Dyax Hit With FDA Drug Delay
Cambridge, MA-based Dyax (NASDAQ: DYAX) said today that its lead drug in development, DX-88, failed to win FDA approval on schedule. The company said it needs to answer more questions about the chemistry, manufacturing, and controls section of its application, and for a risk evaluation and mitigation strategy. The company doesn’t need to do more clinical trials. The product is for treating acute attacks of hereditary angioedema, a condition that causes painful swelling of the extremities.