BeyondSpring Wins FDA Fast Track for Plinabulin in NSCLC; Stock Jumps 44%

BeyondSpring (BYSI) said on Tuesday 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 evaluated for anticancer and immune-modulating effects. The Phase 3 DUBLIN-4 study plans to enroll 442 patients, comparing 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. BYSI closed Monday at $1.12, up 44.11%. In premarket trading, the stock traded at $1.03, down 8.04%.