BeyondSpring receives FDA Fast Track designation for Plinabulin lung cancer program

• BeyondSpring received FDA Fast Track designation for Plinabulin combined with docetaxel in previously treated advanced non-squamous lung cancer.
• The company entered an agreement to sell BeyondSpring Ltd, which indirectly holds its majority interest in Chinese subsidiary Bulin.
• BeyondSpring expects the arrangement to reduce its cash requirements for the Phase 3 DUBLIN-4 trial.

BeyondSpring (NASDAQ:BYSI) announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to Plinabulin in combination with docetaxel for previously treated advanced non-squamous lung cancer.

The designation applies to patients without actionable genomic alterations whose disease has progressed following treatment with anti-PD-(L)1 therapy and platinum-based chemotherapy.

BeyondSpring also entered into an agreement to sell BeyondSpring Ltd., a subsidiary that indirectly holds its majority ownership interest in Chinese subsidiary Bulin, to Biolin Investment.

Under the agreement, Biolin’s non-cash consideration consists of an obligation to support China-based clinical trial activities. BeyondSpring will retain access to clinical data generated from those activities.

The company’s ongoing Phase 3 DUBLIN-4 trial is expected to enroll approximately 442 patients globally, with about half of participants expected to come from China.

The study is evaluating Plinabulin plus docetaxel compared with docetaxel alone.

Overall survival is the primary endpoint of DUBLIN-4, with an interim analysis planned after 221 progression-free survival events.

BeyondSpring said the transaction structure is expected to substantially reduce its cash requirements for the DUBLIN-4 study.