Thinly traded micro cap Ignyta (RXDX +7.4%) is up on increased volume in early trading. After the close yesterday, it updated investors on lead product candidate entrectinib, a selective tyrosine kinase inhibitor in development for the treatment of a variety of tumor types.
Enrollment in the Phase 2 STARTRK-2 registration study is 85% there with completion expected next quarter. According to ClinicalTrials.gov, the estimated final data collection date for the primary endpoint is October. The estimated study completion date is October 2018. The company says top-line should be available in H1 2018.
Based on FDA feedback, the company's New Drug Application (NDA) will support a TRK fusion-positive, tissue agnostic indication (several dozen TRK fusion-positive patients are currently enrolled in STARTRK-2).
Ignyta will simultaneously pursue an NDA for entrectinib to support a ROS1 fusion-positive non-small cell lung cancer (NSCLC) indication (more than 50 ROS1 fusion-positive patients are currently enrolled in STARTRK-2).
Previously: Ignyta initiates mid-stage study of entrectinib (Sept. 30, 2015)