After surging nearly 9% over the past five sessions, Zai Lab (NASDAQ:ZLAB) shares gained an additional 12% in the pre-market session today following the biopharmaceutical company’s recent regulatory win for repotrectinib in China.
The National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has granted breakthrough therapy designation for repotrectinib for the treatment of advanced solid tumors in patients with NTRK gene fusion (after prior TRK tyrosine kinase inhibitor treatment). NTRK gene fusions act as oncogenic drivers for multiple tumor types in both adults and children.
The designation is backed by data from the Phase 1/2 Trident-1 clinical trial, which included subjects from both global and Chinese populations. Impressively, this is the fourth breakthrough therapy designation for the investigational candidate. In June of this year, the NMPA accepted ZLAB’s new drug application for repotrectinib for the treatment of locally advanced or metastatic ROS-1-positive non-small cell lung cancer in adult patients.
Overall, the Street has a consensus price target of $52.83 for ZLAB, alongside a Strong Buy consensus rating. This points to a mouth-watering 102.4% potential upside in the stock.
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