- The stock price of BeyondSpring Inc (NASDAQ: BYSI) fell by over 55% during intraday trading today. This is why it happened.
The stock price of BeyondSpring Inc (NASDAQ: BYSI) – a global pharmaceutical company focused on the development of cancer therapeutics – fell by over 55% during intraday trading today. Investors are responding negatively to BeyondSpring Pharmaceuticals announcing it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) 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 they have completed their review of the application and have 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 3) were not sufficiently robust to demonstrate benefit and that a second well-controlled trial would be required to satisfy the substantial evidence required to support the CIN indication.
BeyondSpring remains confident in the efficacy and safety data for plinabulin in combination with G-CSF for the prevention of CIN. And the company expects to work closely with the FDA to consider the possible future clinical pathway for CIN, which may include a second study.
Plinabulin is considered the first drug candidate submitted for FDA approval that has the potential to work in the critical first week of chemotherapy treatment before G-CSF is effective, to prevent the onset and improve clinical outcomes of CIN.
“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.”
— Dr. Lan Huang, BeyondSpring’s co-founder, chief executive officer and chairwoman
Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.