U.S. FDA Grants Orphan Drug Designation to Zai Lab’s DLL3-Targeting ADC Zocilurtatug Pelitecan (Zoci) for the Treatment of Neuroendocrine Carcinomas (NECs)
Monday, August 3, 2026 BiopharmaWatch Research 1 min read
Key Takeaway: Zai Lab Limited has received Orphan Drug Designation from the U.S. FDA for zocilurtatug pelitecan (Zoci), a DLL3-targeting ADC aimed at treating neuroendocrine carcinomas (NECs). This designation highlights the drug's potential as a first-in-class therapy for these aggressive malignancies, which currently lack targeted treatment options.
Price reaction · baseline $18.27 (2026-07-31 close) · hit pre-market · clean, no other ZLAB news in the window
day 0 close · peak
-0.5%
Market Sentiment Analysis
POSITIVE FACTORS
FDA grants Orphan Drug Designation to Zai Lab's zocilurtatug pelitecan.
Zoci targets DLL3, a promising approach for treating NECs.
Potential first-in-class therapy for aggressive neuroendocrine carcinomas.
BiopharmaWatch Analysis
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Best trade, last catalyst
+104%
120-day peak, hindsight
Typical move
8.5%
average across 4 past catalysts
Cash runway
~164 mo
Low dilution risk
Lead asset
ZL-1211
Phase 1 · Advanced Solid Tumor
Full Press Release Details
SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to zocilurtatug pelitecan (zoci, formerly ZL-1310), the Company’s potential first-in-class Delta-like ligand 3 (DLL3) antibody-drug conjugate (ADC), for the treatment of neuroendocrine carcinomas (NECs). NECs are aggressive malignancies that frequently express DLL3. There are no available targeted therapies
Frequently Asked Questions
What is zocilurtatug pelitecan (Zoci)?
Zoci is a DLL3-targeting antibody-drug conjugate developed by Zai Lab for treating neuroendocrine carcinomas.
What does Orphan Drug Designation mean?
Orphan Drug Designation is granted by the FDA to encourage development of treatments for rare diseases.
What type of cancer does Zoci target?
Zoci targets neuroendocrine carcinomas, which are aggressive malignancies expressing DLL3.
Why is Zoci significant for NEC treatment?
Zoci represents a potential first-in-class therapy for NECs, which currently lack targeted treatment options.