By Colin Kellaher


BeyondSpring Inc. on Wednesday said the U.S. Food and Drug Administration has rejected its application seeking approval of plinabulin in combination with granulocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia.

The New York biopharmaceutical company said it received an FDA complete response letter, indicating that the agency won't approve the application in its current form.

BeyondSpring said the FDA found that the results of the company's single registrational Phase 3 trial weren't sufficiently robust to demonstrate benefit, and that a second well controlled study would be needed to satisfy the substantial evidence requirement to support the proposed indication.

BeyondSpring said it plans to request a meeting with the FDA, adding that it expects to work closely with the agency to consider the possible future clinical pathway for the drug in chemotherapy-induced neutropenia, which may include a second study.

Trading in shares of BeyondSpring was halted premarket on Wednesday.


Write to Colin Kellaher at


(END) Dow Jones Newswires

December 01, 2021 08:32 ET (13:32 GMT)

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