Shares of MGI Pharma took a positive bounce on the news that the FDA had approved its blood cell therapy Dacogen. Dacogen is designed to treat myelodysplastic syndromes (MDS), a disease category that is characterized by poorly functioning blood cells. Phase III data suggest that about one in five patients respond to the drug, which will be launched in the second quarter. SuperGen developed Dacogen and now stands to benefit from its sale.
"This approval is a significant milestone for SuperGen. Over the course of more than seven years, SuperGen developed Dacogen by working with scientists, clinicians, patient advocacy groups, and regulatory agencies to get this product approved for patients with MDS," said James S. Manuso, Ph.D., president and CEO of SuperGen.
- here's the AP report on the FDA approval