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Zai Lab Receives US FDA Fast-Track Designation for Potential Small Cell Lung Cancer Treatment
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Zai Lab Receives US FDA Fast-Track Designation for Potential Small Cell Lung Cancer Treatment
May 26, 2025 10:09 AM

07:48 AM EDT, 05/19/2025 (MT Newswires) -- Zai Lab ( ZLAB ) said Monday that the US Food and Drug Administration has granted fast-track designation to ZL-1310, the company's potential antibody-drug conjugate for the treatment of extensive-stage small cell lung cancer.

The drug, currently being evaluated in a phase 1 clinical trial already received an FDA orphan drug designation for small cell lung cancer, the company said.

Fast-track designation will mean more frequent engagements with the FDA and eligibility for accelerated approval and priority review, the company said.

Shares of the company were up more than 2% in recent premarket activity.

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