NEW YORK (AP) -- Immunomedics said Wednesday its cancer drug IMMU-132 will receive orphan drug incentives as a treatment for small cell lung cancer.
The Food and Drug Administration awards orphan drug status to medications that are designed to treat diseases that affect fewer than 200,000 people in the U.S. and represent major improvements in treatment. The status comes with regulatory incentives, reduced fees, a faster review by the FDA, and it means competing drugs could be blocked from the market for up to seven years.
Shares of Immunomedics rose 42 cents, or 9.5 percent, to $4.84 in midday trading.
Immunomedics Inc. has no approved drugs. Its most advanced experimental drug is called epratuzumab. The company is studying epratuzumab as a treatment for leukemia and lymphoma, and it has licensed the drug to UCB SA as a treatment for conditions other than cancer. UCB is conducting late-stage testing of the drug as a treatment for lupus.
The Morris Plains, N.J., company said IMMU-132 is in mid-stage testing as a treatment for small cell lung cancer and other types of solid tumors.
- Health Care Industry
- small cell lung cancer
- Food and Drug Administration
- cancer drug
- orphan drug