What happened
Shares of BeyondSpring (BYSI 1.29%) soared on Wednesday after the pharmaceutical company released promising clinical trial results for its investigational lung cancer treatment. By the close of trading, BeyondSpring's stock price was up 176% after rising as much as 211% earlier in the day.
So what
A phase 3 trial of BeyondSpring's plinabulin treatment in combination with chemotherapy medication docetaxel to treat second and third line non-small cell lung cancer (NSCLC) reached its primary endpoint of statistically significant improvement in overall survival versus docetaxel alone.
The combination treatment study also met its secondary endpoints, including significantly improving overall response rate (the proportion of patients whose tumor is reduced by a drug), progression-free survival rate, and 24- and 36-month overall survival rates. Better still, it demonstrated a significant reduction in the incidence of grade 4 neutropenia, a condition in which an abnormally low number of white blood cells leads to an increased risk of infection.
Investors drove BeyondSpring's share price sharply higher on Wednesday. Image source: Getty Images.
CEO Dr. Lan Huang said in a press release that the results "further validate our conviction that plinabulin, as an immune anti-cancer agent, has the potential to be a cornerstone therapy for many solid tumors."
Now what
BeyondSpring hopes to obtain approval for plinabulin in combination with docetaxel in NSCLC from the U.S. Food and Drug Administration (FDA) and China's National Medical Products Administration (NMPA). The company expects to submit its new drug application (NDA) in the first half of 2022.
