US Stock Market Move | ZAI LAB (ZLAB.US) rose more than 10%, and Zoci was granted fast track designation by the FDA.

On Monday, ZAI LAB (ZLAB.US) rose more than 10%, closing at $20.50. In terms of news, ZAI LAB announced on Monday that its in-house developed antibody drug conjugate (ADC) targeting DLL3, Zoci (zocilurtatug pelitecan, formerly ZL-1310), has been granted Fast Track designation by the U.S. FDA for the treatment of extrapulmonary neuroendocrine carcinoma (epNECs) that has progressed after first-line standard therapy. It is reported that epNECs are aggressive and poorly prognosed malignant tumors, with approximately 100,000 people worldwide suffering from the disease. There is a significant unmet medical need as there are no approved targeted therapies or standard treatment options for epNECs. Previously in May 2025, Zoci had received Fast Track designation from the FDA for the treatment of extensive-stage small cell lung cancer (ES-SCLC). Furthermore, results from a Phase Ib/II registration study presented at the 2026 AACR Annual Meeting showed that Zoci, when used in patients with treatment-refractory epNEC, achieved an objective response rate (ORR) of 38.2% and demonstrated manageable safety, with neutropenia being the only 3 Grade and commonly occurring treatment-related adverse event. The clinical development program of Zoci for epNEC is currently progressing towards registration, and plans for registration have been communicated with regulatory authorities.