M&A
confidence high
sentiment positive
materiality 0.65
BeyondSpring wins FDA Fast Track for Plinabulin in post-ICI NSCLC; sells China unit to fund DUBLIN-4
BeyondSpring Inc.
- FDA granted Fast Track designation to Plinabulin plus docetaxel for 2L/3L advanced non-squamous NSCLC without actionable genomic alterations, post-ICI and platinum chemo.
- DUBLIN-4 Phase 3: ~442 patients randomized 1:1, overall survival primary endpoint with PFS and ORR secondary; prespecified interim analysis at 221 PFS events.
- BeyondSpring will sell BeyondSpring Ltd, which indirectly holds its majority stake in Dalian Wanchunbulin (Bulin), to Biolin Investment for no cash; Biolin funds the China portion of DUBLIN-4.
- If Bulin misses Target Enrollment within 3 years after closing and the shortfall is 90% or more, Biolin must return 100% of the Equity Interests to BeyondSpring.
- ATM program with Citizens JMP Securities covers up to 9,200,000 ordinary shares; agent commission up to 3.0% of gross proceeds.