Dec. 1 (Reuters) – BeyondSpring (BYSI.O) said on Wednesday that the United States Food and Drug Administration (FDA) had refused to approve its neutropenia drug candidate, citing the need for further study, saying drop the company’s stock by 52% in pre-commercialization Commerce.
Neutropenia, a decrease in the number of white blood cells (WBCs) is a common complication of chemotherapy which kills healthy white blood cells as well as cancer cells, thus increasing the patient’s susceptibility to infections.
The regulator said the results of the company’s only late-stage trial did not provide enough evidence on the benefits of the drug, plinabulin, and that a second trial would be needed to support market demand, said BeyondSpring.
Plinabulin in combination with an anti-infective drug achieved the primary goal of the late-stage trial, demonstrating an improvement in the rate of prevention of neutropenia, the company said last year.
BeyondSpring, which is also developing the drug as a potential treatment for non-small cell lung cancer, said it intends to work with the FDA to determine the drug’s route for the prevention of neutropenia.
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Reporting by Amruta Khandekar; Editing by Maju Samuel and Vinay Dwivedi
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