BeyondSpring Inc. (BYSI) shares are falling more than 53 percent on Wednesday morning trade after FDA issued a complete response letter for a new drug application for Plinabulin in combination with granulocyte colony-stimulating factor and said it cannot be approved in its present form. The NDA has intended for the prevention of chemotherapy-induced neutropenia or low levels of white blood cells.
FDA in its letter said the single registrational trial was not sufficiently robust to demonstrate benefit and require a second well-controlled trial.
Currently, shares are at $6.15, down 51.91 percent from the previous close of $12.77 on a volume of 12,172,934. For the 52-week period, the shares have traded in a range of $5.50-$33.00 on average volume of 1,072,116.
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