BeyondSpring Files US-China Application For Plinabulin G-CSF Treatment In Chemo-Induced Neutropenia

BeyondSpring Inc BYSI has submitted marketing applications in the U.S. and China seeking approval for plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN).
Neutropenia is a condition wherein a person has a low level of neutrophils, a white blood cell that helps the body fight infection.
The submission is based on data from PROTECTIVE-2 Phase 3 study, which showed that plinabulin combined with pegfilgrastim demonstrated superior CIN prevention benefit compared to pegfilgrastim alone.
The study met the primary endpoint, with a statistically significant improvement in the rate of prevention of grade 4 neutropenia (improved from 13.6% to 31.5%).
Price Action: BYSI shares are up 4.1% higher at $11.07 in the premarket trading on the last check Thursday.