“Dazodalibet, our first-in-class CD40 ligand-targeting fusion protein, continues to progress with two Phase III studies in Sjogren’s disease now fully enrolled. These studies address both systemic and symptomatic disease, and both are expected to complete later this year.”

In context

“ross our portfolio. For APLISNA, we recently received European Commission approval for generalized myasthenia gravis. Supported by a strong biological rationale, we expect to initiate two pivotal Phase III studies of aplisna in autoimmune hepatitis and chronic inflammatory demyelinating by the second half of this year. We are also advancing TEPEZZA, where we recently reported positive Phase III top-line data for subcutaneous administration via an on-body injector. These data demonstrated robust efficacy in patients with thyroid eye disease consistent with intravenous administration alongside a favorable safety profile. Subcutaneous administration of TEPEZZA represents an important step forward in improving convenience, and expanding treatment options for patients with thyroid eye disease. Dazodalibet, our first-in-class CD40 ligand-targeting fusion protein, continues to progress with two Phase III studies in Sjogren’s disease now fully enrolled. These studies address both systemic and symptomatic disease, and both are expected to complete later this year. As publicly disclosed, the FDA proposed to withdraw the approval of Tabneos. We continue to believe that Tabneos is an important medicine for patients with ANCA-associated vasculitis, a rare life-threatening disease with limited treatment options. We are confident in the benefit-risk profile of this medicine and expect to engage further with the FDA on this topic. Turning to oncology, our bispecific T cell engager, or BiTE, platform continues to deliver meaningful impact for patients with advanced cancer. Imdeltra is emerging as a standard of care in second-line extensive-stage small cell lung cancer, delivering an unprecedented survival benefit in a disease that has seen very little innovation for decades. As we work to advance Imdeltra into earlier lines of therapy, we are encouraged by”