Compelling Zoci clinical data — strong intracranial activity
In extensive-stage small cell lung cancer at the 1.6 mg/kg dose, Zoci showed a confirmed intracranial overall response rate of 62.5% and a best intracranial response approaching 69% (including 4 complete responses). Grade ≥3 treatment-related adverse events were ~16%. These intracranial responses and favorable safety profile were presented as best-in-class signals.
Differentiation in extrapulmonary neuroendocrine carcinoma
Zoci demonstrated a confirmed overall response rate of 38.2% in extrapulmonary neuroendocrine carcinoma versus historically ~18% for commonly used regimens, supporting potential registrational pathways and extension studies.
Robust global development plan and partnerships
Registrational Phase III DLLEVATE study enrolling on track to complete enrollment in H1 2027, positioning for an interim analysis and potential accelerated approval submission. Strategic global collaborations announced with Amgen and Boehringer Ingelheim to evaluate combinations (including a triplet cohort with Amgen already enrolling), expanding combination strategy and development options.
Advanced and diversified pipeline beyond Zoci
Multiple programs advancing: ZL-1503 (IL-13/IL-31 bispecific) with preclinical data showing rapid durable inhibition and Phase I/Ib in atopic dermatitis underway; healthy volunteer and AD cohorts expected H2 2026 with Phase II planned. ZL-6201 is in clinic and ZL-1311 expected to enter clinic by year-end.
Commercial momentum and upcoming launches
Commercial catalysts include KarXT launch in Q2 (first novel schizophrenia mechanism in decades) with guideline inclusion ahead of launch, potential regulatory approval for Tivdak this year, and expectation of Tumor Treating Fields approval for locally advanced pancreatic cancer by year-end—opportunities to leverage existing commercial infrastructure.
Growth pockets and large addressable opportunities
VYVGART delivered double-digit volume growth year-over-year in Q1; XACDURO showed strong underlying patient demand and expanding hospital adoption; biologic penetration in gMG maintenance remains low (~15%), indicating runway for future growth.
Solid balance sheet and focus on efficiency
Ended Q1 with $761.3 million cash. Regional business is commercially profitable. Company is embedding AI across R&D and commercial to drive speed, precision and cost efficiencies and expects sequential product revenue improvement over the next nine months with a return to growth in 2027.