U.S. FDA declines to approve BeyondSpring's neutropenia drug, shares plunge (updated)

Beyondspring

01/12/2021 13:52

(Adds background, details on FDA decision, shares)
    Dec 1 (Reuters) - BeyondSpring  BYSI.O  said on Wednesday
the U.S. Food and Drug Administration (FDA) had declined to
approve its drug candidate for neutropenia, citing need for an
additional study, sending the company's shares down 52% in
premarket trade.    
    Neutropenia, a decrease in the number of white blood cells
(WBCs) is a common complication of chemotherapy that kills
healthy WBCs along with cancer cells, increasing a patient's
susceptibility to infections.
    The regulator indicated that results from the company's
single late-stage trial not did not provide enough evidence on
the benefits of the drug, plinabulin, and that a second trial
would be required to support the marketing application,
BeyondSpring said. 
    Plinabulin in combination with an anti-infection drug met
the main goal of the late-stage trial, demonstrating improvement
in the rate of prevention of neutropenia, the company had said
last year.  urn:newsml:reuters.com:*:nGNX57Y0w1   
    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 pathway for
neutropenia prevention.
    


 (Reporting by Amruta Khandekar; Editing by Maju Samuel and
Vinay Dwivedi)
 ((Amruta.Khandekar@thomsonreuters.com;))