BeyondSpring tanks, as it gets CRL for plinabulin NDA

2 December 2021

Sino-American cancer drug developed BeyondSpring Pharmaceuticals (Nasdaq: BYSI) saw its shares plummet more than 60% yesterday, and a further 5.7% to $4.65 pre-market today, after it revealed receipt of a Complete Response Letter (CRL) from the US Food and Drug Administration for the New Drug Application (NDA) seeking approval of plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN).

The FDA issued the CRL to indicate that it has completed its review of the application for plinabulin, which is the company’s lead asset, and has determined that it cannot be approved in its present form.

The FDA’s CRL indicated that the results of the single registrational trial (106 Phase III) was not sufficiently robust to demonstrate benefit and that a second well controlled trial would be required to satisfy the substantial evidence requirement to support the CIN indication.

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