BeyondSpring Shares Crater After FDA Rejects Plinabulin Application

The FDA has issued a Complete Response Letter to BeyondSpring Pharmaceuticals Inc's BYSI marketing application seeking approval for plinabulin to prevent chemotherapy-induced neutropenia (CIN).The application covers plinabulin in combination with granulocyte colony-stimulating factor (G-CSF).

• The CRL indicated that the results of the single registrational trial (106 Phase 3) were not sufficiently robust to demonstrate benefit.
• Related: BeyondSpring Stock Is Up More than 300%: What You Need To Know?
• Secondly, a well-controlled trial would be required to satisfy the substantial evidence necessary to support the CIN indication.
• The Company expects to work closely with the FDA to consider the possible future clinical pathway for CIN, including a second study.
• BeyondSpring shares plunged after sharing the final intention-to-treat (ITT) dataset from its DUBLIN-3 Phase 3 trial of plinabulin.
• See here Benzinga's Full FDA Calendar.
• Price Action: BYSI shares are down 53.50% at $5.94 during the market session on the last check Wednesday.