechanism: Targets immunoglobulin-like transcript seven protein (ILT-7), depleting plasmacytoid dendritic cells involved in interferon production - Clinical Results: - Discoid lupus study met primary endpoint of reduced disease severity at week 24 - Secondary endpoint also showed clinical benefit - Future Plans: Considering Phase III study for discoid lupus, with potential for broader indications in autoimmune diseases driven by plasmacytoid dendritic cells [9][10][11][13][16] Dazodalibep - Indications: Targeting Sjögren's syndrome with two ongoing Phase III studies - Mechanism: Inhibits CD40 ligand, disrupting B-cell activation and downstream inflammatory cascades - Clinical Management: Current management is symptomatic; no definitive treatments exist - Phase II Results: Showed improvement in disease activity index and patient-reported outcomes, providing confidence for Phase III studies [18][26][29][32] TEZSPIRE - Indications: Recently expanded label for chronic rhinosinusitis with nasal polyps - Mechanism: Targets TSLP, addressing upstream drivers of inflammation, differentiating it from therapies targeting downstream cytokines (IL-4, IL-5, IL-13) - Clinical Results: Phase 3 Waypoint study showed significant reduction in nasal polyp severity and decreased need for surgery - Market Potential: High overlap between chronic rhinosinusitis and asthma (approximately 20% of asthma patients also have nasal polyps), enhancing TEZSPIRE's market reach [35][36][37][42][45] Eosinophilic Esophagitis (EoE) - Unmet Need: Current treatments are limited, primarily involving proton pump inhibitors and corticosteroids - Prevalence: Estimated at 1 in 700 people in the U.S. - Phase III Study: Expected data in the second half of 2026, with potential for TEZSPIRE to address this unmet need [47][49][51] Competitive Landscape - Dazodalibep vs. Nipocalimab: Dazodalibep is the first therapy to demonstrate efficacy in both subgroups of Sjögren's syndrome in Phase II, with ongoing Phase III studies to confirm its effectiveness [32][34] Future Outlook - Execution Focus: Amgen aims to build penetration in existing indications before exploring new ones for TSLP-targeted therapies - Inhaled TSLP Therapy: AMG 104, an inhaled TSLP antibody fragment, is in Phase II trials, with potential to provide an alternative to injected biologics for asthma management [65][66][70][74] Conclusion - Amgen is positioned to leverage its innovative therapies across multiple autoimmune conditions, with significant clinical data supporting the efficacy of its products. The company is focused on executing its current strategies while preparing for future opportunities in the evolving therapeutic landscape.