For thos that are interested in a little more info on BYSI. It was a phase III registrational trial that succeeded. The stock is up about 135% at the moment.
BeyondSpring Shares Rally After Lung Cancer Trial Meets Endpoints
By Robb M. Stewart
(Dow Jones) -- BeyondSpring Inc. shares more than doubled in early trading Wednesday after the pharmaceutical company's trial of a lung cancer treatment met its main targets.
The company said it plans to seek approval from U.S. and Chinese regulators for plinabulin, its lead asset, in combination with docetaxel for the treatment of a type of second- and third-line nonsmall cell lung cancer following the positive trial results.
In morning trading, its shares rallied to $27.11 from the previous close of $9.63, swinging them to a sharp gain so far this year. Volume at the time was almost 13 million shares, compared with a 30-day average of under 200,000.
The pharmaceutical company Wednesday said its Dublin-3 registrational trial of plinabulin in combination with docetaxel met the primary endpoint showing statistically significant improvement in overall survival for the combination versus docetaxel alone. Plinabulin is a selective immunomodulating microtubule-binding agent, which is a potent antigen presenting cell inducer.
The study also met key secondary endpoints showing a statistically significant improvement for the combination compared with docetaxel alone in overall response rate, progression-free survival, and 24- and 36-month overall survival rates, and significant reduction in incidence of Grade 4 neutropenia, the company said.
"The success of the DUBLIN-3 study represents proof-of-concept of plinabulin's immune-enhancing mechanism of action that is complimentary to that of checkpoint inhibitors, and which is the rationale for it to be combined as triple (immuno-oncology) combinations in multiple tumor indications," said Ramon Mohanlal, chief medical officer and executive vice president of research and development at BeyondSpring.
The treatment of second- and third-line nonsmall cell lung cancer, especially with EGFR wild type where tyrosine kinase inhibitors don't work, is an area of severe unmet medical needs, said Trevor Feinstein of the Piedmont Cancer Institute and a principal investigator for Dublin-3.
The Dublin-3 Phase 3 trial is a randomized, single blind to patients, active controlled, global trial that enrolled 559 patients in second- and third-line nonsmall cell lung cancer, epidermal growth factor receptor wild type, with measurable lung lesion. The company said it plans to present full data at a coming medical conference.