Why BeyondSpring Shares Are Diving Today

BeyondSpring Inc BYSI is trading significantly lower Wednesday after the company announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the plinabulin NDA for prevention of chemotherapy-induced neutropenia.

The FDA issued the CRL to indicate that they have completed their review of the application and have determined that it cannot be approved in its current form.

"BeyondSpring strongly believes that plinabulin in combination with G-CSF has significant potential to raise the standard of care in CIN, a devastating side effect of chemotherapy. The company plans to request a meeting with the FDA and remains committed to its goal of bringing plinabulin to cancer patients in need globally," said Lan Huang, co-founder and CEO of BeyondSpring.

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BeyondSpring is engaged in clinical stage biopharmaceutical activities focused on the development of cancer therapies.

BYSI Price Action: BeyondSpring has traded as high as $33 over a 52-week period. It's making new 52-week lows Wednesday.

The stock was down 59.30% at $5.20 at time of publication.