(RTTNews) - Tuesday, BeyondSpring (BYSI) said the FDA granted Fast Track designation to Plinabulin plus docetaxel for advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) following progression on immune checkpoint inhibitor therapy and chemotherapy.
Plinabulin is an investigational small-molecule cancer therapy being evaluated for its anticancer and immune-modulating effects.
The Phase 3 DUBLIN-4 study plans to enroll 442 patients and compare Plinabulin plus docetaxel with docetaxel alone, with overall survival as the primary endpoint.
BeyondSpring also entered a strategic transaction under which an investor will fund the China portion of DUBLIN-4, expected to account for about half of total enrollment.
BeyondSpring's closed Monday's trading at $1.12, up 44.11%. In the premarket trading, the stock is at $1.03, down 8.04%.