- BeyondSpring surged 197% Wednesday after announcing it is seeking FDA approval for its cancer drug.
- The company said plinabulin met the primary endpoint of significantly improving the overall survival of patients.
- Shares of BeyondSpring surged to their highest price since May 2018.
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Shares of BeyondSpring surged 197% on Wednesday after the New York-based biopharmaceutical company announced it is now seeking approval from the US Food and Drug Administration for its cancer-drug trial.
Shares of the company were trading at their highest level since May 2018. The stock was up 188%, at $US27.74 ($AU37) as of 1:32 p.m. ET.
The company on Wednesday said plinabulin, its lead drug, met the primary endpoint of significantly improving the overall survival of patients during the DUBLIN-3 phase three trial of its lung cancer treatment.
The study also met secondary endpoints including boosting overall response rate, progression-free survival, and 24-36 months of overall survival rates.
BeyondSpring also said it plans to seek approval from China’s drug regulator.
Dr. Lan Huang, co-founder, CEO, and chair, said she will set a pre-non-disclosure agreement meeting with the FDA in 2021 to agree on the contents of their NDA. This, she said, will support a submission in the first half of 2022.
“The strong results from DUBLIN-3 further validate our conviction that plinabulin, as an immune anti-cancer agent, has the potential to be a cornerstone therapy for many solid tumors,” Huang said.
Plinabulin is a novel, intravenous-infused, patent-protected drug candidate for non-small cell lung cancer.
The company’s stock last week closed at a record-low.