A small biopharma stock soars 198% after the company says it will seek FDA approval following a successful cancer-drug trial

Stock photo of doctors analyzing a lung cancer scan.

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.